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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.
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).
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).
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGRDE
To determine the RDE of olaparib in subjects with Extensive Stage-SCLC when combined with low-Dose Radiotherapy, chemotherapy and sugemalimab.
Time frame: 3 weeks after initiation of treatment.
Progression-free survival (PFS)
The time from the date of first dosing of sugemalimab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).
Time frame: Baseline up to approximately 24 months
PFS Rate at 6 Months and 1 Year
PFS rate at 6 months and 1 year, defined as the proportion of patients who have not experienced disease progression or death from any cause at 6 months and 1 year separately, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST1.1).
Time frame: Baseline up to 1 year
Overall Survival (OS)
OS, defined as the time from initiation of study treatment to death from any cause.
Time frame: Baseline up to approximately 24 months
OS Rate at 1 Year, 1.5 Years and 2 Years
OS rate at 1 year, 1.5 years and 2 years, defined as the proportion of patients who have not experienced death from any cause at 1 year ,1.5 years and 2 years.
Time frame: Baseline to 2 years or death, whichever occurs first.
Objective response rate (ORR)
According to the evaluation criteria of RECIST1.1
Time frame: Baseline to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.