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Monoclonal Antibodies

Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Must not have
History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
Active or untreated brain metastases or spinal cord compression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 32 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new cancer treatment involving an immunotherapy drug and chemo for patients with NSCLC. The objective is to improve overall survival and compare it to standard chemo treatment.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) who haven't had systemic treatment for metastatic or recurrent disease. Participants must have a performance status indicating they can care for themselves and an expected lifespan of at least 3 months. They should not be candidates for chemoradiation, have measurable lesions, and specifically in Part 1, less than 50% PD-L1 tumor expression.
What is being tested?
The study tests combinations of Cemiplimab (an anti-PD-1 antibody) with chemotherapy against platinum-based doublet chemotherapy alone. It aims to see if these combinations improve overall survival and slow down the progression of NSCLC compared to standard chemo, considering different levels of PD-L1 expression in tumors.
What are the potential side effects?
Potential side effects include immune system reactions that may cause inflammation in various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue, digestive issues like nausea or diarrhea, blood disorders such as anemia or clotting problems, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stage IIIB, IIIC, or IV NSCLC and haven't had specific treatments for it.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had lung conditions like fibrosis or inflammation in the past 5 years.
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I have active or untreated brain or spinal cord cancer spread.
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My tumor is positive for EGFR, ALK, or ROS1.
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I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 32 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of Dose-limiting toxicities (DLTs)
Quality of life as measured by EORTC QLQ-C30
Quality of life as measured by EORTC QLQ-LC13

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Group I: REGN2810+Chemo Part 2Experimental Treatment1 Intervention
Part 2: REGN2810+chemo
Group II: REGN2810+Chemo Part 1Experimental Treatment1 Intervention
Part 1: REGN2810+chemo
Group III: REGN2810+AbbrevChemo+ipiExperimental Treatment1 Intervention
Part 1: REGN2810+abbrev chemo+ipi
Group IV: Placebo+ChemoExperimental Treatment1 Intervention
Part 2: Placebo plus chemo
Group V: ChemoExperimental Treatment2 Interventions
Part 1: Chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REGN2810
2017
Completed Phase 1
~80
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

SanofiIndustry Sponsor
2,216 Previous Clinical Trials
4,046,842 Total Patients Enrolled
Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,034 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,127 Total Patients Enrolled

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03409614 — Phase 3
Lung Cancer Research Study Groups: REGN2810+Chemo Part 1, REGN2810+AbbrevChemo+ipi, Placebo+Chemo, REGN2810+Chemo Part 2, Chemo
Lung Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT03409614 — Phase 3
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03409614 — Phase 3
~10 spots leftby Feb 2025
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