An Exploratory Clinical Study of Adebrelimab in Combination With Famitinib and Chemotherapy for the Treatment of First-line Extensive Stage Small Cell Lung Cancer

Harbin Medical University0 sites40 target enrollmentMarch 15, 2024

ConditionsExtensive-stage Small-cell Lung Cancer

Interventionsadebrelimab famitinib chemotherapy

Overview

Phase: Phase 2
Intervention: adebrelimab
Conditions: Extensive-stage Small-cell Lung Cancer
Sponsor: Harbin Medical University
Enrollment: 40
Primary Endpoint: 6-month progression-free survival
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 15, 2024

End Date

April 15, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Harbin Medical University

Responsible Party

Principal Investigator

Yanbin Zhao

Harbin Medical University

Eligibility Criteria

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 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
•Patients voluntarily enrolled in this study by signing an informed consent form

Exclusion Criteria

•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
•Active tuberculosis infection, or a history of previous tuberculosis infection
•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
•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
•Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
•Subjects with the presence of any severe and/or uncontrolled disease
•Imaging showing tumour invasion of large vessels or poor demarcation from large vessels
•Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulation disorders
•History of psychotropic substance abuse, alcoholism or drug addiction
•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)