Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer

A Randomized Controlled Clinical Study of Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer

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 Overview

• Status: Not yet recruiting
• Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
• Intervention / Treatment: Drug: After chemoimmunotherapy induction, followed by concurrent/sequential chemoradiotherapy and subsequent immune consolidation and maintenance therapy.; Drug: adebrelimab,Radiation Therapy,Radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhijie Wang, MD; Phone Number: +86 13466323860; Email: jie_969@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;
• Expected survival time of at least 3 months;
• No prior anti-tumor treatment before enrollment, including radiotherapy, chemotherapy, surgery and targeted therapy;
• Adequate function of major organs;
• Female subjects must have a negative pregnancy test result and be willing to use effective contraception;
• Subjects voluntarily participate in the study, sign the informed consent form, with good compliance and willingness to complete follow-up.

Exclusion Criteria:

• 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.
• Subjects with congenital or acquired immunodeficiency, such as HIV infection; or with a history of autoimmune diseases.
• Active hepatitis B, hepatitis C, or co-infection with both hepatitis B and hepatitis C.
• Uncontrolled third-space effusions, such as massive pleural effusion, ascites or pericardial effusion.
• History of other malignant tumors (other than NSCLC) within 5 years prior to screening.
• Subjects with prior interstitial lung disease requiring hormone therapy.
• Subjects with severe cardiovascular and cerebrovascular diseases.
• History of severe bleeding events or arterial/venous thromboembolic events.
• Severe infection within 4 weeks before the first dose; evidence of active tuberculosis infection within 1 year prior to the first dose; active fungal, bacterial and/or viral infections requiring systemic treatment.
• Subjects with prior or planned allogeneic bone marrow transplantation or solid organ transplantation.
• History of live attenuated vaccination within 28 days before the first dose, or planned live attenuated vaccination during the study period; pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptive measures.
• Known hypersensitivity, anaphylactic reaction or intolerance to adebrelimab, chemotherapy agents, or their excipients.
• Subjects with a known history of psychoactive substance abuse, alcoholism or drug addiction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: After chemoimmunotherapy induction followed by cCRT/sCRT, then maintenance immunotherapy.; 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.	Drug: After chemoimmunotherapy induction, followed by concurrent/sequential chemoradiotherapy and subsequent immune consolidation and maintenance therapy.; 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.
Active Comparator: Receive cCRT/sCRT followed by maintenance immunotherapy.; Adebrelimab monotherapy consolidation is administered after sCRT/cCRT.	Drug: adebrelimab,Radiation Therapy,Radiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Health Care Facilities Workforce and Services; Maintenance
• Other Study ID Numbers: NCC6182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No