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
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.
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.
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 →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.
Exclusion Criteria:
Adebrelimab in combination with famitinib and chemotherapy
Drug: adebrelimab · Drug: famitinib · Drug: chemotherapy
adebrelimab IV
Also known as: SHR-1316
famitinib PO
Also known as: SHR1020
chemotherapy IV
Also known as: cisplatin/carboplatin and etoposide
6-month progression-free survival
Proportion of disease progression or death from randomization to 6 months of treatment.
Time frame: up to 6 months
12-month progression-free survival
Proportion of disease progression or death from randomization to 12 months of treatment.
Time frame: up to 12 months
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
Disease control rate
Disease Control Rate, determined using RECIST v1.1 criteria.
Time frame: up to 24 months
Overall Survival
Defined as the time from randomization to death from any cause.
Time frame: up to 24 months
AEs
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: up to 24 months
QoL
Defined as time from randomization to deterioration on each of the EORTC QLQ-C30 symptom subscales
Time frame: up to 24 months
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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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Harbin Medical University