Adebrelimab Plus Apatinib for Maintenance Treatment of Extensive Stage Small Cell Lung Cancer After First-line Induction with Adebrelimab Plus Chemotherapy (CLOG2402-ADAPT): a Multi-center, Single-arm, Phase 2 Clinical Trial
To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.
• Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;
• Age 18 years and above, male and female;
• Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed by histology or pathology (according to the American Veterans Lung Cancer Association, VALG stage);
• ECOG physical condition score is 0-2;
• Subjects have not received systematic treatment for ES-SCLC in the past (including chemotherapy, VEGFR inhibitors and immune checkpoint inhibitors, etc.)
• Patients with limited stage small cell lung cancer (LS-SCLC) who have received radiotherapy, chemotherapy or radiochemotherapy require a treatment-free period of more than 6 months. Patients with asymptomatic brain metastases are allowed to have cranial radiotherapy during induction chemotherapy;
• Life expectancy \>= 3 months;
• There must be a measurable target lesion that meets the RECIST 1.1 criteria (CT scan length of the tumour lesion \>10mm);
• The function of major organs is normal, that is, the following criteria are met.
‣ Blood routine (not transfused, not using haematopoietic factors and not corrected with drugs within 14 days): ANC ≥ 1.5 x 109/L; HB ≥ 90 g/L; PLT ≥ 100 × 109/L;
⁃ Biochemical tests:
• TBIL ≤ 1.5ULN; TBIL ≤ 1.5 ULN; ALT, AST ≤ 2.5 ULN;
• \- Renal function: Serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance ≥ 40 mL/min. (apply the standard Cockcroft-Gault formula):
• \- Coagulation function must meet: INR ≤ 1.5 and APTT ≤ 1.5 ULN;
⁃ Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential must agree to use a highly effective method of contraception and breastfeeding for the duration of the study up to 90 days after the last administration of study drug. The Investigator or his/her designee, in consultation with the subject, will be required to confirm that the subject has knowledge of how to properly and consistently use the contraceptive method;
⁃ For males, surgical sterilisation or agreement to use a highly effective method of contraception for the duration of the trial and for 90 days after the final administration of study drug;
⁃ For female participants, agreement to refrain from breastfeeding for the duration of the study or for 180 days after the last dose of study treatment is required.