Editing Trials (National Cancer Institute)

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'''NCTID''': NCT03425643 
 '''Title''': Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671) 
 '''Study Summary''': This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery <math display="block">neoadjuvant phase</math>, followed by pembrolizumab alone after surgery <math display="block">adjuvant phase</math> in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2018-04-24 
 '''Last Updated''': 2023-11-13 
 '''Number of Patients''': 797 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Non-small Cell Lung Cancer 
'''NCTID''': NCT04624204 
 '''Title''': Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) 
 '''Study Summary''': The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).  Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.  Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.  Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.  Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 200 mg 
 '''Start Date''': 2020-12-08 
 '''Last Updated''': 2023-11-28 
 '''Number of Patients''': 672 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Small Cell Lung Cancer 
'''NCTID''': NCT03221426 
 '''Title''': Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) 
 '''Study Summary''': The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.  The primary study hypotheses are that:  * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2017-10-09 
 '''Last Updated''': 2023-09-22 
 '''Number of Patients''': 1007 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Gastric Cancer 
'''NCTID''': NCT00915018 
 '''Title''': Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer 
 '''Study Summary''': This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen. 
 '''Sponsor''': Puma Biotechnology, Inc. 
 '''Intervention''': Neratinib 
 '''Start Date''': 2009-08-21 
 '''Last Updated''': 2018-08-22 
 '''Number of Patients''': 479 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT05052801 
 '''Title''': Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression 
 '''Study Summary''': The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC) 
 '''Sponsor''': Amgen 
 '''Intervention''': Bemarituzumab 
 '''Start Date''': 2022-03-07 
 '''Last Updated''': 2023-11-27 
 '''Number of Patients''': 516 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Gastric Cancer 
'''NCTID''': NCT04456699 
 '''Title''': Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003) 
 '''Study Summary''': This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Olaparib 
 '''Start Date''': 2020-08-19 
 '''Last Updated''': 2023-10-19 
 '''Number of Patients''': 335 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Metastatic Colorectal Cancer