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

NCT06306560 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-SCLC-II-018
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Keywords

Adebrelimab; Famitinib; Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival

  Proportion of disease progression or death from randomization to 6 months of treatment.

  up to 6 months

Secondary Outcomes (7)

• 12-month progression-free survival

  up to 12 months

• Objective Response Rate

  up to 24 months

• Disease control rate

  up to 24 months

• Overall Survival

  up to 24 months

• AEs

  up to 24 months

Study Arms (1)

Immuno-cherapy for extensive small cell lung cancer

EXPERIMENTAL

Adebrelimab in combination with famitinib and chemotherapy

Drug: adebrelimab; Drug: famitinib; Drug: chemotherapy

Interventions

adebrelimab DRUG

adebrelimab IV

Also known as: SHR-1316

Immuno-cherapy for extensive small cell lung cancer

famitinib DRUG

famitinib PO

Also known as: SHR1020

Immuno-cherapy for extensive small cell lung cancer

chemotherapy DRUG

chemotherapy IV

Also known as: cisplatin/carboplatin and etoposide

Immuno-cherapy for extensive small cell lung cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive
• Patients who are unable to comply with the trial protocol or who are unable to cooperate with follow-up visits
• Patients who, in the opinion of the investigator, should not be enrolled in the trial

Sponsors & Collaborators

• Harbin Medical University: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

famitinib; Drug Therapy; Cisplatin; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Yanbin Zhao, MD

  Harbin Medical University Cancer Hosptital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanbin Zhao, MD

CONTACT

13904811741; zhaoyanbin1978@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share