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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Hospital of China Medical University
RECRUITING
Shenyang
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Contact Information
Primary
Xiujuan Qu
cmu1h_zlnk_trial@163.com
13604031355
Time Frame
Start Date: 2024-08-09
Estimated Completion Date: 2026-08
Participants
Target number of participants: 38
Treatments
Experimental: Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib
Participants will receive adebrelimab plus carboplatin /cisplatin and etoposide during the induction phase (4-6 cycles of three weeks.). Thereafter, participants will receive maintenance (after induction phase) adebrelimab plus apatinib until persistent PD, intolerable toxicity or withdrawal of consent.
Sponsors
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Leads: Yunpeng Liu

This content was sourced from clinicaltrials.gov