NCT05800015

A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer

Active, enrolled Phase 2, PHASE3 Last updated 22 January 2026

What this trial tests

Phase 2, PHASE3 trial testing fianlimab in Non-small Cell Lung Cancer in 950 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 August 2023

Primary endpoint
16 January 2030

23 December 2031

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 2, PHASE3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	950
Start date	8 August 2023
Primary completion	16 January 2030
Estimated completion	23 December 2031
Sites	76 locations across Georgia, Malaysia, Taiwan, Israel, South Korea, Canada, Thailand, Australia

Drugs / interventions tested

• fianlimab
• cemiplimab (CEMIPLIMAB) — full drug profile →
• Pemetrexed — full drug profile →
• Paclitaxel — full drug profile →
• Carboplatin
• Cisplatin (cisplatin) — full drug profile →
• Placebo

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC).

The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How much of each study drug is in your blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
* How administering the study drugs might improve your quality of life

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting T cell exhaustion: emerging strategies in non-small cell lung cancer.
   Liu X, Xi X, Xu S, Chu H, et al · · 2024 · cited 40× · PMID 39726592 · DOI 10.3389/fimmu.2024.1507501
2. LAG-3 : recent developments in combinational therapies in cancer.
   Chavanton A, Mialhe F, Abrey J, Baeza Garcia A, et al · · 2024 · cited 25× · PMID 38702996 · DOI 10.1111/cas.16205
3. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
4. Therapeutic potential of targeting LAG-3 in cancer.
   Davar D, Anderson AC, Diaz-Padilla I. · · 2025 · cited 8× · PMID 40633935 · DOI 10.1136/jitc-2025-011652
5. Targeting Immune Checkpoint Inhibitors for Non-Small-Cell Lung Cancer: Beyond PD-1/PD-L1 Monoclonal Antibodies.
   Roussot N, Kaderbhai C, Ghiringhelli F. · · 2025 · cited 8× · PMID 40075753 · DOI 10.3390/cancers17050906
6. The tumor immune microenvironment: implications for cancer immunotherapy, treatment strategies, and monitoring approaches.
   Racacho KJ, Shiau YP, Villa R, Mahri S, et al · · 2025 · cited 6× · PMID 41058701 · DOI 10.3389/fimmu.2025.1621812
7. Lung cancer organoid-based drug evaluation models and new drug development application trends.
   Lee E, Lee SY, Seong YJ, Ku B, et al · · 2024 · cited 4× · PMID 39830742 · DOI 10.21037/tlcr-24-603
8. Next-generation immunotherapy: igniting new hope for lung cancer.
   Li MSC, Chan ALS, Mok KKS, Chan LL, et al · · 2024 · cited 3× · PMID 39649017 · DOI 10.1177/17588359241302021