Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03516981 · ClinicalTrials.gov registry record · Phase 2
A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 245
- Enrollment target
NCT03516981: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT03516981 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 245 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03516981, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 245 participants
- Enrollment target
Study Summary
This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile \[GEP\] and tumor mutational burden \[TMB\]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.
Primary Outcome
ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by local site radiologic review. The percentage of participants who experience CR or PR as assessed by local site radiologic review with confir
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Lenvatinib
- BIOLOGICAL Favezelimab
- DRUG Quavonlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2025-06-13 |
| Phase | Phase 2 |
What the finished NCT03516981 record still lists
NCT03516981 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% higher).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03516981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03516981 about?
NCT03516981 is a clinical study titled "A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)". This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile \[GEP\] and tumor mutational bur...
What is the current status of trial NCT03516981?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2018-10-01. Estimated completion is 2025-06-13.
What interventions are being tested in trial NCT03516981?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lenvatinib (DRUG), Favezelimab (BIOLOGICAL), Quavonlimab (DRUG).
Who is sponsoring clinical trial NCT03516981?
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 NCT03516981's enrollment target sits among peer trials
245 234th of 2000 higher than 1,766 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03645928 · 245 participants · Phase 2
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
- NCT04718168 · 245 participants · NA
GORE® ENFORM Biomaterial Product Study
- NCT05145127 · 245 participants · Phase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
- NCT05446259 · 245 participants
Degenerative Cervical Myelopathy Repository
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI