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NCT06306560Not yet recruitingPhase 2

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

An Exploratory Clinical Study of Adebrelimab in Combination With Famitinib and Chemotherapy for the Treatment of First-line Extensive Stage Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
29 Feb 2024
Start date
15 Mar 2024
Primary completion date
15 Mar 2027
Lead sponsor
Harbin Medical University
Diseases
Lung cancer
NCT number
NCT06306560

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 15 Mar 2024 to the primary completion date, 15 Mar 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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
  • Subjects with the presence of any severe and/or uncontrolled disease
  • 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

Other

  • Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
  • Imaging showing tumour invasion of large vessels or poor demarcation from large vessels
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.