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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from Day 1 in the first cycle.
100 mg or 200 mg q3w until disease progression or intolerable toxicity;
240 mg q3w until disease progression or intolerable toxicity;
Number of Participants with Dose-limiting Toxicitys (DLTs)
Time frame: up to 21 days after the first dose
Objective response rate (ORR)
Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) during treatment.
Time frame: up to 2 years
Disease control rate (DCR)
Defined as the proportion of subjects achieving complete response (CR) or partial response (PR) or stable disease (SD) during treatment.
Time frame: up to 2 years
Duration of response (DOR)
Defined as the time from the first documented response (CR or PR) to the first documented disease progression or death, whichever came first.
Time frame: up to 2 years
Progression-free survival (PFS)
Defined as the time from enrollment to the first documented disease progression or death from any cause, whichever came first.
Time frame: up to 2 years
Overall Survival (OS)
Defined as the time from enrollment to death due to any cause.
Time frame: up to 2 years
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75 mg/m2 q3w for 4-6 cycles;
AUC = 5, q3w for 4-6 cycles;
100 mg/m2, d1, d2, d3, q3w for 4-6 cycles;