A Phase 2/3 interventional study of Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy and Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy in Advanced Lung Carcinoma and Non-small Cell Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 2/3, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 33 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.
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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:
Participants randomized to CIT alone received standard first-line chemoimmunotherapy (CIT) per protocol (see Intervention description).
Drug: Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy
Participants randomized to BIT+CIT underwent bronchoscopic intervention therapy (BIT) within 14 days after randomization (either 1 session before CIT initiation or 2 sessions: before CIT and before Cycle 3), followed by first-line CIT. BIT consisted of therapeutic flexible bronchoscopy with endobronchial tumor debulking using high-frequency electrocautery; airway stent could be placed if clinically indicated. CIT was administered per protocol (see Intervention description).
Drug: Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy · Procedure: 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).
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.
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
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication, limited to the variables necessary to reproduce the reported analyses, will be made available to qualified researchers upon reasonable request. A data dictionary, study protocol, and statistical analysis plan will also be available. No direct participant identifiers will be shared.
Supporting information: Study protocol, Sap
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Shanghai Pulmonary Hospital, Shanghai, China