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NCT03515837 · ClinicalTrials.gov registry record · Phase 3
Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 492
- Enrollment target
- 20
- Study locations
NCT03515837: Completed Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
NCT03515837 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 492 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03515837, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 492 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib \[TAGRISSO®\] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.
Primary Outcome
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS was assessed by blinded independent central review (BICR) using RECIST 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also cons
Conditions Studied
Interventions
- BIOLOGICAL pembrolizumab
- DRUG cisplatin
- DRUG carboplatin
- DRUG pemetrexed
- DRUG saline solution
Study Locations (20)
California
- Cedars-Sinai Medical Center ( Site 0070) - Los Angeles
- Pacific Cancer Care ( Site 0058) - Monterey
- UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092) - Orange
- St. Joseph Heritage Healthcare ( Site 0003) - Santa Rosa
New York
- New York Oncology Hematology P.C ( Site 8000) - Albany
- Monter Cancer Center ( Site 0054) - Lake Success
- Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049) - New York
- White Plains Hospital Center for Cancer Care ( Site 0014) - White Plains
Oregon
- Providence Portland Medical Center ( Site 0097) - Portland
- Kaiser Permanente Northwest ( Site 0037) - Portland
Texas
- Parkland Health & Hospital System ( Site 2102) - Dallas
- University of Texas Southwestern Medical Center at Dallas ( Site 0035) - Dallas
Illinois
- North Shore University Health System ( Site 0030) - Evanston
Iowa
- Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065) - Sioux City
Minnesota
- Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048) - Edina
Missouri
- Saint Lukes Hospital of Kansas City ( Site 0060) - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 492 participants |
| Start Date | 2018-06-29 |
| Est. Completion | 2023-10-02 |
| Phase | Phase 3 |
What the finished NCT03515837 record still lists
NCT03515837 is an interventional study that assigns participants to a tested intervention. The registered 492 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which pembrolizumab is the first listed.
NCT03515837 names 20 study sites across 12 states, led by California, New York, Oregon.
Frequently Asked Questions
What is clinical trial NCT03515837 about?
NCT03515837 is a clinical study titled "Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)". The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth f...
What is the current status of trial NCT03515837?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 492 participants. The study started on 2018-06-29. Estimated completion is 2023-10-02.
What conditions does trial NCT03515837 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT03515837?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), cisplatin (DRUG), carboplatin (DRUG), pemetrexed (DRUG), saline solution (DRUG).
Who is sponsoring clinical trial NCT03515837?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03515837 being conducted?
This trial has 20 study locations across California, Illinois, Iowa, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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