NCT04702009

Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy and Bronchoscopy-assisted Interventional Therapy in Patients With Advanced Central Non-small Cell Lung Cancer

Completed Phase 2, PHASE3 Last updated 8 January 2021

What this trial tests

Phase 2, PHASE3 trial testing Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy in Advanced Lung Carcinoma in 33 participants. Completed in 20 January 2026.

Timeline

20 January 2021

Primary endpoint
31 March 2022

20 January 2026

Quick facts

Lead sponsor	Shanghai Pulmonary Hospital, Shanghai, China
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	33
Start date	20 January 2021
Primary completion	31 March 2022
Estimated completion	20 January 2026

Drugs / interventions tested

• Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy
• Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy

Conditions studied

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

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Who can join

Adults 18 to 75, any sex, with Advanced Lung Carcinoma or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lung cancer is one of the malignant tumors with high morbidity and mortality. Several PD-1/PD-L1 immune checkpoint inhibitors have been approved for the treatment of advanced non-small cell lung cancer (NSCLC). However, its overall effective population is only 20%, and even in studies of enriched populations (such as PD-L1 ≥ 50%), its single-drug effective rate is only about 40%. Therefore, this study aims to explore the efficacy and safety of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted lnterventional therapy in the first-line treatment of advanced central non-small cell lung cancer. We conducted a randomized controlled, prospective clinical trial to examine the efficacy, safety, and mechanism of anti-PD-1/PD-L1 monoclonal antibodies, chemotherapy, in combination with bronchoscopy-assisted interventional therapy vs anti-PD-1/PD-L1 monoclonal antibody in combination with chemotherapy as the first-line treatment of patients with advanced central NSCLC.

Publications & conference data

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

1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
2. Reshaping the systemic tumor immune environment (STIE) and tumor immune microenvironment (TIME) to enhance immunotherapy efficacy in solid tumors.
   Xu L, Zou C, Zhang S, Chu TSM, et al · · 2022 · cited 131× · PMID 35799264 · DOI 10.1186/s13045-022-01307-2