Adebrelimab with chemotherapy and radiation for large, inoperable lung cancer

Who can take part

• 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

Who cannot take part

• 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 prior interstitial lung disease requiring hormone therapy
• 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
• 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
• History of other malignant tumors (other than NSCLC) within 5 years prior to screening
• Subjects with severe cardiovascular and cerebrovascular diseases
• History of severe bleeding events or arterial/venous thromboembolic events
• 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
• 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
• Uncontrolled third-space effusions, such as massive pleural effusion, ascites or pericardial effusion