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3. Reply to P. de Boissieu et al

Author

Spigel, David R., Dowlati, Afshin, Chen, Yuanbin, Navarro, Alejandro, Chih-Hsin Yang, James, Stojanovic, Goran, Jove, Maria, Rich, Patricia, Andric, Zoran G., Wu, Yi-Long, Rudin, Charles M., Chen, Huanyu, Zhang, Li, Yeung, Stanley, Benzaghou, Fawzi, Paz-Ares, Luis, and Bunn, Paul A.

Published
2024
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8. Long-term avelumab in advanced non-small-cell lung cancer: summaries and post hoc analyses from JAVELIN Solid Tumor

Author

Hrinczenko, Borys, Iannotti, Nicholas, Goel, Sanjay, Spigel, David, Safran, Howard, Taylor, Matthew H, Bennouna, Jaafar, Wong, Deborah J, Kelly, Karen, Verschraegen, Claire, Bajars, Marcis, Manitz, Juliane, Ruisi, Mary, and Gulley, James L

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Lung, Clinical Trials and Supportive Activities, Lung Cancer, Cancer, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Antibodies, Monoclonal, Humanized, B7-H1 Antigen, Carcinoma, Non-Small-Cell Lung, Disease Progression, Humans, Lung Neoplasms, clinical trials, immunotherapy, lung, metastasis, solid tumors, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Background: This study examined patients with advanced non-small-cell lung cancer who received long-term avelumab (anti-PD-L1) in a large phase Ib trial (JAVELIN Solid Tumor). Methods: Patients receiving >2 years of avelumab were reviewed and exploratory descriptive analyses were conducted. Results: Individuals with varying baseline characteristics who had received up to 6 years of avelumab were reviewed. Overall, 37/340 (10.9%) had received ≥2 years of treatment; in this subgroup, best response was complete response in 5.4%, partial response in 59.5% and stable disease in 29.7%; 51.4% had continued treatment beyond disease progression. Conclusions: In this study, 11% of patients with advanced non-small-cell lung cancer received ≥2 years of avelumab treatment and experienced prolonged response or continued clinical benefit. Clinical Trial Registration: NCT02395172 (ClinicalTrials.gov).

Published
2022

9. A Phase Ib Study Assessing the Safety, Tolerability, and Efficacy of the First-in-Class Wee1 Inhibitor Adavosertib (AZD1775) as Monotherapy in Patients with Advanced Solid Tumors

Author

Bauer, Todd M., Moore, Kathleen N., Rader, Janet S., Simpkins, Fiona, Mita, Alain C., Beck, J. Thaddeus, Hart, Lowell, Chu, Quincy, Oza, Amit, Tinker, Anna V., Imedio, Esteban Rodrigo, Kumar, Sanjeev, Mugundu, Ganesh, Jenkins, Suzanne, Chmielecki, Juliann, Jones, Suzanne, Spigel, David, and Fu, Siqing

Published
2023
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10. In situ tumour arrays reveal early environmental control of cancer immunity

Author

Ortiz-Muñoz, Guadalupe, Brown, Markus, Carbone, Catherine B., Pechuan-Jorge, Ximo, Rouilly, Vincent, Lindberg, Henrik, Ritter, Alex T., Raghupathi, Gautham, Sun, Qianbo, Nicotra, Tess, Mantri, Shreya R., Yang, Angela, Doerr, Jonas, Nagarkar, Deepti, Darmanis, Spyros, Haley, Benjamin, Mariathasan, Sanjeev, Wang, Yulei, Gomez-Roca, Carlos, de Andrea, Carlos Eduardo, Spigel, David, Wu, Thomas, Delamarre, Lelia, Schöneberg, Johannes, Modrusan, Zora, Price, Richard, Turley, Shannon J., Mellman, Ira, and Moussion, Christine

Published
2023
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11. Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results

Author

Yap, Timothy A., Fontana, Elisa, Lee, Elizabeth K., Spigel, David R., Højgaard, Martin, Lheureux, Stephanie, Mettu, Niharika B., Carneiro, Benedito A., Carter, Louise, Plummer, Ruth, Cote, Gregory M., Meric-Bernstam, Funda, O’Connell, Joseph, Schonhoft, Joseph D., Wainszelbaum, Marisa, Fretland, Adrian J., Manley, Peter, Xu, Yi, Ulanet, Danielle, Rimkunas, Victoria, Zinda, Mike, Koehler, Maria, Silverman, Ian M., Reis-Filho, Jorge S., and Rosen, Ezra

Published
2023
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13. Personalized neoantigen vaccine NEO-PV-01 with chemotherapy and anti-PD-1 as first-line treatment for non-squamous non-small cell lung cancer

Author

Awad, Mark M., Govindan, Ramaswamy, Balogh, Kristen N., Spigel, David R., Garon, Edward B., Bushway, Meghan E., Poran, Asaf, Sheen, Joong Hyuk, Kohler, Victoria, Esaulova, Ekaterina, Srouji, John, Ramesh, Suchitra, Vyasamneni, Rohit, Karki, Binisha, Sciuto, Tracey E., Sethi, Himanshu, Dong, Jesse Z., Moles, Melissa A., Manson, Kelledy, Rooney, Michael S., Khondker, Zakaria S., DeMario, Mark, Gaynor, Richard B., and Srinivasan, Lakshmi

Published
2022
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14. STK11/LKB1 Mutations and PD-1 Inhibitor Resistance in KRAS-Mutant Lung Adenocarcinoma.

Author

Skoulidis, Ferdinandos, Goldberg, Michael, Greenawalt, Danielle, Hellmann, Matthew, Awad, Mark, Gainor, Justin, Schrock, Alexa, Hartmaier, Ryan, Trabucco, Sally, Gay, Laurie, Ali, Siraj, Elvin, Julia, Singal, Gaurav, Ross, Jeffrey, Fabrizio, David, Szabo, Peter, Chang, Han, Sasson, Ariella, Srinivasan, Sujaya, Kirov, Stefan, Szustakowski, Joseph, Vitazka, Patrik, Edwards, Robin, Bufill, Jose, Sharma, Neelesh, Ou, Sai-Hong, Peled, Nir, Spigel, David, Rizvi, Hira, Aguilar, Elizabeth, Carter, Brett, Erasmus, Jeremy, Halpenny, Darragh, Plodkowski, Andrew, Long, Niamh, Nishino, Mizuki, Denning, Warren, Galan-Cobo, Ana, Hamdi, Haifa, Hirz, Taghreed, Tong, Pan, Wang, Jing, Rodriguez-Canales, Jaime, Villalobos, Pamela, Parra, Edwin, Kalhor, Neda, Sholl, Lynette, Sauter, Jennifer, Jungbluth, Achim, Mino-Kenudson, Mari, Azimi, Roxana, Elamin, Yasir, Zhang, Jianjun, Leonardi, Giulia, Wong, Kwok-Kin, Lee, J, Papadimitrakopoulou, Vassiliki, Wistuba, Ignacio, Miller, Vincent, Frampton, Garrett, Wolchok, Jedd, Shaw, Alice, Jänne, Pasi, Stephens, Philip, Rudin, Charles, Geese, William, Albacker, Lee, Heymach, John, and Jiang, Fei

Subjects
AMP-Activated Protein Kinase Kinases, Adenocarcinoma of Lung, Adult, Aged, Aged, 80 and over, Animals, Antineoplastic Agents, Immunological, Disease Models, Animal, Drug Resistance, Neoplasm, Humans, Immunotherapy, Lung Neoplasms, Male, Mice, Middle Aged, Mutation, Nivolumab, Prognosis, Programmed Cell Death 1 Receptor, Progression-Free Survival, Protein Serine-Threonine Kinases, Proto-Oncogene Proteins p21(ras)
Abstract

KRAS is the most common oncogenic driver in lung adenocarcinoma (LUAC). We previously reported that STK11/LKB1 (KL) or TP53 (KP) comutations define distinct subgroups of KRAS-mutant LUAC. Here, we examine the efficacy of PD-1 inhibitors in these subgroups. Objective response rates to PD-1 blockade differed significantly among KL (7.4%), KP (35.7%), and K-only (28.6%) subgroups (P < 0.001) in the Stand Up To Cancer (SU2C) cohort (174 patients) with KRAS-mutant LUAC and in patients treated with nivolumab in the CheckMate-057 phase III trial (0% vs. 57.1% vs. 18.2%; P = 0.047). In the SU2C cohort, KL LUAC exhibited shorter progression-free (P < 0.001) and overall (P = 0.0015) survival compared with KRASMUT;STK11/LKB1WT LUAC. Among 924 LUACs, STK11/LKB1 alterations were the only marker significantly associated with PD-L1 negativity in TMBIntermediate/High LUAC. The impact of STK11/LKB1 alterations on clinical outcomes with PD-1/PD-L1 inhibitors extended to PD-L1-positive non-small cell lung cancer. In Kras-mutant murine LUAC models, Stk11/Lkb1 loss promoted PD-1/PD-L1 inhibitor resistance, suggesting a causal role. Our results identify STK11/LKB1 alterations as a major driver of primary resistance to PD-1 blockade in KRAS-mutant LUAC.Significance: This work identifies STK11/LKB1 alterations as the most prevalent genomic driver of primary resistance to PD-1 axis inhibitors in KRAS-mutant lung adenocarcinoma. Genomic profiling may enhance the predictive utility of PD-L1 expression and tumor mutation burden and facilitate establishment of personalized combination immunotherapy approaches for genomically defined LUAC subsets. Cancer Discov; 8(7); 822-35. ©2018 AACR.See related commentary by Etxeberria et al., p. 794This article is highlighted in the In This Issue feature, p. 781.

Published
2018

16. ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC).

Author

Spigel, David R., primary, Cheng, Ying, additional, Cho, Byoung Chul, additional, Laktionov, Konstantin K., additional, Fang, Jian, additional, Chen, Yuanbin, additional, Zenke, Yoshitaka, additional, Lee, Ki Hyeong, additional, Wang, Qiming, additional, Navarro, Alejandro, additional, Bernabe Caro, Reyes, additional, Buchmeier, Eva Lotte, additional, Chang, John W. C., additional, Okamoto, Isamu, additional, Sezgin Goksu, Sema, additional, Badzio, Andrzej, additional, Gill, Bethany, additional, Gowda, Hema, additional, Jiang, Haiyi, additional, and Senan, Suresh, additional

Published
2024
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17. Updated results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with EC-naïve metastatic BRAF V600E colorectal cancer (CRC) in the phase 1b/2 HERKULES-3 study.

Author

Parikh, Aparna Raj, primary, Chiorean, E. Gabriela, additional, Atreya, Chloe Evelyn, additional, Zheng, Lei, additional, Kopetz, Scott, additional, Spira, Alexander I., additional, Spigel, David R., additional, Cui, Yue, additional, Osgood, Ryan, additional, Tran, Rebecca, additional, Morris, Shannon R., additional, and Ulahannan, Susanna Varkey, additional

Published
2024
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19. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1–Selected NSCLC

Author

Jassem, Jacek, de Marinis, Filippo, Giaccone, Giuseppe, Vergnenegre, Alain, Barrios, Carlos H., Morise, Masahiro, Felip, Enriqueta, Oprean, Cristina, Kim, Young-Chul, Andric, Zoran, Mocci, Simonetta, Enquist, Ida, Komatsubara, Kimberly, McCleland, Mark, Kuriki, Hiroshi, Villalobos, Monette, Phan, See, Spigel, David R., and Herbst, Roy S.

