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NCT03066778 · ClinicalTrials.gov registry record · Phase 3
A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 453
- Enrollment target
NCT03066778 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 453 participants.
The verdict
NCT03066778, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 453 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum \[EP\]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy. The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Etoposide
- DRUG Normal saline solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2017-05-02 |
| Est. Completion | 2021-09-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03066778
The ClinicalTrials.gov registry entry for NCT03066778 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 453 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03066778 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03066778 about?
NCT03066778 is a clinical study titled "A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)". The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum \[EP\]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malign...
What is the current status of trial NCT03066778?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2017-05-02. Estimated completion is 2021-09-21.
What interventions are being tested in trial NCT03066778?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Normal saline solution (DRUG).
Who is sponsoring clinical trial NCT03066778?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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