NCT03432598

Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

Completed Phase 2 Last updated 23 October 2024

What this trial tests

Phase 2 trial testing Tislelizumab in Locally Advanced Lung Cancer; Metastatic Lung Cancer in 54 participants. Completed in 21 December 2020.

Timeline

24 August 2017

Primary endpoint
25 February 2019

21 December 2020

Quick facts

Lead sponsor	BeiGene
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	24 August 2017
Primary completion	25 February 2019
Estimated completion	21 December 2020
Sites	7 locations across China

Drugs / interventions tested

• Tislelizumab (TISLELIZUMAB) — full drug profile →
• Paclitaxel — full drug profile →
• Gemcitabine
• Etoposide
• Pemetrexed — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Carboplatin

Conditions studied

• Locally Advanced Lung Cancer; Metastatic Lung Cancer — all drugs for Locally Advanced Lung Cancer; Metastatic Lung Cancer →

Sponsor

BeiGene — full company profile →

Who can join

Adults 18 to 75, any sex, with Locally Advanced Lung Cancer; Metastatic Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB-A317 in combination with standard platinum-based chemotherapy in participants with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Participants with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., participants with adenocarcinoma component accounting for \> 50% will be allocated to non-squamous NSCLC cohort.). Participants with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.

Publications & conference data

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

1. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.
   Wang J, Lu S, Yu X, Hu Y, et al · · 2021 · cited 312× · PMID 33792623 · DOI 10.1001/jamaoncol.2021.0366
2. Emerging therapeutic agents for advanced non-small cell lung cancer.
   Chen R, Manochakian R, James L, Azzouqa AG, et al · · 2020 · cited 244× · PMID 32448366 · DOI 10.1186/s13045-020-00881-7
3. Signal pathways and precision therapy of small-cell lung cancer.
   Yuan M, Zhao Y, Arkenau HT, Lao T, et al · · 2022 · cited 72× · PMID 35705538 · DOI 10.1038/s41392-022-01013-y
4. Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody.
   Zhang L, Geng Z, Hao B, Geng Q. · · 2022 · cited 66× · PMID 35926155 · DOI 10.1177/10732748221111296
5. Clinical application of immunogenic cell death inducers in cancer immunotherapy: turning cold tumors hot.
   Han Y, Tian X, Zhai J, Zhang Z. · · 2024 · cited 20× · PMID 38774648 · DOI 10.3389/fcell.2024.1363121
6. Emerging therapeutic frontiers in cancer: insights into posttranslational modifications of PD-1/PD-L1 and regulatory pathways.
   Wang R, He S, Long J, Wang Y, et al · · 2024 · cited 18× · PMID 38654302 · DOI 10.1186/s40164-024-00515-5
7. Current and future therapies for small cell lung carcinoma.
   Zhai X, Zhang Z, Chen Y, Wu Y, et al · · 2025 · cited 15× · PMID 40170056 · DOI 10.1186/s13045-025-01690-6
8. Immune Check Point Inhibitors and Immune-Related Adverse Events in Small Cell Lung Cancer.
   Hou W, Zhou X, Yi C, Zhu H. · · 2021 · cited 14× · PMID 33816235 · DOI 10.3389/fonc.2021.604227