Clinical trial NCT06306560: A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC.
Official title: An Exploratory Clinical Study of Adebrelimab in Combination With Famitinib and Chemotherapy for the Treatment of First-line Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Extensive-stage Small-cell Lung Cancer
Keywords: Adebrelimab
Famitinib
Small-cell Lung Cancer
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.

Detailed description: This study plans to recruit 40 patients with extensive-stage small cell lung disease who have not received treatment, observe and evaluate the effectiveness and safety of adebrelimab combined with famitinib and chemotherapy.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-80 years old, male or female
2. Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging)
3. Never received prior systemic therapy for extensive stage small cell lung cancer
4. Have a measurable tumour target lesion (meeting RECIST 1.1 criteria)
5. Expected survival \> 3 months
6. ECOG PS: 0-1 points
7. Normal function of major organs
8. Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose
9. Patients voluntarily enrolled in this study by signing an informed consent form

Exclusion Criteria:

1. Previous or concurrent other malignant tumours within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer
2. Active tuberculosis infection, or a history of previous tuberculosis infection
3. Uncontrolled, symptomatic brain metastases that are not effectively controlled or a history of psychiatric illness that cannot be easily controlled or severe intellectual or cognitive dysfunction
4. Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment
5. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
6. Subjects with the presence of any severe and/or uncontrolled disease
7. Imaging showing tumour invasion of large vessels or poor demarcation from large vessels
8. Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulation disorders
9. History of psychotropic substance abuse, alcoholism or drug addiction
10. Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA test value exceeding the upper limit of normal value Hepatitis C reference HCV antibody positive with HCV viral titre test value exceeding the upper limit of normal value)
11. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive
12. Patients who are unable to comply with the trial protocol or who are unable to cooperate with follow-up visits
13. Patients who, in the opinion of the investigator, should not be enrolled in the trial

Primary outcomes:
measure: 6-month progression-free survival
timeFrame: up to 6 months
Secondary outcomes:
measure: 12-month progression-free survival
timeFrame: up to 12 months
measure: Objective Response Rate
timeFrame: up to 24 months
measure: Disease control rate
timeFrame: up to 24 months
measure: Overall Survival
timeFrame: up to 24 months
measure: AEs
timeFrame: up to 24 months
measure: QoL
timeFrame: up to 24 months
measure: Progression-Free-Survival
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Harbin Medical University Cancer Hosptital
name: Yanbin Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: