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NCT05800015 · ClinicalTrials.gov registry record · Phase 2
A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 950
- Enrollment target
- 20
- Study locations
NCT05800015: Active Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Regeneron Pharmaceuticals.
NCT05800015 is a Phase 2 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 950 participants, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05800015, a Phase 2 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 950 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each study drug is in your blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) * How administering the study drugs might improve your quality of life
Primary Outcome
Phase 2 ORR is defined as proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR).
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Paclitaxel
- DRUG fianlimab
- DRUG cemiplimab
Study Locations (20)
California
- The Oncology Institute of Hope & Innovation - Cerritos
- Crosson Cancer Institute - Fullerton
- St. Joseph Hospital Orange - Orange
- Desert Hematology Oncology Medical Group Incorporated - Rancho Mirage
- Emad Ibrahim, MD, Inc. - Redlands
- PIH Health Hospital - Whittier
Florida
- Clermont Oncology Center - Clermont
- Miami Veterans Administration HealthCare System - Miami
- Mid Florida Hematology and Oncology Center - Orange City
- Tallahassee Memorial Healthcare - Tallahassee
Arizona
- Arizona Clinical Research Center - Tucson
- Yuma Regional Medical Center - Yuma
Illinois
- University of Illinois - Chicago
- Northwest Oncology and Hematology - Rolling Meadows
Colorado
- Rocky Mountain Regional VA Medical Center - Aurora
Connecticut
- Yale Cancer Center - New Haven
Louisiana
- Mary Bird Perkins Cancer Center - Baton Rouge
Mississippi
- Hattiesburg Clinic - Hattiesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 950 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2031-12-23 |
| Phase | Phase 2 |
What the registry record for NCT05800015 still lists
NCT05800015 is an interventional study that assigns participants to a tested intervention. The registered 950 participants enrollment target is mid-sized for trials with a published cap, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (46% higher).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05800015 names 20 study sites across 10 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05800015 about?
NCT05800015 is a clinical study titled "A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer". This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outsid...
What is the current status of trial NCT05800015?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 950 participants. The study started on 2023-08-08. Estimated completion is 2031-12-23.
What conditions does trial NCT05800015 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT05800015?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Paclitaxel (DRUG), fianlimab (DRUG), cemiplimab (DRUG).
Who is sponsoring clinical trial NCT05800015?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05800015 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05800015's enrollment target sits among peer trials
950 24th of 454 higher than 431 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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.
Source ClinicalTrials.gov registry export · 2026-08-08
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