Status:
COMPLETED
Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients
Lead Sponsor:
CStone Pharmaceuticals
Conditions:
Relapsed Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients
Detailed Description
This is a dose-escalation study of Low-dose Radiation in combination with CS1001 in relapsed SCLC patients. Patients are assigned to 3 treatment groups received from 3 Gy to 15Gy, to determine the saf...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed LS-SCLC or ES-SCLC and experienced progression since first-line standard platinum containing dual-drug chemotherapy.
- Patients whose initial diagnosis was limited must undergo radical chest radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or cannot receive radical chest radiotherapy due to specific reasons
- At least one extracranial measurable lesion (RECIST v1.1), and for a lesion that has received radiotherapy, progression of the lesion after radiotherapy must be confirmed.
- Patients with brain metastases are allowed to receive previous radiotherapy and their condition is stable, but the time to the end of radiotherapy must not be less than 3 months.
- No radiotherapy contraindications were judged by the radiologist
- ECOG performance status of 0 or 1.
- Patients with life expectancy ≥ 3 months.
- Patients must have adequate organ function.
- Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 6 months after last study drug administration.
Exclusion
- Subjects known to have primary CNS tumors or meningeal metastases or unstable CNS metastases.
- Patients with active autoimmune diseases or history of autoimmune diseases should be excluded.
- Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- Known history of HIV infection.
- Subjects with active chronic hepatitis B or active hepatitis C .
- Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
- Known history of alcoholism or drugs abuse.
- Subjects with history of radiation pneumonitis of grade 3 or above, regardless of recovered or not.
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04421352
Start Date
January 12 2021
End Date
December 22 2023
Last Update
March 7 2024
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041