NCT06217757

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study consists of dose escalation and dose expansion in China. Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with Sugemalimab, Etoposide/Cisplatin Chemotherapy and Olaparib for 4 cycles with LDRT in the first cycle. Sugemalimab in combination with olaparib will be administered for maintenance therapy after 4 cycles. Sugemalimab will be administered at a dose of 1200 mg every 3 weeks (Q3W) in the first day of every cycle. The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from day 1 in the first cycle. Dose of olaparib will identify by assessed recommended dose for expansion (RDE) in dose escalation stage.A dose expansion stage will be conducted after dose escalation. The primary endpoint is safety.

Conditions

• Lung Cancer
• 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 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.

Timeline

• Start date: 2024-04-18
• Primary completion: 2026-06-20
• Completion: 2027-03-20
• First posted: 2024-01-22
• Last updated: 2024-05-13

Locations

1 site across 1 country: China