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

NCT07560358 | Not Yet Recruiting Phase 3

• 1 other identifier: NCC6182
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival (OS)

  From enrollment to the end of monitoring at 1.5 years.

• Objective Response Rate (ORR)

  From enrollment to the end of monitoring at 1.5 years.

• Duration of Response (DoR)

  From enrollment to the end of monitoring at 1.5 years.

• The incidence of adverse events

  From enrollment to the end of monitoring at 1.5 years

• Time to Death or Distant Metastasis（TTDM）

  From enrollment to the end of monitoring at 1.5 years

Other Outcomes (3)

• Incremental Cost-Utility Ratio (ICUR)

  From randomization/enrollment to the end of 1.5-year follow-up.

• Patient Quality of Life (QoL)

  From baseline to the end of 1.5-year follow-up.

• Exploratory biomarker analysis

  From enrollment to the end of 1.5-year follow-up.

Study Arms (2)

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.

Drug: After chemoimmunotherapy induction, followed by concurrent/sequential chemoradiotherapy and subsequent immune consolidation and maintenance therapy.

Receive cCRT/sCRT followed by maintenance immunotherapy.

ACTIVE COMPARATOR

Adebrelimab monotherapy consolidation is administered after sCRT/cCRT.

Drug: adebrelimab,Radiation Therapy,Radiotherapy

Interventions

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.

Receive cCRT/sCRT followed by maintenance immunotherapy.

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.

After chemoimmunotherapy induction followed by cCRT/sCRT, then maintenance immunotherapy.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Central Study Contacts

Zhijie Wang, MD

CONTACT

+86 13466323860; jie_969@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)