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RECRUITING
NCT06217757
PHASE1/PHASE2

Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC

Sponsor: Sichuan University

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.

Official title: Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-04-18

Completion Date

2027-03-20

Last Updated

2024-05-13

Healthy Volunteers

No

Interventions

RADIATION

Low-dose radiotherapy

The LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.

DRUG

Etoposide

Etoposide will be administered intravenously at a dose of 100 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

DRUG

Cisplatin

Cisplatin will be administered as intravenous infusion at a dose of 25 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

DRUG

Sugemalimab

Sugemalimab will be administered by intravenous infusion at a dose of 1200mg on Day 1 of each 21-day cycle for a maximum of 2 years or progressive disease or intolerable toxicity.

DRUG

Olaparib

Olaparib will be administered orally at a dose of 150mg qod Day 1,3,5,7 or 150 mg qd/150 mg bid/300mg in the morning and 150mg in the evening/300 mg bid on Day 1-7 of each 21-day cycle for a maximum of 2 years or progressive disease or intolerable toxicity.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China