Phase II Clinical Study of Adebrelimab Combined with Apatinib in the Treatment of Locally Advanced Non-small Cell Lung Cancer Patients with Radiation Pneumonitis

1. Age ≥18 years old, male or female;

2. ECOG PS score 0-1;

3. The expected survival time is not less than 12 weeks;

4. Histologically or cytologically confirmed non-small cell lung cancer patients with unresectable locally advanced (stage III) (AJCC TNM staging, 8th edition);

5. Patients who are not candidates for EGFR, ALK, or ROS1 targeted therapy, as confirmed by histologic or cytologic specimens (with documented evidence of no EGFR sensitizing mutation, ALK gene rearrangement, or ROS1 gene fusion);

6. Patients with grade 2 or below radiation pneumonitis without disease progression after receiving platinum-based concurrent/sequential chemoradiotherapy;

7. First dose was administered on days 1-42 (up to 42 days) after completion of concurrent/sequential platinum-based chemoradiotherapy for grade ≤1 RP; Patients with grade 2 RP who were downgraded to less than grade 1 RP within 56 days (including 56 days) after concurrent/sequential chemoradiotherapy received the first medication, and consolidation chemotherapy after radiotherapy was not allowed during the period.

All toxic effects from previous antineoplastic therapy, except hearing loss, alopecia, and fatigue, had to have recovered to grade 1 or less (according to NCI CTCAE V5.0) or baseline levels to be eligible.

9\. Have not received any anti-CTLA-4, anti-PD-1, anti-PD-L1/2, anti-angiogenesis inhibitors, or anti-tumor vaccine therapy; 10. Provide or collect biopsy tissue or blood samples during the treatment for biomarker analysis according to the subjects' wishes; 11. Normal function of major organs and bone marrow; 12. Female subjects of childbearing potential had to have a negative serum or urine pregnancy test 72 hours before starting the trial and be willing to use a highly effective, medically approved contraceptive method for the duration of the study and for 90 days after the last dose of the trial drug; Male participants whose partner was a woman of childbearing potential agreed to use an effective method of contraception or to be surgically sterilized for the duration of the study and for 90 days after the last dose of the trial drug.

13\. The subjects voluntarily participated in this study, and signed the informed consent form. The compliance was good, and the efficacy and adverse reactions were followed up according to the protocol.

What this study is about