RecruitingPhase 1Phase 2NCT06217757

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

Sponsor

Sichuan University

Enrollment

45 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Extensive-stage Small-cell Lung Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of low-dose radiation therapy (LDRT) together with an immunotherapy drug (sugemalimab), chemotherapy, and a targeted drug (olaparib) in patients with advanced ovarian cancer. The goal is to see how safe and tolerable this combination is. **You may be eligible if...** - You have been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer - You are 18 or older and in adequate overall health - You have measurable disease and acceptable blood, liver, and kidney function - You are willing to use contraception during the study **You may NOT be eligible if...** - You have received prior treatment with certain immunotherapy or PARP inhibitor drugs - You have active autoimmune disease or are on immunosuppressive therapy - You have symptomatic brain metastases - You have active hepatitis B, C, or HIV - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONLow-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.

DRUGEtoposide

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).

DRUGCisplatin

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).

DRUGSugemalimab

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.

DRUGOlaparib

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.