unresectable NSCLC
Conditions
Interventions
treatment group:Adebrelimab+chemotherapy
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 to 70 years old, both males and females; (2) ECOG performance status: 0-1; (3) Histopathologically or cytologically confirmed non-small cell lung cancer (NSCLC), with patients deemed to have unresectable NSCLC by a multidisciplinary team (MDT). (4) Subjects must be able to provide fresh or archival tumor tissue. (5) Measurable lesions must be present. (6) Pulmonary function tests should be conducted within one month prior to the first study treatment. If clinically indicated, the tests should be repeated during the screening period. (7) Major organ functions should be essentially normal. (8) Female subjects of childbearing potential must have a negative blood pregnancy test within one week prior to the first administration of the drug. (9) Voluntarily participate in this clinical trial and sign the "informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with EGFR mutations or ALK rearrangements; (2) Histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcomatoid carcinoma; (3) Presence of malignant pleural effusion. If the subject has accessible pleural effusion during the screening period, at least one thoracentesis is required to confirm the presence of malignant tumor cells; (4) Have previously received any anti-neoplastic treatment, including radiotherapy, chemotherapy, or immunotherapy; (5) Participation in another clinical study within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first administration of the study medication; (6) Received systemic immunosuppressive therapy within 2 weeks before the first administration, or expected to require systemic immunosuppressive drug therapy during the study treatment period; (7) Suffer from congenital or acquired immune function deficiency; (8) Presence of uncontrollable third space effusion; (9) History of autoimmune disease; (10) History of other malignancies within the past 5 years, except for non-small cell lung cancer; (11) Subjects with a history of interstitial pneumonia requiring steroid therapy; (12) Subjects with severe cardiovascular or cerebrovascular diseases; (13) Complicated by severe infection within 4 weeks before the first administration; evidence of active tuberculosis infection within the past year before the first administration; (14) Subjects who have previously undergone or are expected to undergo allogeneic bone marrow transplantation or solid organ transplantation; (15) History of live attenuated vaccine administration within 28 days before the first administration, or expected to receive live attenuated vaccine during the study period; (16) Arterial/venous thrombotic events occurred within the past 3 months; presence of thrombophilia requiring routine anticoagulation therapy with warfarin or heparin, or long-term antiplatelet therapy; (17) Clinically significant bleeding symptoms occurred within 1 month before the first administration, or a tendency towards bleeding; (18) Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to use effective contraception; (19) Known hypersensitivity, allergic reactions, or intolerance to adebrelimab, chemotherapy, or its excipients; (20) Subjects with a history of substance abuse, alcoholism, or drug addiction; (21) Any condition deemed by the investigator that could jeopardize the subject or prevent the subject from meeting or fulfilling the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Major pathologic response rate;Pathological complete response rate;Event free survival;Overall survival;Disease-free survival;Adverse event; | — |
Countries
China
Contacts
Public ContactHan Yang
Sun Yat-Sen University Cancer Center
Outcome results
None listed