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Not yet recruitingNCT06306560Updated Mar 12, 2024

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

A Phase 2 interventional study of adebrelimab and famitinib in Extensive-stage Small-cell Lung Cancer, sponsored by Harbin Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Harbin Medical University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Extensive-stage Small-cell Lung Cancer

Keywords

  • Adebrelimab
  • Famitinib
  • Small-cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Immuno-cherapy for extensive small cell lung cancer

    Adebrelimab in combination with famitinib and chemotherapy

    Drug: adebrelimab · Drug: famitinib · Drug: chemotherapy

Interventions

  • Drugadebrelimab

    adebrelimab IV

    Also known as: SHR-1316

  • Drugfamitinib

    famitinib PO

    Also known as: SHR1020

  • Drugchemotherapy

    chemotherapy IV

    Also known as: cisplatin/carboplatin and etoposide

06

What researchers measure

Primary outcomes

  1. 6-month progression-free survival

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

    Time frame: up to 6 months

Secondary outcomes

  1. 12-month progression-free survival

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

    Time frame: up to 12 months

  2. Objective Response Rate

    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.

    Time frame: up to 24 months

  3. Disease control rate

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

    Time frame: up to 24 months

  4. Overall Survival

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

    Time frame: up to 24 months

  5. AEs

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

    Time frame: up to 24 months

  6. QoL

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

    Time frame: up to 24 months

  7. Progression-Free-Survival

    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.

    Time frame: up to 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06306560
Lead sponsor
Harbin Medical University
Responsible party
Yanbin Zhao (MD, Harbin Medical University) — Principal investigator
First posted
Mar 12, 2024
Start date
Mar 15, 2024 (estimated)
Primary completion
Mar 15, 2027 (estimated)
Completion
Apr 15, 2027 (estimated)
Last update
Mar 12, 2024

Study contacts

Yanbin Zhao, MD
Contact
zhaoyanbin1978@sina.com
13904811741
Yanbin Zhao, MD
principal investigator · Harbin Medical University Cancer Hosptital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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