Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Conditions:
Advanced Lung Carcinoma
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 cance...
Detailed Description
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 lu...
Eligibility Criteria
Inclusion
- 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
- Patients with uncertain diagnosis.
- Non-central NSCLC patients.
- Patients with contraindications to chemotherapy or immunotherapy.
- Bronchoscopy is contraindicated in patients.
- 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.
- Patients with human immunodeficiency virus (HIV) infection.
- Patients with infection of active tuberculosis.
- 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.
- Pregnant or lactating women.
- Patients have a known history of psychosophedic substance abuse or drug abuse;
- The researchers determined that there may be other factors that might have contributed to the early termination of the study.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04702009
Start Date
January 20 2021
End Date
January 20 2026
Last Update
January 8 2021
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