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NOT YET RECRUITING
NCT06732258
PHASE1

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

Sponsor: Sichuan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-01-10

Completion Date

2028-02-29

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

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;