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

Official title

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

Overview

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.

Interventions

• 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 treatme
• 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

Primary outcome measures

• Progression-Free Survival (PFS) [Time frame: From enrollment to the end of monitoring at 1.5 years.]

Secondary outcome measures (5)

• Overall Survival (OS) [Time frame: From enrollment to the end of monitoring at 1.5 years.]
• Objective Response Rate (ORR) [Time frame: From enrollment to the end of monitoring at 1.5 years.]
• Duration of Response (DoR) [Time frame: From enrollment to the end of monitoring at 1.5 years.]
• The incidence of adverse events [Time frame: From enrollment to the end of monitoring at 1.5 years]
• Time to Death or Distant Metastasis（TTDM） [Time frame: From enrollment to the end of monitoring at 1.5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chine — Beijing

Identifiers

NCT: NCT07560358 · NCC6182

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