CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 712 enrolled / 712 target
Drug / intervention
Pemetrexed +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03088540
NCT03088540Phase 3CompletedMonitor (6.5/mo)Completion was 14mo ago
CompareCT.gov

A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

Regeneron Pharmaceuticals·interventional·Posted Mar 23, 2017·Updated Jun 25, 2026

In Brief

A Phase 3 clinical trial evaluating Pemetrexed, Paclitaxel, and 4 other interventions for Carcinoma，Non-Small-Cell Lung and 3 related conditions. Completed, enrolled 712 participants across 192 sites in 24 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The primary objectives of the study are: * To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells * To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung Cancer
CountriesAustralia, Belarus, Brazil, Bulgaria, Chile, China, Colombia, Czechia, Georgia, Greece, Hungary, Jordan, Lebanon, Malaysia, Mexico, Philippines, Poland, Romania, Russia, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 23, 2017
Enrollment StartMay 29, 2017
Primary CompletionApr 18, 2025
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 9.3 years ago

Arms & Interventions

Standard-of-care chemotherapyactive_comparator

Standard-of-care chemotherapy will administered from these options: Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance

Drug: PemetrexedDrug: PaclitaxelDrug: GemcitabineDrug: CisplatinDrug: Carboplatin
cemiplimabexperimental

cemiplimab regimen as monotherapy as per study protocol

Drug: cemiplimab

Interventions

Pemetrexeddrug

Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin

Paclitaxeldrug

Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin

Gemcitabinedrug

Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin

Cisplatindrug

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

Carboplatindrug

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

cemiplimabdrug

Patients will be administered cemiplimab as per protocol.