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Not yet recruiting NCT06306560

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

Phase II Interventional Extensive-stage Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: adebrelimab, famitinib, chemotherapy.
Who it may be relevant to
Registry conditions: Extensive-stage Small-cell Lung Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug adebrelimab
    adebrelimab IV
  • Drug famitinib
    famitinib PO
  • Drug chemotherapy
    chemotherapy IV

Primary outcome measures

  • 6-month progression-free survival [Time frame: up to 6 months]
Secondary outcome measures (7)
  • 12-month progression-free survival [Time frame: up to 12 months]
  • Objective Response Rate [Time frame: up to 24 months]
  • Disease control rate [Time frame: up to 24 months]
  • Overall Survival [Time frame: up to 24 months]
  • AEs [Time frame: up to 24 months]
  • QoL [Time frame: up to 24 months]
  • Progression-Free-Survival [Time frame: up to 24 months]

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)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06306560 · MA-SCLC-II-018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