NCT05055583

Toripalimab in Combination With Platinum-based Chemotherapy for Mutation-negative Stage IV Oligometastatic NSCLC

Toripalimab in Combination With Platinum-based Chemotherapy in Patients With Mutation-negative Stage IV Oligometastatic NSCLC: A Phase II Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC Stage IV
• Oligometastasis

Interventions

Type	Name	Description
DRUG	Toripalimab in Combination With Platinum-based Chemotherapy	Toripalimab will be administered at a fixed dose of 80 mg (2ml)/vial, IV, D1, with a full dose of 240 mg at one time, every 3 weeks for 3-4 cycles. Squamous cell carcinoma will be combined with cisplatin/carboplatin and Nab-paclitaxel: carboplatin, AUC=5, D1, IV, q3w, or cisplatin, 75 mg/m2, IV, q3w, and Nab-paclitaxel, 130 mg/m2, D1, IV, q3w, for 3-4 cycles. Non-squamous cell carcinoma will be combined with cisplatin/carboplatin and Pemetrexed, cisplatin/carboplatin is the same as above, Pemetrexed will be given at 500 mg/m2, D1, IV, q3w, for 3-4 cycles.
PROCEDURE	Surgical treatment stage	After the last treatment (Day 21 of Cycle 4), surgery was performed within 4-6 weeks.
DRUG	Adjuvant treatment stage	Postoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention will receive maintenance therapy within 6-12 weeks of the MDT assessment. Toripalimab: a fixed dose of 80 mg (2ml)/vial, IV, D1, a full dose of 240 mg at one time, every 3 weeks administered until PD or intolerable toxicity, for a maximum duration of 1 year.

Timeline

• Start date: 2021-08-31
• Primary completion: 2023-08-31
• Completion: 2023-12-31
• First posted: 2021-09-24
• Last updated: 2021-09-24

Locations

1 site across 1 country: China