Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer
Recruiting
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Registration Number
- NCT05991180
- Lead Sponsor
- Hunan Province Tumor Hospital
- Brief Summary
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- Patients must be ≥18 years.
- Provision of fully informed consent prior to any study specific procedures.
- Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).
- According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.
Exclusion Criteria
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ORR 2 years Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
- Secondary Outcome Measures
Name Time Method PFS 2 years Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
OS 2 years Defined as the time from the start of treatment to the death of the subject due to any cause.
Trial Locations
- Locations (1)
Hunan Cancer hospital
🇨🇳Changsha, Hunan, China