A Prospective, Single-center, Phase II Clinical Study of Adebrelimab Combined with Apatinib in the Treatment of Unresectable Stage III NSCLC Patients with Grade ≤2 Radiation Pneumonitis After Definitive Chemoradiotherapy

Wei Zhou1 site in 1 country32 target enrollmentAugust 13, 2024

ConditionsUnresectable Locally Advanced Non-small Cell Lung Cancer

InterventionsAdebrelimab + Apatinib

DrugsAdebrelimab + Apatinib

Overview

Phase: Phase 2
Intervention: Adebrelimab + Apatinib
Conditions: Unresectable Locally Advanced Non-small Cell Lung Cancer
Sponsor: Wei Zhou
Enrollment: 32
Locations: 1
Primary Endpoint: Progression free survival (PFS)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy

Detailed Description

Registry

clinicaltrials.gov

Start Date

August 13, 2024

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wei Zhou

Responsible Party

Sponsor Investigator

Principal Investigator

Wei Zhou

Director of Radiation Oncology Center

Chongqing University Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old, male or female;
•ECOG PS score 0-1;
•The expected survival time is not less than 12 weeks;
•Histologically or cytologically confirmed non-small cell lung cancer patients with unresectable locally advanced (stage III) (AJCC TNM staging, 8th edition);
•Patients who are not candidates for EGFR, ALK, or ROS1 targeted therapy, as confirmed by histologic or cytologic specimens (with documented evidence of no EGFR sensitizing mutation, ALK gene rearrangement, or ROS1 gene fusion);
•Patients with grade 2 or below radiation pneumonitis without disease progression after receiving platinum-based concurrent/sequential chemoradiotherapy;
•First dose was administered on days 1-42 (up to 42 days) after completion of concurrent/sequential platinum-based chemoradiotherapy for grade ≤1 RP; Patients with grade 2 RP who were downgraded to less than grade 1 RP within 56 days (including 56 days) after concurrent/sequential chemoradiotherapy received the first medication, and consolidation chemotherapy after radiotherapy was not allowed during the period.
•All toxic effects from previous antineoplastic therapy, except hearing loss, alopecia, and fatigue, had to have recovered to grade 1 or less (according to NCI CTCAE V5.0) or baseline levels to be eligible.
•Have not received any anti-CTLA-4, anti-PD-1, anti-PD-L1/2, anti-angiogenesis inhibitors, or anti-tumor vaccine therapy;
•Provide or collect biopsy tissue or blood samples during the treatment for biomarker analysis according to the subjects' wishes;

Exclusion Criteria

•Histological types of mixed small cell lung cancer and non-small cell lung cancer;
•Disease progression after chemoradiotherapy; Had undergone major surgery within 28 days before the first dose of a study drug or was planned to undergo major surgery during the study (at the investigator's discretion);
•Administration of live attenuated vaccine within 28 days prior to dose or planned for the duration of the study;
•Participated in another clinical study within 28 days before the first use of a trial drug, and used any trial drug;
•Grade ≥3 radiation pneumonitis caused by chemoradiotherapy;
•Imaging (CT/MRI) showed that the tumor invaded the large blood vessels or had unclear boundaries with blood vessels;
•Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
•Presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence;
•Congenital or acquired immune deficiency;
•Suffering from an infectious disease that is poorly controlled;

Arms & Interventions

Group A

Patients with grade 0-1 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 42 days after definitive chemoradiotherapy

Intervention: Adebrelimab + Apatinib

Group B

Patients with grade 2 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 56 days after definitive chemoradiotherapy

Intervention: Adebrelimab + Apatinib

Outcomes

Primary Outcomes

Progression free survival (PFS)

Time Frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months

Refers to the time from the start of nonrandomization until tumor progression or death from any cause, whichever occurs first

Secondary Outcomes

overall survival, OS(Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months)
Objective Response Rate, ORR(Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months)
Disease control rate, DCR(Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months)
Duration of response, DOR(Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months)