Adjuvant Adebrelimab Plus Apatinib After Chemoradiation in Limited-Stage Small Cell Lung Cancer
Status:
ENROLLING_BY_INVITATION
Trial end date:
2030-08-01
Target enrollment:
Participant gender:
Summary
The study includes the screening period (from the time the subject signs the informed consent form to no more than 28 days before the first dose, imaging evaluations are allowed within 28 days before the first dose, and 5-14 days after the last radiotherapy/chemotherapy treatment, as close as possible to the treatment start date and the start of the study treatment), tumor tissue biopsy collection based on the subject's hospital, with preferred samples obtained within 3 months, but archived samples within 6 months before the first dose are also acceptable. The treatment period (until disease progression/worsening or confirmed radiological disease progression, or withdrawal for any reason) and the follow-up period (from the last dose to 36 months, including safety follow-up and survival follow-up).
\*\*Screening Period:\*\* Subjects who have received 2-4 cycles of platinum-based concurrent or induction chemotherapy (cCRT) and are evaluated as having non-progressive disease after cCRT, with the cCRT treatment ending within 1-42 days before the first dose, and the last radiotherapy session as the final end time. Consolidation chemotherapy after radiotherapy is not allowed.
Screening evaluation must be performed within 28 days before the first dose to determine eligibility. Tumor tissue samples should be collected based on the subject's hospital. The preferred samples are archived or freshly obtained tumor tissue wax blocks or pathological biopsy slides within 3 months, but archived samples within 6 months before the first dose are also acceptable.
\*\*Treatment Period:\*\* Each treatment cycle is 3 weeks. Atezolizumab 1200mg is administered via intravenous infusion, and Apatinib 250mg is taken orally after meals, once daily, for continuous use.
Subjects must undergo a comprehensive examination at the end of the study treatment or when withdrawing from the study, including vital signs, physical examination, laboratory tests, quality of life assessment, clinical tumor imaging evaluation (CT or MRI), and other necessary checks.
\*\*Follow-up Period:\*\* After the study treatment ends or the subject withdraws from the study, safety follow-up should be conducted. Subjects should be followed up every 307 days until 90 days. The first (307 days after withdrawal from the group) safety visit must be conducted at the research center, and vital signs, physical examination, laboratory tests, etc., should be assessed for AEs, concomitant medications, and supportive treatments. The other two visits (607 days and 907 days after withdrawal from the group) will be conducted by telephone, collecting survival information, AEs, concomitant medications, and supportive treatments.
After the safety follow-up is completed, subjects will be followed up every 3 months by phone to monitor survival status until death, loss to follow-up, withdrawal of informed consent, observation for 3 years, or termination of the study.