Published
2021
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20. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study

Author

Javle, Milind, Borad, Mitesh J, Azad, Nilofer S, Kurzrock, Razelle, Abou-Alfa, Ghassan K, George, Ben, Hainsworth, John, Meric-Bernstam, Funda, Swanton, Charles, Sweeney, Christopher J, Friedman, Claire F, Bose, Ron, Spigel, David R, Wang, Yong, Levy, Jonathan, Schulze, Katja, Cuchelkar, Vaikunth, Patel, Arisha, and Burris, Howard

Published
2021
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21. Anti–cytotoxic T-lymphocyte–associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer

Author

Cho, Byoung Chul, Yoh, Kiyotaka, Perets, Ruth, Nagrial, Adnan, Spigel, David R., Gutierrez, Martin, Kim, Dong-Wan, Kotasek, Dusan, Rasco, Drew, Niu, Jiaxin, Satouchi, Miyako, Ahn, Myung-Ju, Lee, Dae Ho, Maurice-Dror, Corinne, Siddiqi, Shabana, Ren, Yixin, Altura, Rachel A., and Bar, Jair

Published
2021
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22. Avelumab Versus Docetaxel in Patients With Platinum-Treated Advanced NSCLC: 2-Year Follow-Up From the JAVELIN Lung 200 Phase 3 Trial

Author

Park, Keunchil, Özgüroğlu, Mustafa, Vansteenkiste, Johan, Spigel, David, Yang, James C.H., Ishii, Hidenobu, Garassino, Marina, de Marinis, Filippo, Szczesna, Aleksandra, Polychronis, Andreas, Uslu, Ruchan, Krzakowski, Maciej, Lee, Jong-Seok, Calabrò, Luana, Arén Frontera, Osvaldo, Xiong, Huiling, Bajars, Marcis, Ruisi, Mary, and Barlesi, Fabrice

Published
2021
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23. Prognostic and predictive value of circulating tumor cells and CXCR4 expression as biomarkers for a CXCR4 peptide antagonist in combination with carboplatin-etoposide in small cell lung cancer: exploratory analysis of a phase II study

Author

Salgia, Ravi, Weaver, R Waide, McCleod, Michael, Stille, John R, Yan, S Betty, Roberson, Stephanie, Polzer, John, Flynt, Amy, Raddad, Eyas, Peek, Victoria L, Wijayawardana, Sameera R, Um, Suzane L, Gross, Steve, Connelly, Mark C, Morano, Carrie, Repollet, Madeline, Sanders, Renouard, Baeten, Kurt, D’Haese, David, and Spigel, David R

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Cancer, Clinical Research, Lung Cancer, Lung, 4.1 Discovery and preclinical testing of markers and technologies, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Carboplatin, Cell Count, Disease-Free Survival, Etoposide, Humans, Kaplan-Meier Estimate, Lung Neoplasms, Neoplastic Cells, Circulating, Peptides, Cyclic, Prognosis, Receptors, CXCR4, Small Cell Lung Carcinoma, CXCR4 expression, Carboplatin-etoposide, Circulating tumor cells, LY2510924, Small cell lung cancer, Pharmacology and Pharmaceutical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis, Pharmacology and pharmaceutical sciences
Abstract

Background Circulating tumor cells (CTCs) and chemokine (C-X-C motif) receptor 4 (CXCR4) expression in CTCs and tumor tissue were evaluated as prognostic or predictive markers of CXCR4 peptide antagonist LY2510924 plus carboplatin-etoposide (CE) versus CE in extensive-stage disease small cell lung cancer (ED-SCLC). Methods This exploratory analysis of a phase II study evaluated CXCR4 expression in baseline tumor tissue and peripheral blood CTCs and in post-treatment CTCs. Optimum cutoff values were determined for CTC counts and CXCR4 expression in tumors and CTCs as predictors of survival outcome. Kaplan-Meier estimates and hazard ratios were used to determine biomarker prognostic and predictive values. Results There was weak positive correlation at baseline between CXCR4 expression in tumor tissue and CTCs. Optimum cutoff values were H-score ≥ 210 for CXCR4+ tumor, ≥7% CTCs with CXCR4 expression (CXCR4+ CTCs), and ≥6 CTCs/7.5 mL blood. Baseline H-score for CXCR4+ tumor was not prognostic of progression-free survival (PFS) or overall survival (OS). Baseline CXCR4+ CTCs ≥7% was prognostic of shorter PFS. CTCs ≥6 at baseline and cycle 2, day 1 were prognostic of shorter PFS and OS. None of the biomarkers at their respective optimum cutoffs was predictive of treatment response of LY2510924 plus CE versus CE. Conclusions In patients with ED-SCLC, baseline CXCR4 expression in tumor tissue was not prognostic of survival or predictive of LY2510924 treatment response. Baseline CXCR4+ CTCs ≥7% was prognostic of shorter PFS. CTC count ≥6 at baseline and after 1 cycle of treatment were prognostic of shorter PFS and OS.

Published
2017

24. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial

Author

Gulley, James L, Rajan, Arun, Spigel, David R, Iannotti, Nicholas, Chandler, Jason, Wong, Deborah JL, Leach, Joseph, Edenfield, W Jeff, Wang, Ding, Grote, Hans Juergen, von Heydebreck, Anja, Chin, Kevin, Cuillerot, Jean-Marie, and Kelly, Karen

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Lung Cancer, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Lung, Patient Safety, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Disease Progression, Drug Resistance, Neoplasm, Dyspnea, Fatigue, Female, Humans, Infusions, Intravenous, Lipase, Lung Neoplasms, Male, Middle Aged, Nausea, Neoplasm Recurrence, Local, Platinum Compounds, Pneumonia, Pulmonary Disease, Chronic Obstructive, Response Evaluation Criteria in Solid Tumors, Retreatment, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundAvelumab, a human Ig-G1 monoclonal antibody targeting PD-L1 and approved in the USA for the treatment of metastatic Merkel cell carcinoma, has shown antitumour activity and an acceptable safety profile in patients with advanced solid tumours in a dose-escalation phase 1a trial. In this dose-expansion cohort of that trial, we assess avelumab treatment in a cohort of patients with advanced, platinum-treated non-small-cell lung cancer (NSCLC).MethodsIn this dose-expansion cohort of a multicentre, open-label, phase 1 study, patients with progressive or platinum-resistant metastatic or recurrent NSCLC were enrolled at 58 cancer treatment centres and academic hospitals in the USA. Eligible patients had confirmed stage IIIB or IV NSCLC with squamous or non-squamous histology, measurable disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), tumour biopsy or archival sample for biomarker assessment, and Eastern Cooperative Oncology Group performance status 0 or 1, among other criteria. Patient selection was not based on PD-L1 expression or expression of other biomarkers, including EGFR or KRAS mutation or ALK translocation status. Patients received infusional avelumab monotherapy 10 mg/kg every 2 weeks until disease progression or toxicity. The primary objective was to assess safety and tolerability. This trial is registered with ClinicalTrials.gov, number NCT01772004; enrolment in this cohort is closed and the trial is ongoing.FindingsBetween Sept 10, 2013, and June 24, 2014, 184 patients were enrolled and initiated treatment with avelumab. Median follow-up duration was 8·8 months (IQR 7·2-11·9). The most common treatment-related adverse events of any grade were fatigue (46 [25%] of 184 patients), infusion-related reaction (38 [21%]), and nausea (23 [13%]). Grade 3 or worse treatment-related adverse events occurred in 23 (13%) of 184 patients; the most common (occurring in more than two patients) were infusion-related reaction (four [2%] patients) and increased lipase level (three [2%]). 16 (9%) of 184 patients had a serious adverse event related to treatment with avelumab, with infusion-related reaction (in four [2%] patients) and dyspnoea (in two [1%]) occurring in more than one patient. Serious adverse events irrespective of cause occurred in 80 (44%) of 184 patients. Those occurring in more than five patients (≥3%) were dyspnoea (ten patients [5%]), pneumonia (nine [5%]), and chronic obstructive pulmonary disease (six [3%]). Immune-related treatment-related events occurred in 22 patients (12%). Of 184 patients, 22 (12% [95% CI 8-18]) achieved a confirmed objective response, including one complete response and 21 partial responses. 70 (38%) had stable disease. Overall, 92 (50%) of 184 patients achieved disease control (they had a confirmed response or stable disease as their best overall response). One patient was initially thought to have died from grade 5 radiation pneumonitis during the study; however, this adverse event was subsequently regraded to grade 3 and the death was attributed to disease progression.InterpretationAvelumab showed an acceptable safety profile and antitumour activity in patients with progressive or treatment-resistant NSCLC, providing a rationale for further studies of avelumab in this disease setting.FundingMerck KGaA and Pfizer.

Published
2017

26. Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non–Small-cell Lung Cancer (ABOUND.sqm): A Phase III Randomized Clinical Trial

Author

Spigel, David R., Jotte, Robert M., Aix, Santiago Ponce, Gressot, Laurent, Morgensztern, Daniel, McCleod, Michael, Socinski, Mark A., Daniel, Davey, Juan-Vidal, Oscar, Mileham, Kathryn F., West, Howard, Page, Ray, Reinmuth, Niels, Knoble, Jeanna, Chen, Tianlei, Bhore, Rafia, Wolfsteiner, Marianne, Ong, Teng Jin, Gridelli, Cesare, and Thomas, Michael

Published
2021
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28. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA

