A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC.

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

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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria:

  1. 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
  2. Active tuberculosis infection, or a history of previous tuberculosis infection
  3. Uncontrolled, symptomatic brain metastases that are not effectively controlled or ahistory of psychiatric illness that cannot be easily controlled or severe intellectualor cognitive dysfunction
  4. 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
  5. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeateddrainage
  6. Subjects with the presence of any severe and/or uncontrolled disease
  7. Imaging showing tumour invasion of large vessels or poor demarcation from largevessels
  8. Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulationdisorders
  9. History of psychotropic substance abuse, alcoholism or drug addiction
  10. 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)
  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 tocooperate with follow-up visits
  13. 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

Study 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.