This is a randomized, controlled, multicenter clinical study that enrolled patients with unresectable bulky stage III NSCLC, with PFS as the primary endpoint. The study aims to investigate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the treatment of locally advanced/unresectable stage III non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Patients receive adebrelimab combined with chemotherapy for 2 cycles of induction therapy, followed by sequential/concurrent chemoradiotherapy (sCRT/cCRT), and then undergo adebrelimab monotherapy for consolidation treatment. adebrelimab: 1200 mg iv, q3w Radiation therapy: Total dose of 60 Gy ± 10% (range: 54 Gy - 66 Gy). Chemotherapy: Regimens will be administered in accordance with guideline recommendations. Subsequently, patients will receive adebrelimab monotherapy as consolidation treatment, with each treatment cycle lasting 3 weeks. Treatment will be continued until disease recurrence or metastasis, intolerable toxicity, subject's voluntary withdrawal, or investigator's decision to discontinue the subject from the study.
Receive cCRT/sCRT followed by maintenance immunotherapy. adebrelimab: 1200 mg iv, q3w Radiation therapy: Total dose of 60 Gy ± 10% (range: 54 Gy - 66 Gy). Chemotherapy: Regimens will be administered in accordance with guideline recommendations. Subsequently, patients will receive adebrelimab monotherapy as consolidation treatment, with each treatment cycle lasting 3 weeks. Treatment will be continued until disease recurrence or metastasis, intolerable toxicity, subject's voluntary withdrawal, or investigator's decision to discontinue the subject from the study.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documentation of disease progression according to RECIST v1.1 (as assessed by investigators) or death from any cause, whichever occurs first. Subjects who are alive without progression at the time of analysis will be censored at the date of the last tumor assessment.
Time frame: From enrollment to the end of monitoring at 1.5 years.
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last follow-up.
Time frame: From enrollment to the end of monitoring at 1.5 years.
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as per RECIST v1.1.
Time frame: From enrollment to the end of monitoring at 1.5 years.
Duration of Response (DoR)
DoR is defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death.
Time frame: From enrollment to the end of monitoring at 1.5 years.
The incidence of adverse events
Incidence, nature, and severity of adverse events (AEs), graded according to NCI-CTCAE v6.0, including immune-related AEs and serious AEs.
Time frame: From enrollment to the end of monitoring at 1.5 years
Time to Death or Distant Metastasis(TTDM)
From randomization/enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From enrollment to the end of monitoring at 1.5 years