Shakun M. Malik

Adjuvant Nivolumab vs Observation in Resected Non–Small Cell Lung Cancer

Jamie E. Chaft, Zhuoxin Sun, Charles M. Rudin, Onkar Khullar et autres

Importance: Preoperative and perioperative nivolumab improve event-free survival in resectable non-small cell lung cancer. The role of adjuvant nivolumab after upfront surgery is unknown. Objective: To determine whether adjuvant nivolumab improves disease-free survival and overall survival in patients with resected non-small cell …

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Adjuvant erlotinib versus observation after complete resection of EGFR -mutant NSCLC: Final overall survival results of Alliance A081105.

Ramaswamy Govindan, Sumithra J. Mandrekar, David E. Kozono, Jamie E. Chaft et autres

8001 Background: The ALCHEMIST clinical trial platform, launched by the National Clinical Trials Network (NCTN) in 2014, screened patients with resected non-small cell lung cancer (NSCLC) for molecular markers and tailored post-operative adjuvant therapy trials. A081105 evaluated whether adjuvant erlotinib improved overall …

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Randomized phase III study of nivolumab after surgery and adjuvant chemotherapy in NSCLC (ECOG-ACRIN EA5142, ALCHEMIST).

Jamie E. Chaft, Zhuoxin Sun, Charles M. Rudin, Charles B. Simone et autres

8000 Background: The NCI’s ALCHEMIST program has screened thousands of patients with resected lung adenocarcinoma for mutations in EGFR and ALK. EA5142 studied the efficacy of adjuvant nivolumab after standard of care adjuvant therapy in patients with resected lung adenocarcinoma without sensitizing …

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Differences in central versus local lab PD-L1 classification in the ALCHEMIST Alliance A151216 non–small cell lung cancer (NSCLC) study.

David E. Kozono, Sharmila Giri, Shauna L. Hillman, Meghana Nair et autres

8057 Background: The NCI Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST) study tested resected stage II-IIIB(N2) NSCLC for targetable EGFR and ALK alterations and PD-L1 expression to screen patients for biomarker-driven adjuvant therapy trials (NCT02194738). Local lab results were …

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PL02.18 Phase 3 Trial of Crizotinib vs Observation for Surgically Resected Early-Stage ALK+ NSCLC

David E. Gerber, Y. Wang, Corey Jay Langer, Onkar V. Khullar et autres

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Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP)

Riha Vaidya, Joseph M. Unger, Qian Lu, Katherine Minichiello et autres

PURPOSE Lung Cancer Master Protocol (Lung-MAP), a public-private partnership, established infrastructure for conducting a biomarker-driven master protocol in molecularly targeted therapies. We compared characteristics of patients enrolled in Lung-MAP with those of patients in advanced non–small-cell lung cancer (NSCLC) trials to examine …

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Supplementary Data from Adding Base-Excision Repair Inhibitor TRC102 to Standard Pemetrexed–Platinum–Radiation in Patients with Advanced Nonsquamous Non–Small Cell Lung Cancer: Results of a Phase I Trial

Tithi Biswas, Afshin Dowlati, Charles A. Kunos, John J. Pink et autres

Supplementary Data from Adding Base-Excision Repair Inhibitor TRC102 to Standard Pemetrexed–Platinum–Radiation in Patients with Advanced Nonsquamous Non–Small Cell Lung Cancer: Results of a Phase I Trial

Data from Adding Base-Excision Repair Inhibitor TRC102 to Standard Pemetrexed–Platinum–Radiation in Patients with Advanced Nonsquamous Non–Small Cell Lung Cancer: Results of a Phase I Trial

Tithi Biswas, Afshin Dowlati, Charles A. Kunos, John J. Pink et autres

AbstractPurpose: TRC102, a small-molecule base-excision repair inhibitor, potentiates the cytotoxicity of pemetrexed and reverses resistance by binding to chemotherapy-induced abasic sites in DNA. We conducted a phase I clinical trial combining pemetrexed and TRC102 with cisplatin–radiation in stage III nonsquamous non–small cell …

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Data from Adding Base-Excision Repair Inhibitor TRC102 to Standard Pemetrexed–Platinum–Radiation in Patients with Advanced Nonsquamous Non–Small Cell Lung Cancer: Results of a Phase I Trial

Tithi Biswas, Afshin Dowlati, Charles A. Kunos, John J. Pink et autres

AbstractPurpose: TRC102, a small-molecule base-excision repair inhibitor, potentiates the cytotoxicity of pemetrexed and reverses resistance by binding to chemotherapy-induced abasic sites in DNA. We conducted a phase I clinical trial combining pemetrexed and TRC102 with cisplatin–radiation in stage III nonsquamous non–small cell …

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Supplementary Data from Adding Base-Excision Repair Inhibitor TRC102 to Standard Pemetrexed–Platinum–Radiation in Patients with Advanced Nonsquamous Non–Small Cell Lung Cancer: Results of a Phase I Trial

Tithi Biswas, Afshin Dowlati, Charles A. Kunos, John J. Pink et autres

Supplementary Data from Adding Base-Excision Repair Inhibitor TRC102 to Standard Pemetrexed–Platinum–Radiation in Patients with Advanced Nonsquamous Non–Small Cell Lung Cancer: Results of a Phase I Trial

Clinical Trial Development in TP53-Mutated Locally Advanced and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Cristina P. Rodriguez, Hyunseok Kang, Jessica Lyn Geiger, Barbara Ann Burtness et autres

TP53 mutation is the most frequent genetic event in head and neck squamous cell carcinoma (HNSCC), found in more than 80% of patients with human papillomavirus-negative disease. As mutations in the TP53 gene are associated with worse outcomes in HNSCC, novel therapeutic …

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Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP).

Riha Vaidya, Joseph M. Unger, Qian Lü, Katherine Minichiello et autres

6543 Background: A major goal of Lung-MAP, a biomarker-driven master protocol conducted within the National Clinical Trials Network of the NCI using a public-private partnership, was to improve access to novel therapeutics. Representative enrollment of patient sub-groups in clinical trials is essential …

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