Author

Liu, Minetta C., Oxnard, Geoffrey R., Klein, Eric A., Smith, David, Richards, Donald, Yeatman, Timothy J., Cohn, Allen L., Lapham, Rosanna, Clement, Jessica, Parker, Alexander S., Tummala, Mohan K., McIntyre, Kristi, Sekeres, Mikkael A., Bryce, Alan H., Siegel, Robert, Wang, Xuezhong, Cosgrove, David P., Abu-Rustum, Nadeem R., Trent, Jonathan, Thiel, David D., Becerra, Carlos, Agrawal, Manish, Garbo, Lawrence E., Giguere, Jeffrey K., Michels, Ross M., Harris, Ronald P., Richey, Stephen L., McCarthy, Timothy A., Waterhouse, David M., Couch, Fergus J., Wilks, Sharon T., Krie, Amy K., Balaraman, Rama, Restrepo, Alvaro, Meshad, Michael W., Rieger-Christ, Kimberly, Sullivan, Travis, Lee, Christine M., Greenwald, Daniel R., Oh, William, Tsao, Che-Kai, Fleshner, Neil, Kennecke, Hagen F., Khalil, Maged F., Spigel, David R., Manhas, Atisha P., Ulrich, Brian K., Kovoor, Philip A., Stokoe, Christopher, Courtright, Jay G., Yimer, Habte A., Larson, Timothy G., Swanton, Charles, Seiden, Michael V., Cummings, Steven R., Absalan, Farnaz, Alexander, Gregory, Allen, Brian, Amini, Hamed, Aravanis, Alexander M., Bagaria, Siddhartha, Bazargan, Leila, Beausang, John F., Berman, Jennifer, Betts, Craig, Blocker, Alexander, Bredno, Joerg, Calef, Robert, Cann, Gordon, Carter, Jeremy, Chang, Christopher, Chawla, Hemanshi, Chen, Xiaoji, Chien, Tom C., Civello, Daniel, Davydov, Konstantin, Demas, Vasiliki, Desai, Mohini, Dong, Zhao, Fayzullina, Saniya, Fields, Alexander P., Filippova, Darya, Freese, Peter, Fung, Eric T., Gnerre, Sante, Gross, Samuel, Halks-Miller, Meredith, Hall, Megan P., Hartman, Anne-Renee, Hou, Chenlu, Hubbell, Earl, Hunkapiller, Nathan, Jagadeesh, Karthik, Jamshidi, Arash, Jiang, Roger, Jung, Byoungsok, Kim, TaeHyung, Klausner, Richard D., Kurtzman, Kathryn N., Lee, Mark, Lin, Wendy, Lipson, Jafi, Liu, Hai, Liu, Qinwen, Lopatin, Margarita, Maddala, Tara, Maher, M. Cyrus, Melton, Collin, Mich, Andrea, Nautiyal, Shivani, Newman, Jonathan, Newman, Joshua, Nicula, Virgil, Nicolaou, Cosmos, Nikolic, Ongjen, Pan, Wenying, Patel, Shilpen, Prins, Sarah A., Rava, Richard, Ronaghi, Neda, Sakarya, Onur, Satya, Ravi Vijaya, Schellenberger, Jan, Scott, Eric, Sehnert, Amy J., Shaknovich, Rita, Shanmugam, Avinash, Shashidhar, K.C., Shen, Ling, Shenoy, Archana, Shojaee, Seyedmehdi, Singh, Pranav, Steffen, Kristan K., Tang, Susan, Toung, Jonathan M., Valouev, Anton, Venn, Oliver, Williams, Richard T., Wu, Tony, Xu, Hui H., Yakym, Christopher, Yang, Xiao, Yecies, Jessica, Yip, Alexander S., Youngren, Jack, Yue, Jeanne, Zhang, Jingyang, Zhang, Lily, Zhang, Lori (Quan), Zhang, Nan, Curtis, Christina, Berry, Donald A., Liu, M.C., Oxnard, G.R., Klein, E.A., Swanton, C., and Seiden, M.V.

Published
2020
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30. Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Recurrent Small Cell Lung Cancer: Results From the CheckMate 032 Randomized Cohort

Author

Ready, Neal E., Ott, Patrick A., Hellmann, Matthew D., Zugazagoitia, Jon, Hann, Christine L., de Braud, Filippo, Antonia, Scott J., Ascierto, Paolo A., Moreno, Victor, Atmaca, Akin, Salvagni, Stefania, Taylor, Matthew, Amin, Asim, Camidge, D. Ross, Horn, Leora, Calvo, Emiliano, Li, Ang, Lin, Wen Hong, Callahan, Margaret K., and Spigel, David R.

Published
2020
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31. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial

Author

Qiu, Miao-Zhen, primary, Oh, Do-Youn, additional, Kato, Ken, additional, Arkenau, Tobias, additional, Tabernero, Josep, additional, Correa, Marcia Cruz, additional, Zimina, Anastasia V, additional, Bai, Yuxian, additional, Shi, Jianhua, additional, Lee, Keun-Wook, additional, Wang, Jufeng, additional, Poddubskaya, Elena, additional, Pan, Hongming, additional, Rha, Sun Young, additional, Zhang, Ruixing, additional, Hirano, Hidekazu, additional, Spigel, David, additional, Yamaguchi, Kensei, additional, Chao, Yee, additional, Wyrwicz, Lucjan, additional, Disel, Umut, additional, Cid, Roberto Pazo, additional, Fornaro, Lorenzo, additional, Evesque, Ludovic, additional, Wang, Hongwei, additional, Xu, Yaling, additional, Li, Jiang, additional, Sheng, Tao, additional, Yang, Silu, additional, Li, Liyun, additional, Moehler, Markus, additional, and Xu, Rui-Hua, additional

Published
2024
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32. Abstract B112: A dose escalation and cohort expansion study of the CDK9 inhibitor KB-0742 in relapsed, refractory ovarian cancer and transcriptionally addicted relapsed or refractory solid tumors

Author

Villalona-Calero, Miguel, primary, Mita, Monica, additional, Mita, Alain, additional, Federman, Noah, additional, Rasco, Drew, additional, Spigel, David, additional, Luo, Jia, additional, Cote, Gregory M., additional, Cutler, Richard E., additional, Kumar, Pavan, additional, MacKenzie, Crystal J., additional, Lin, Charles, additional, DiMartino, Jorge F., additional, Olek, Elizabeth A., additional, and Van Tine, Brian, additional

Published
2024
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33. Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial

Author

Lenz, Heinz-Josef, primary, Parikh, Aparna, additional, Spigel, David R, additional, Cohn, Allen L, additional, Yoshino, Takayuki, additional, Kochenderfer, Mark, additional, Elez, Elena, additional, Shao, Spencer H, additional, Deming, Dustin, additional, Holdridge, Regan, additional, Larson, Timothy, additional, Chen, Eric, additional, Mahipal, Amit, additional, Ucar, Antonio, additional, Cullen, Dana, additional, Baskin-Bey, Edwina, additional, Kang, Tong, additional, Hammell, Amy B, additional, Yao, Jin, additional, and Tabernero, Josep, additional

Published
2024
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34. Randomized Phase II Study of Paclitaxel plus Alisertib versus Paclitaxel plus Placebo as Second-Line Therapy for SCLC: Primary and Correlative Biomarker Analyses

Author

Owonikoko, Taofeek K., Niu, Huifeng, Nackaerts, Kristiaan, Csoszi, Tibor, Ostoros, Gyula, Mark, Zsuzsanna, Baik, Christina, Joy, Anil Abraham, Chouaid, Christos, Jaime, Jesus Corral, Kolek, Vitezslav, Majem, Margarita, Roubec, Jaromir, Santos, Edgardo S., Chiang, Anne C., Speranza, Giovanna, Belani, Chandra P., Chiappori, Alberto, Patel, Manish R., Czebe, Krisztina, Byers, Lauren, Bahamon, Brittany, Li, Cong, Sheldon-Waniga, Emily, Kong, Eric F., Williams, Miguel, Badola, Sunita, Shin, Hyunjin, Bedford, Lisa, Ecsedy, Jeffrey A., Bryant, Matthew, Jones, Sian, Simmons, John, Leonard, E. Jane, Ullmann, Claudio Dansky, and Spigel, David R.

Published
2020
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36. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non–Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial

Author

Kelly, Karen, Altorki, Nasser K, Eberhardt, Wilfried EE, O'Brien, Mary ER, Spigel, David R, Crinò, Lucio, Tsai, Chun-Ming, Kim, Joo-Hang, Cho, Eun Kyung, Hoffman, Philip C, Orlov, Sergey V, Serwatowski, Piotr, Wang, Jiuzhou, Foley, Margaret A, Horan, Julie D, and Shepherd, Frances A

Subjects
Cancer, Lung Cancer, Prevention, Clinical Trials and Supportive Activities, Lung, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Chemotherapy, Adjuvant, Double-Blind Method, ErbB Receptors, Erlotinib Hydrochloride, Female, Follow-Up Studies, Humans, International Agencies, Lung Neoplasms, Male, Middle Aged, Mutation, Neoplasm Staging, Prognosis, Survival Rate, Young Adult, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeEpidermal growth factor receptor (EGFR) -tyrosine kinase inhibitors have proven efficacy in advanced non-small-cell lung cancer (NSCLC). We hypothesized that erlotinib would be efficacious in the adjuvant setting.Patients and methodsAn international randomized, double-blind, placebo-controlled study was conducted in patients with completely resected IB to IIIA NSCLC whose tumors expressed EGFR protein by immunohistochemistry or EGFR amplification by fluorescence in situ hybridization. Patients were assigned 2:1 to erlotinib 150 mg once per day or placebo for 2 years. Stratification factors were stage, histology, previous adjuvant chemotherapy, smoking status, EGFR amplification status, and country. The primary end point was disease-free survival (DFS); key secondary end points were overall survival (OS) and DFS and OS in patients whose tumors had EGFR-activating mutations (EGFRm-positive).ResultsA total of 973 patients were randomly assigned (November 26, 2007, to July 7, 2010). There was no statistically significant difference in DFS (median, 50.5 months for erlotinib and 48.2 months for placebo; hazard ratio, 0.90; 95% CI, 0.74 to 1.10; P = .324). Among the 161 patients (16.5%) in the EGFRm-positive subgroup, DFS favored erlotinib (median, 46.4 v 28.5 months; hazard ratio, 0.61; 95% CI, 0.38 to 0.98; P = .039), but this was not statistically significant because of the hierarchical testing procedure. OS data are immature. Rash and diarrhea were common adverse events occurring in 528 (86.4%) and 319 (52.2%) patients treated with erlotinib, respectively, versus 110 (32.1%) and 54 (15.7%) patients receiving placebo. The most common grade 3 adverse events in patients treated with erlotinib were rash (22.3%) and diarrhea (6.2%).ConclusionAdjuvant erlotinib did not prolong DFS in patients with EGFR-expressing NSCLC or in the EGFRm-positive subgroup. Further evaluation of erlotinib is warranted in the EGFRm-positive subgroup.

