Phase 3
Completed N=789
Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
Source: ClinicalTrials.gov NCT03409614 ↗Enrolled (actual)
789
Serious AEs
29.4%
Results posted
Apr 2026
Primary outcomePrimary: Part 1: Overall Survival (OS) — 15.9; 20.1; 13.9 months — p=0.1782
◆ Published Evidence
Highly cited
302citations · ~76 / year
Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.
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.
Linked Publications (4)
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Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.
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Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial.
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Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 ≥ 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial.
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Cemiplimab Plus Chemotherapy Could Be a First-Line Option for Advanced and Metastatic NSCLC: Results From the Phase 3 EMPOWER-Lung 3 Part 2 Trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03409614) and the linked publication. 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. Informational only — not medical advice.