Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable N… (NCT07560358) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer
China204 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
* Activ…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From enrollment to the end of monitoring at 1.5 years.
Trial details
NCT IDNCT07560358
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences