Clinical Research Directory
Browse clinical research sites, groups, and studies.
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
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.
Official title: Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-03-14
Completion Date
2027-04-01
Last Updated
2024-09-19
Healthy Volunteers
No
Interventions
Serplulimab
Specified dose on specified days
Carboplatin
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Nab-paclitaxel
Specified dose on specified days
Liposomal paclitaxel
Specified dose on specified days
Surgery
Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.
Radiotherapy
Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.
Locations (1)
Shanghai Pulmonary Hospital
Shanghai, China