Phase 3 N=789 Randomized Quadruple-blind Treatment

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

Non-small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03409614 ↗

Enrolled (actual)

789

Serious AEs

29.4%

Results posted

Apr 2026

Primary outcome: Primary: Part 1: Overall Survival (OS) — 15.9; 20.1; 13.9 months — p=0.1782

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: REGN2810 (Drug); REGN2810/chemo/ipi (Drug); Chemotherapy (Other); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Regeneron Pharmaceuticals
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1: Overall Survival (OS)	15.9; 20.1; 13.9	0.1782
PRIMARY Part 2: OS	21.1; 12.9	0.0002 sig
SECONDARY Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)	6.5; 6.4; 6.4	—
SECONDARY Part 2: PFS Per IRC	8.2; 5.5	<0.0001 sig
SECONDARY Part 1: Objective Response Rate (ORR) Per IRC	40.7; 36.7; 28.3	—
SECONDARY Part 2: ORR Per IRC	43.6; 22.1	<0.0001 sig
SECONDARY Part 1: Duration of Response (DoR)	7.8; 15.9; 6.2	—
SECONDARY Part 2: DoR	16.4; 7.3	—
SECONDARY Part 1: Best Overall Response (BOR) Per IRC	3; 5; 2; 41; 35; 28	—
SECONDARY Part 2: BOR Per IRC	20; 0; 116; 34; 121; 75	—
SECONDARY Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	105; 104; 99	—
SECONDARY Part 2: Number of Participants With TEAEs	301; 145	—
SECONDARY Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)	—	—
SECONDARY Part 1: Number of Participants With Serious TEAEs	37; 37; 22	—
SECONDARY Part 2: Number of Participants With Serious TEAEs	95; 37	—
SECONDARY Part 1: Number of Deaths During the On-Treatment Period	36; 24; 18	—
SECONDARY Part 2: Number of Deaths During the On-Treatment Period	85; 39	—
SECONDARY Part 1: Estimated Survival Probability	59.4; 68.5; 54.0; 47.5; 51.9; 39.7	—
SECONDARY Part 2: Estimated Survival Probability	66.4; 53.9; 53.7; 35.8; 43.9; 27.7	—
SECONDARY Part 1: Change From Baseline in Global Health Status Score as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	2.13; 1.58; 0.92; 4.65; 2.75; 2.16	—
SECONDARY Part 2: Change From Baseline in Global Health Status Score as Measured by the EORTC QLQ-C30	0.31; 1.50; 0.96; 2.80; 1.92; 4.09	—

Summary

The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in <50% of tumor cells. Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. The key secondary objectives are: Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of tumor cells. Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

Eligibility Criteria

Key Inclusion Criteria

Men and women ≥20 years of age for Japanese patients
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
Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has not previously been irradiated
Part 1 only: Expression of PD-L1 in 10 mg prednisone/day or equivalent) within 14 days of randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03409614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.