Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 4:48 PM
Study NCT ID:
NCT06773156
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-14
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Adebrelimab Plus Apatinib After Chemoradiation in Limited-Stage Small Cell Lung Cancer
Sponsor:
Second Affiliated Hospital of Nanchang University
Organization:
Study Overview
Official Title:
Sequential Adebrelimab Combined With Apatinib as Consolidation Therapy Following Concurrent Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer: A Prospective, Single-Arm, Multicenter Phase II Clinical Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 30±7 days until 90 days. The first (30±7 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 (60±7 days and 90±7 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.
\*\*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 30±7 days until 90 days. The first (30±7 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 (60±7 days and 90±7 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.
Detailed Description:
Dosing Regimen： Adebrelimab:Administered by intravenous infusion at a fixed dose of 1200 mg. The infusion should be completed within 30-60 minutes, with a maximum duration of 2 hours. The first dose is given on Day 1, with subsequent doses repeated every 3 weeks. Dose adjustments (either up or down) are not allowed during the study. A maximum delay of 9 weeks for treatment is allowed, or treatment may be terminated.
Apatinib: 250 mg, taken orally after meals, once daily, continuously. The investigator may temporarily pause the dose or adjust the administration schedule based on symptomatic treatment, such as changing to an every-other-day (qod) schedule or a 5-day-on, 2-day-off regimen. Once toxicity resolves, treatment may resume at the original dose.
The combined treatment of Adebrelimab + Apatinib for consolidation therapy should not exceed 24 months in total.
Primary Outcome Measure Progression-free survival (PFS) as assessed by the investigator (according to RECIST 1.1).
Secondary Outcome Measures
1. Efficacy:Overall survival (OS), 12-month/24-month/36-month OS rates, 12-month/18-month PFS rates (according to RECIST 1.1).
2. Safety: Including treatment-related adverse events (AEs), serious adverse events (SAEs), and the incidence of AEs and SAEs related to the study drugs (assessed based on the NCI CTCAE 5.0 criteria).
3. Quality of Life (QoL): Changes in symptoms, functions, and overall health status/QoL reported by the subjects.
Apatinib: 250 mg, taken orally after meals, once daily, continuously. The investigator may temporarily pause the dose or adjust the administration schedule based on symptomatic treatment, such as changing to an every-other-day (qod) schedule or a 5-day-on, 2-day-off regimen. Once toxicity resolves, treatment may resume at the original dose.
The combined treatment of Adebrelimab + Apatinib for consolidation therapy should not exceed 24 months in total.
Primary Outcome Measure Progression-free survival (PFS) as assessed by the investigator (according to RECIST 1.1).
Secondary Outcome Measures
1. Efficacy:Overall survival (OS), 12-month/24-month/36-month OS rates, 12-month/18-month PFS rates (according to RECIST 1.1).
2. Safety: Including treatment-related adverse events (AEs), serious adverse events (SAEs), and the incidence of AEs and SAEs related to the study drugs (assessed based on the NCI CTCAE 5.0 criteria).
3. Quality of Life (QoL): Changes in symptoms, functions, and overall health status/QoL reported by the subjects.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: