NCT06732258

Low-dose Radiotherapy Combined with Concurrent Chemotherapy, Toripalimab and Tifcemalimab in the Treatment of ES-SCLC

Exploratory Clinical Study of Low-dose Radiotherapy Combined with Concurrent Chemotherapy, Toripalimab and Tifcemalimab in First-line Treatment of Extensive-Stage Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the tolerability and safety of Low-dose radiotherapy combined with concurrent Chemotherapy, Toripalimab and Tifcemalimab in first-line treatment of Extensive-Stage Small Cell Lung Cancer, and to determine the RP2D.

Detailed description

This is a single-center, single-arm, exploratory clinical study to evaluate the safety and tolerability of low-dose radiotherapy (LDRT) concurrent chemotherapy combined with toripalimab and Tifcemalimab (JS004) in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Approximately 6-12 subjects were planned to be enrolled in this clinical study. The study will adopt a "3 + 3" dose escalation design, and the observation period for dose-limiting toxicities (DLTs) is 21 days after the first dose administration. Patients who meet the inclusion criteria will receive toripalimab 240 mg q3w, tifcemalimab 100 mg or 200 mg q3w until disease progression or intolerable toxicity; cisplatin for injection 75 mg/m2 or carboplatin AUC = 5, q3w, etoposide 100 mg/m2, d1, d2, d3, q3w for 4-6 cycles; low-dose radiotherapy with a total dose of 15 Gy, radiotherapy will be started on Cycle 1 Day 1 in 5 divided doses (15 Gy/5F).

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Low-dose radiotherapy	The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from Day 1 in the first cycle.
DRUG	Tifcemalimab injection	100 mg or 200 mg q3w until disease progression or intolerable toxicity;
DRUG	Toripalimab	240 mg q3w until disease progression or intolerable toxicity;
DRUG	Cisplatin	75 mg/m2 q3w for 4-6 cycles;
DRUG	Carboplatin	AUC = 5, q3w for 4-6 cycles;
DRUG	Etoposide	100 mg/m2, d1, d2, d3, q3w for 4-6 cycles;

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-02-28
• Completion: 2028-02-29
• First posted: 2024-12-13
• Last updated: 2024-12-27