Published
2015

37. Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial

Author

Batagelj, Emilio, Casarini, Ignacio, Pastor, Anea Viviana, Sena, Susana Noemi, Zarba, Juan Jose, Burghuber, Otto, Hartl, Sylvia, Hochmair, Maximilian J, Lamprecht, Bernd, Studnicka, Michael, Alberto Schlittler, Luis, Augusto Martinelli de Oliveira, Fabricio, Calabrich, Aknar, Colagiovanni Girotto, Gustavo, Dos Reis, Peo, Fausto Nino Gorini, Carlos, Rafael Martins De Marchi, Peo, Serodio da Rocha Baldotto, Clarissa, Sette, Claudia, Zukin, Mauro, Conev, Nikolay V, Dudov, Assen, Ilieva, Rumyana, Koynov, Krassimir, Krasteva, Rositsa, Tonev, Ivan, Valev, Spartak, Venkova, Violetka, Bi, Minghong, Chen, Chengshui, Chen, Yuan, Chen, Zhendong, Fang, Jian, Feng, Jifeng, Han, Zhigang, Hu, Jie, Hu, Yi, Li, Wei, Liang, Zongan, Lin, Zhong, Ma, Rui, Ma, Shenglin, Nan, Kejun, Shu, Yongqian, Wang, Kai, Wang, Mengzhao, Wu, Gang, Yang, Nong, Yang, Zhixiong, Zhang, Helong, Zhang, Wei, Zhao, Jun, Zhao, Yanqiu, Zhou, Caicun, Zhou, Jianying, Zhou, Xiangdong, Havel, Libor, Kolek, Vitezslav, Koubkova, Leona, Roubec, Jaromir, Skrickova, Jana, Zemanova, Milada, Chouaid, Christos, Hilgers, Werner, Lena, Hervé, Moro-Sibilot, Denis, Robinet, Gilles, Souquet, Pierre-Jean, Alt, Jürgen, Bischoff, Helge, Grohe, Christian, Laack, Eckart, Lang, Susanne, Panse, Jens, Reinmuth, Niels, Schulz, Christian, Bogos, Krisztina, Csánky, Eszter, Fülöp, Anea, Horváth, Zsolt, Kósa, Judit, Laczó, Ibolya, Losonczy, György, Pajkos, Gábor, Pápai, Zsuzsanna, Pápai Székely, Zsolt, Sárosi, Veronika, Somfay, Attila, Somogyiné Ezer, Éva, Telekes, Anás, Bar, Jair, Gottfried, Maya, Heching, Norman Isaac, Zer Kuch, Alona, Bartolucci, Roberta, Bettini, Anna Cecilia, Delmonte, Angelo, Garassino, Marina Chiara, Minelli, Mauro, Roila, Fausto, Verderame, Francesco, Atagi, Shinji, Azuma, Koichi, Goto, Hisatsugu, Goto, Koichi, Hara, Yu, Hayashi, Hidetoshi, Hida, Toyoaki, Hotta, Katsuyuki, Kanazawa, Kenya, Kanda, Shintaro, Kim, Young Hak, Kuyama, Shoichi, Maeda, Tadashi, Morise, Masahiro, Nakahara, Yasuharu, Nishio, Makoto, Nogami, Naoyuki, Okamoto, Isamu, Saito, Haruhiro, Shinoda, Masahiro, Umemura, Shigeki, Yoshida, Tatsuya, Claessens, Niels, Cornelissen, Robin, Heniks, Lizza, Hiltermann, Jeroen, Smit, Egbert, Staal van den Brekel, Agnes, Kazarnowicz, Andrzej, Kowalski, Dariusz, Mańdziuk, Slawomir, Mróz, Robert, Wojtukiewicz, Marek, Ciuleanu, Tudor, Ganea, Doina, Ungureanu, Anei, Dvorkin, Mikhail, Luft, Alexander, Moiseenko, Vladimir, Poltoratskiy, Artem, Sakaeva, Dina, Smolin, Alexey, Statsenko, Galina, Vasilyev, Alexander, Vladimirova, Lyubov, Anasina, Igor, Chovanec, Jozef, Demo, Pavol, Godal, Robert, Kasan, Peter, Stresko, Marian, Urda, Michal, Cho, Eun Kyung, Ji, Jun Ho, Kim, Joo-Hang, Kim, Sang-We, Lee, Gyeong-Won, Lee, Jong-Seok, Lee, Ki Hyeong, Lee, Kyung Hee, Lee, Yun Gyoo, Amelia Insa Molla, Maria, Domine Gomez, Manuel, Ignacio Delgado Mingorance, Juan, Isla Casado, Dolores, Lopez Brea, Marta, Majem Tarruella, Margarita, Morán Bueno, Teresa, Navarro Mendivil, Alejano, Paz-Ares Rodríguez, Luis, Ponce Aix, Santiago, Rosario Garcia Campelo, Maria, Chang, Gee-Chen, Chen, Yen-Hsun, Chiu, Chao-Hua, Hsia, Te-Chun, Lee, Kang-Yun, Li, Chien-Te, Wang, Chin-Chou, Wei, Yu-Feng, Wu, Shang-Yin, Alacacıoğlu, Ahmet, Çiçin, Irfan, Demirkazik, Ahmet, Erman, Mustafa, Göksel, Tuncay, Özgüroğlu, Mustafa, Adamchuk, Hryhoriy, Bondarenko, Igor, Kolesnik, Oleksii, Kryzhanivska, Anna, Ostapenko, Yuriv, Shevnia, Serhii, Shparyk, Yaroslav, Trukhin, Dmytro, Ursol, Grygorii, Voitko, Nataliia, Voitko, Oleksandr, Vynnychenko, Ihor, Babu, Sunil, Chen, Yuanbin, Chiang, Anne, Chua, Winston, Dakhil, Shaker, Dowlati, Afshin, Goldman, Jonathan W, Haque, Basir, Jamil, Rodney, Knoble, Jeanna, Lakhanpal, Shailena, Mi, Kailhong, Nikolinakos, Petros, Powell, Steven, Ross, Helen, Schaefer, Eric, Schneider, Jeffrey, Spahr, Joseph, Spigel, David, Stilwill, Joseph, Sumey, Christopher, Williamson, Michael, Paz-Ares, Luis, Ponce, Santiago, Armstrong, Jon, Byrne, Natalie, Shire, Norah, and Jiang, Haiyi

Published
2019
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38. Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non–Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153)

Author

Spigel, David R., McCleod, Michael, Jotte, Robert M., Einhorn, Lawrence, Horn, Leora, Waterhouse, David M., Creelan, Ben, Babu, Sunil, Leighl, Natasha B., Chandler, Jason C., Couture, Felix, Keogh, George, Goss, Glenwood, Daniel, Davey B., Garon, Edward B., Schwartzberg, Lee S., Sen, Rohini, Korytowsky, Beata, Li, Ang, Aanur, Nivedita, and Hussein, Maen A.

Published
2019
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39. Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study

Author

Meric-Bernstam, Funda, Hurwitz, Herbert, Raghav, Kanwal Pratap Singh, McWilliams, Robert R, Fakih, Marwan, VanderWalde, Ari, Swanton, Charles, Kurzrock, Razelle, Burris, Howard, Sweeney, Christopher, Bose, Ron, Spigel, David R, Beattie, Mary S, Blotner, Steven, Stone, Alyssa, Schulze, Katja, Cuchelkar, Vaikunth, and Hainsworth, John

Published
2019
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40. Therapy for Stage IV Non–Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2023.3

Author

Jaiyesimi, Ishmael A., primary, Leighl, Natasha B., additional, Ismaila, Nofisat, additional, Alluri, Krishna, additional, Florez, Narjust, additional, Gadgeel, Shirish, additional, Masters, Gregory, additional, Schenk, Erin L., additional, Schneider, Bryan J., additional, Sequist, Lecia, additional, Singh, Navneet, additional, Bazhenova, Lyudmila, additional, Blanchard, Elizabeth, additional, Freeman-Daily, Janet, additional, Furuya, Naoki, additional, Halmos, Balazs, additional, Azar, Ibrahim Hanna, additional, Kuruvilla, Sara, additional, Mullane, Michael, additional, Naidoo, Jarushka, additional, Reuss, Joshua E., additional, Spigel, David R., additional, Owen, Dwight H., additional, and Patel, Jyoti D., additional

Published
2024
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41. Tislelizumab plus chemotherapy (chemo) versus placebo plus chemo as first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: RATIONALE-305 European/North American patient subgroup.

Author

Arkenau, Hendrik-Tobias, primary, Tabernero, Josep, additional, Cruz-Correa, Marcia, additional, Zimina, Anastasia V., additional, Poddubskaya, Elena, additional, Moiseenko, Fedor Vladimirovich, additional, Spigel, David R., additional, Wyrwicz, Lucjan S., additional, Disel, Umut, additional, Pazo Cid, Roberto, additional, Cubillo Gracian, Antonio, additional, Alés Diaz, Inmaculada, additional, Fornaro, Lorenzo, additional, Evesque, Ludovic, additional, Xu, Yaling, additional, Sheng, Tao, additional, Yang, Silu, additional, Li, Liyun, additional, Moehler, Markus H., additional, and Xu, Rui-Hua, additional

Published
2024
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42. Tislelizumab (TIS) plus chemotherapy (Chemo) vs placebo (PBO) plus chemo as first-line (1L) treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC): Health-related quality of life (HRQoL) outcomes in the RATIONALE-305 study.

Author

Cruz-Correa, Marcia, primary, Xu, Rui-Hua, additional, Moehler, Markus H., additional, Oh, Do-Youn, additional, Kato, Ken, additional, Spigel, David R., additional, Arkenau, Hendrik-Tobias, additional, Tabernero, Josep, additional, Zimina, Anastasia V., additional, Bai, Yuxian, additional, Shi, Jianhua, additional, Lee, Keun-Wook, additional, Hirano, Hidekazu, additional, Wyrwicz, Lucjan S., additional, Pazo Cid, Roberto, additional, Xu, Hui, additional, Sheng, Tao, additional, and Barnes, Gisoo, additional

Published
2024
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43. MyPathway Human Epidermal Growth Factor Receptor 2 Basket Study: Pertuzumab + Trastuzumab Treatment of a Tissue-Agnostic Cohort of Patients With Human Epidermal Growth Factor Receptor 2–Altered Advanced Solid Tumors

Author

Sweeney, Christopher J., primary, Hainsworth, John D., additional, Bose, Ron, additional, Burris, Howard A., additional, Kurzrock, Razelle, additional, Swanton, Charles, additional, Friedman, Claire F., additional, Spigel, David R., additional, Szado, Tania, additional, Schulze, Katja, additional, Price, Richard, additional, Malato, Julia, additional, Lo, Amy A., additional, Levy, Jonathan, additional, Wang, Yong, additional, Yu, Wei, additional, and Meric-Bernstam, Funda, additional

Published
2024
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46. Differential regulation of PD-L1 expression by immune and tumor cells in NSCLC and the response to treatment with atezolizumab (anti–PD-L1)

Author

Kowanetz, Marcin, Zou, Wei, Gettinger, Scott N., Koeppen, Hartmut, Kockx, Mark, Schmid, Peter, Kadel, Edward E., Wistuba, Ignacio, Chaft, Jamie, Rizvi, Naiyer A., Spigel, David R., Spira, Alexander, Hirsch, Fred R., Cohen, Victor, Smith, Dustin, Boyd, Zach, Miley, Natasha, Flynn, Susan, Leveque, Vincent, Shames, David S., Ballinger, Marcus, Mocci, Simonetta, Shankar, Geetha, Funke, Roel, Hampton, Garret, Sandler, Alan, Amler, Lukas, Mellman, Ira, Chen, Daniel S., and Hegde, Priti S.

Published
2018

48. Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study

Author

Barlesi, Fabrice, Vansteenkiste, Johan, Spigel, David, Ishii, Hidenobu, Garassino, Marina, de Marinis, Filippo, Özgüroğlu, Mustafa, Szczesna, Aleksandra, Polychronis, Andreas, Uslu, Ruchan, Krzakowski, Maciej, Lee, Jong-Seok, Calabrò, Luana, Arén Frontera, Osvaldo, Ellers-Lenz, Barbara, Bajars, Marcis, Ruisi, Mary, and Park, Keunchil

Published
2018
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50. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study

Author

Horn, Leora, Gettinger, Scott N., Gordon, Michael S., Herbst, Roy S., Gandhi, Leena, Felip, Enriqueta, Sequist, Lecia V., Spigel, David R., Antonia, Scott J., Balmanoukian, Ani, Cassier, Philippe A., Liu, Bo, Kowanetz, Marcin, O'Hear, Carol, Fassò, Marcella, Grossman, William, Sandler, Alan, and Soria, Jean-Charles

Published
2018
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