Last updated: March 5, 2024
Sponsor: Harbin Medical University
Overall Status: Active - Not Recruiting
Phase
2
Condition
Small Cell Lung Cancer
Treatment
adebrelimab
famitinib
chemotherapy
Clinical Study ID
NCT06306560
MA-SCLC-II-018
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age: 18-80 years old, male or female
- Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging)
- Never received prior systemic therapy for extensive stage small cell lung cancer
- Have a measurable tumour target lesion (meeting RECIST 1.1 criteria)
- Expected survival > 3 months
- ECOG PS: 0-1 points
- Normal function of major organs
- Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior toinitiation of treatment, and women of childbearing potential and men (who are sexuallyactive with women of childbearing potential) must agree to use effective contraceptionuninterruptedly for the duration of the treatment period and for 6 months after theadministration of the last therapeutic dose
- Patients voluntarily enrolled in this study by signing an informed consent form
Exclusion
Exclusion Criteria:
- Previous or concurrent other malignant tumours within 5 years, except cured basal cellcarcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasivebladder cancer
- Active tuberculosis infection, or a history of previous tuberculosis infection
- Uncontrolled, symptomatic brain metastases that are not effectively controlled or ahistory of psychiatric illness that cannot be easily controlled or severe intellectualor cognitive dysfunction
- Subjects with active, known or suspected autoimmune disease, hypothyroidism requiringonly hormone replacement therapy, skin disorders not requiring systemic therapy (e.g.,vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeateddrainage
- Subjects with the presence of any severe and/or uncontrolled disease
- Imaging showing tumour invasion of large vessels or poor demarcation from largevessels
- Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulationdisorders
- History of psychotropic substance abuse, alcoholism or drug addiction
- Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA test valueexceeding the upper limit of normal value Hepatitis C reference HCV antibody positivewith HCV viral titre test value exceeding the upper limit of normal value)
- Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive
- Patients who are unable to comply with the trial protocol or who are unable tocooperate with follow-up visits
- Patients who, in the opinion of the investigator, should not be enrolled in the trial
Study Design
Total Participants: 40
Treatment Group(s): 3
Primary Treatment: adebrelimab
Phase: 2
Study Start date:
March 15, 2024
Estimated Completion Date:
April 15, 2027