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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• Subjects with known positive EGFR mutation or positive ALK fusion.

Egyéb

• 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.

• 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.