NCT05766800 Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
| NCT ID | NCT05766800 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Condition | Locally Advanced |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-14 |
| Primary Completion | 2025-04-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.
Eligibility Criteria
Inclusion Criteria: 1. The patient shall sign the Informed Consent Form. 2. Aged 18 ≥ years. 3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS). 4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. 5. Life expectancy is at least 12 weeks. 6. At least 1 measurable lesion according to RECIST 1.1. 7. Patients with good function of other main organs (liver, kidney, blood system, etc.) 8. Patients with normal lung function can tolerate surgery; 9. Without systematic metastasis (including M1a, M1b and M1c); 10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative. 11. Unsterilized male patients must voluntarily use effective contraception during