West Cancer Center

LUNG: NSCLC: METASTATIC: 1st LINE: R3767-ONC-2236

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

Title

Regeneron R3767-ONC-2236 LUNG FIANLIMAB PHASE III

Study Title

Site Link

NCT05800015

Malignancy

Lung Cancer, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Disease Setting

Metastatic/Unresectable

Line Of Therapy

1st Line

Investigational Agent

Fianlimab

Drug Class

Anti-LAG-3 antibody

Jason Porter, MD

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Metastatic or Stage IIIB or C unresectable non-small cell lung cancer
Availble PD-L1 results
Measurable disease
ECOG PS 0-1
No active CNS disease
Negative for EGFR mutations or ALK or ROS fusions
No history of insterstitial lung disease except resolved radiation pneumonitis
No autoimmune disease except hyopthyroidism
Cannot require corticosteroid treatment >10mg prednisone daily
May have received adjuvant or neoadjuvant therapy with platinum doublets, anti-PD1 with or without LAG-3, or CTLA-4, as long as greater than 6-12 months before enrollment (time off depends on the agent)

Objective

Primary
- ORR
- OS
Secondary
- Safety
- DCR
- TTR
- DOR
- PFS
- QOL
- PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Non-small cell lung cancer

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes