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

NCT ID: NCT06306560

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2027-04-15

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immuno-cherapy for extensive small cell lung cancer

Adebrelimab in combination with famitinib and chemotherapy

Group Type: EXPERIMENTAL

adebrelimab

Intervention Type: DRUG

adebrelimab IV

famitinib

Intervention Type: DRUG

famitinib PO

chemotherapy

Intervention Type: DRUG

chemotherapy IV

Interventions

adebrelimab

adebrelimab IV

Intervention Type: DRUG

famitinib

famitinib PO

Intervention Type: DRUG

chemotherapy

chemotherapy IV

Intervention Type: DRUG

Other Intervention Names

SHR-1316; SHR1020; cisplatin/carboplatin and etoposide

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yanbin Zhao

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanbin Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Harbin Medical University Cancer Hosptital

Central Contacts

Yanbin Zhao, MD

Role: CONTACT

zhaoyanbin1978@sina.com

13904811741

Other Identifiers

MA-SCLC-II-018

Identifier Type: -

Identifier Source: org_study_id