Fianlimab + Cemiplimab for Non-Small Cell Lung Cancer

Phase 2 & 3

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new drug combination for patients with advanced lung cancer. It aims to see if using two drugs together is more effective than one alone. The study also looks at side effects, how the drugs are processed in the body, and their impact on quality of life.

Who is the study for?

Adults with advanced non-small cell lung cancer (NSCLC) who haven't had prior treatments for metastatic disease, have high PD-L1 levels (≥50%), and can provide a tumor tissue sample. They should have at least one measurable lesion, good organ function, and an ECOG performance status of ≤1. Excluded are those needing significant steroid treatment recently, with certain immune conditions or untreated brain metastases.

What is being tested?

The trial is testing the effectiveness of fianlimab combined with cemiplimab versus cemiplimab alone in treating NSCLC. It will also examine side effects, drug levels in blood over time, potential antibody development against the drugs, and impacts on quality of life.

What are the potential side effects?

Possible side effects from taking fianlimab and cemiplimab may include reactions related to the immune system affecting various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding tendencies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR) as assessed by blinded independent central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Secondary study objectives

Change from baseline in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC13)

Change from baseline in patient-reported cough per EORTC QLQ-LC13

Change from baseline in patient-reported dyspnea per EORTC QLQ-LC13

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