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.
Aged between 18 and 75 years;
ECOG performance status score of 0 or 1;
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
Unresectable stage III NSCLC (per AJCC 9th edition staging), with primary tumor diameter T ≥ 5 cm or regional metastatic lymph node short-axis diameter N ≥ 2 cm;
Subjects with known positive EGFR mutation or positive ALK fusion.
Histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcomatoid carcinoma.
Participation in another clinical trial within 4 weeks prior to the first study dose or within 5 half-lives of the study drug, whichever is shorter.
Subjects who have received systemic immunosuppressive therapy within 2 weeks before the first dose, or those who are expected to require systemic immunosuppressive drugs during the study treatment period.
Parallel
After chemoimmunotherapy induction, followed by concurrent/sequential chemoradiotherapy and subsequent immune consolidation and maintenance therapy.
DrugPatients 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.
adebrelimab,Radiation Therapy,Radiotherapy
DrugReceive 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.
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.
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.
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.
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.
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.
Incremental Cost-Utility Ratio (ICUR)
The Incremental Cost-Utility Ratio (ICUR) is defined as the incremental total cost divided by the incremental quality-adjusted life years (QALYs) between the experimental treatment group and the control group. It reflects the additional cost required to gain one additional unit of health utility outcome (per QALY).
Patient Quality of Life (QoL)
Patient Quality of Life (QoL) was assessed using validated patient-reported outcome questionnaires. Changes in health-related quality of life from baseline to scheduled follow-up time points were analyzed, including physical function, emotional function, social function and disease-related symptom domains.
Exploratory biomarker analysis
Exploratory analysis of relevant biomarker characteristics and their correlation with clinical efficacy outcomes.
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