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COMPLETED

NCT04702009

PHASE2/PHASE3

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

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy vs. Anti-PD-1/PD-L1 Monoclonal Antibody, Chemotherapy, in Combination With Bronchoscopy-assisted Interventional Therapy in the Treatment of Patients With Advanced Central Non-small Cell Lung Cancer, a Randomized Controlled, Prospective Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-01-20

Completion Date

2026-01-20

Last Updated

2026-07-21

Healthy Volunteers

Conditions

Advanced Lung Carcinoma Non-small Cell Lung Cancer

Interventions

DRUG

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

CIT (chemoimmunotherapy): anti-PD-1 sintilimab (Tyvyt) 200 mg IV on Day 1 q3w combined with platinum-based doublet chemotherapy at standard label doses selected by histology (squamous: gemcitabine + cisplatin/carboplatin or taxane + carboplatin; nonsquamous: pemetrexed + cisplatin/carboplatin). Treatment q3w for 4-6 cycles, then maintenance sintilimab ± pemetrexed until progression, unacceptable toxicity, consent withdrawal, or investigator decision. Dose modifications per labels/protocols; irAEs managed per guidelines (hold sintilimab, corticosteroids as indicated).

PROCEDURE

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

BIT: therapeutic flexible bronchoscopy with endobronchial tumor debulking performed exclusively with high-frequency electrocautery within 14 days after randomization (once before CIT or twice: before CIT and before Cycle 3). Performed under monitored anesthesia care (propofol-based deep sedation) or general anesthesia with airway control; topical lidocaine as needed. Electrocautery delivered via ES-300D electrosurgical generator (Beijing Taktvoll; monopolar cutting); energy individualized per lesion/manufacturer guidance. Goal: restore airway patency and relieve obstruction symptoms while minimizing bleeding/hypoxemia. Self-expanding tracheobronchial stent (Micro-Tech, Nanjing) placed when clinically indicated. No APC/cryotherapy/laser or other adjuncts. Continuous ECG, SpO2 and NIBP monitoring; complications recorded.

Inclusion Criteria: 1\) Patients volunteer to participate in clinical studies and sign an informed consent (ICF), and are willing to follow and able to complete all trial procedures. 2)18-75 years of age 3) All patients included are diagnosed with lung cancer detected by fibrous bronchoscope or percutaneous lung puncture biopsy, and are confirmed as NSCLC by Immunohistochemistry. 4\) Obstruction-type central lung cancer that cannot be surgically removed. 5) Patients without EGFR, ALK, and ROS mutation. 6) Patients have not previously received systemic treatment for phase IV NSCLC or patients receiving the adjuvant or neoadjuvant therapy for more than 6 months before the diagnosis of phase IV NSCLC. 7\) Within 4 weeks, at least one measurable lesions are required for researchers to evaluate in accordance with RECIST 1.1 requirements. 8\) Appropriate tumor tissues for PD-L1 expression level determination are required. 9\) Relevant laboratory tests indicate tolerance for chemotherapy, immunotherapy, and bronchoscopy. Exclusion Criteria: 1. Patients with uncertain diagnosis. 2. Non-central NSCLC patients. 3. Patients with contraindications to chemotherapy or immunotherapy. 4. Bronchoscopy is contraindicated in patients. 5. Patients have other active malignancies. Patients with cured limited tumors, such as skin substrate cell carcinoma, skin squamous cancer, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situ of cervix, and breast in-place cancer, can be included. 6. Patients with human immunodeficiency virus (HIV) infection. 7. Patients with infection of active tuberculosis. 8. Patients have received a live vaccines within 28 days of the first drug use. Patients receiving inactivated viral vaccines to treat seasonal influenza are allowed, but inactivated live influenza vaccines with intracn nasal drugs are not allowed. 9. Pregnant or lactating women. 10. Patients have a known history of psychosophedic substance abuse or drug abuse; 11. The researchers determined that there may be other factors that might have contributed to the early termination of the study.

Locations (1)

Shanghai pulmonary hospital, Tongji University

Shanghai, Shanghai Municipality, China