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.
Lung cancer is one of the malignant tumors with high morbidity and mortality. Most patients with lung cancers are already in advanced stages when diagnosed, and the 5-year survival rate of advanced lung cancer is less than 5%. Therefore, exploring effective treatments is of great significance for improving the survival and quality of life of patients with lung cancer. Immunotherapy represented by immune checkpoint inhibitors has received widespread attention in the field of lung cancer, and 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%, 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 interventional 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 and chemotherapy in combination with bronchoscopy-assisted interventional therapy versus anti-PD-1/PD-L1 monoclonal antibody in combination with chemotherapy as the first-line treatment of patients with advanced central NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
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).
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.
Shanghai pulmonary hospital, Tongji University
Shanghai, Shanghai Municipality, China
progression free survival (PFS)
To evaluate the progression free survival (PFS) in the first-line treatment of patients with advanced central NSCLC
Time frame: 1 year
objective response rate (ORR)
To evaluate the objective response rate (ORR) in the first-line treatment of patients with advanced central NSCLC
Time frame: 6 weeks
disease control rate (DCR)
To evaluate the disease control rate (DCR) in the first-line treatment of patients with advanced central NSCLC
Time frame: 6 weeks
overall survival (OS)
To evaluate the overall survival (OS) in the first-line treatment of patients with advanced central NSCLC
Time frame: 2 years
Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v5.0
To evaluate the side effects in the first-line treatment of patients with advanced central NSCLC
Time frame: 2 years
quality of life (QoL)
To evaluate the quality of life (QoL) in the first-line treatment of patients with advanced central NSCLC
Time frame: 2 years
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