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Brief Title: Toripalimab in Combination With Platinum-based Chemotherapy for Mutation-negative Stage IV Oligometastatic NSCLC
Official Title: Toripalimab in Combination With Platinum-based Chemotherapy in Patients With Mutation-negative Stage IV Oligometastatic NSCLC: A Phase II Study.
Study ID: NCT05055583
Brief Summary: In recent years, immune checkpoint inhibitors targeting cytotoxic T-lymphocyte antigen-4, programmed death-1, and programmed death-ligand 1 have achieved milestones in the treatment of NSCLC, from back-line to first-line, and beyond. Is changing the standard of care for NSCLC. Currently, several phases Ⅲ clinical studies of neoadjuvant immunity combined with standard chemotherapy are underway, suggested that neoadjuvant ICI therapy is a promising way for locally advanced lung cancer. As an intermediate state in the process of tumor metastasis, Oligometastatic NSCLC patients have a better prognosis and more likely to benefit from local treatment than patients with extensive distant metastasis. However, there have been few reports of salvage surgery after ICI treatment in Oligometastatic NSCLC, and only one case has been reported to date. There is therefore a need to further gather evidence on salvage surgery after ICI.
Detailed Description: This is a single-center, single-arm, prospective phase II study to evaluate the efficacy and safety of toripalimab in combination with platinum-based and surgery in patients with mutation-negative stage IV Oligometastatic NSCLC.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Fourth Military Medical University Tangdu Hospital, Xi'an, Shaanxi, China
Name: Tao Jiang, PH.D
Affiliation: The Fourth Military Medical University Tangdu Hospital
Role: PRINCIPAL_INVESTIGATOR