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NCT Number: NCT06306560

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adebrelimab

Drug

adebrelimab IV

Other names: SHR-1316

Famitinib

Drug

famitinib PO

Other names: SHR1020

Chemotherapy

Drug

chemotherapy IV

Other names: cisplatin/carboplatin and etoposide

Primary outcomes

  1. 6-month progression-free survival

    Time frame: up to 6 months

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

Secondary outcomes

  1. 12-month progression-free survival

    Time frame: up to 12 months

    Proportion of disease progression or death from randomization to 12 months of treatment.

  2. Objective Response Rate

    Time frame: up to 24 months

    Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

  3. Disease control rate

    Time frame: up to 24 months

    Disease Control Rate, determined using RECIST v1.1 criteria.

  4. Overall Survival

    Time frame: up to 24 months

    Defined as the time from randomization to death from any cause.

  5. AEs

    Time frame: up to 24 months

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

  6. QoL

    Time frame: up to 24 months

    Defined as time from randomization to deterioration on each of the EORTC QLQ-C30 symptom subscales

  7. Progression-Free-Survival

    Time frame: up to 24 months

    Defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanbin Zhao, MD

CONTACT

[email protected]

13904811741

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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