Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| After chemoimmunotherapy induction followed by cCRT/sCRT, then maintenance immunotherapy. | Experimental | Patients receive adebrelimab(1200 mg iv, q3w) combined with chemotherapy for 2 cycles of induction therapy, followed by sequential/concurrent chemoradiotherapy (sCRT/cCRT), and then undergo adebrelimab monotherapy for consolidation treatment. |
|
| Receive cCRT/sCRT followed by maintenance immunotherapy. | Active Comparator | Adebrelimab monotherapy consolidation is administered after sCRT/cCRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| After chemoimmunotherapy induction, followed by concurrent/sequential chemoradiotherapy and subsequent immune consolidation and maintenance therapy. | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of monitoring at 1.5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of monitoring at 1.5 years. |
| Objective Response Rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From randomization/enrollment to the end of 1.5-year follow-up. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhijie Wang, MD | Contact | +86 13466323860 | jie_969@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| adebrelimab,Radiation Therapy,Radiotherapy | Drug | 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. |
|
ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as per RECIST v1.1. |
| 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. | 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. | 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. | From enrollment to the end of monitoring at 1.5 years |
| 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. | From baseline to the end of 1.5-year follow-up. |
| Exploratory biomarker analysis | Exploratory analysis of relevant biomarker characteristics and their correlation with clinical efficacy outcomes. | From enrollment to the end of 1.5-year follow-up. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided