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NCT03664024 · ClinicalTrials.gov registry record · Phase 2
Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT03664024: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT03664024 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03664024, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
Participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) without prior systemic treatment will be treated with standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The platinum doublet would be pemetrexed plus the investigator's choice of either cisplatin or carboplatin. The primary objective is to evaluate if total baseline tumor mutation burden (TMB) in cell-free circulating tumor deoxyribonucleic acid (ctDNA) is predictive of objective response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by the investigator by estimating the level of association.
Primary Outcome
Objective response rate is the proportion of participants who have a confirmed complete response (CR) or partial response (PR). Objective response rate is assessed by investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2018-10-30 |
| Est. Completion | 2021-11-05 |
| Phase | Phase 2 |
What the finished NCT03664024 record still lists
NCT03664024 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03664024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03664024 about?
NCT03664024 is a clinical study titled "Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782)". Participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) without prior systemic treatment will be treated with standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The ...
What is the current status of trial NCT03664024?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2018-10-30. Estimated completion is 2021-11-05.
What interventions are being tested in trial NCT03664024?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG).
Who is sponsoring clinical trial NCT03664024?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03664024's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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