Efficacy of IBI-322 with Lenvatinib for Extensive Stage Small Cell Lung Cancer
Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer and Assessment of Biomarkers
This study is trying to see how well the combination of IBI-322 and Lenvatinib works for people with extensive-stage small cell lung cancer who haven't had success with their first treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05991180 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect real-world data on the effectiveness of IBI-322 in combination with Lenvatinib for patients with extensive-stage small cell lung cancer (SCLC). It focuses on patients who have not responded to first-line treatment with PD-(L)1 inhibitors or have progressed after initial responses. The study will gather epidemiological data without intervening in the current medical practices of the participants. By analyzing this data, the study seeks to provide insights into treatment outcomes in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with extensive-stage SCLC who have not responded to or have progressed after first-line PD-(L)1 inhibitor therapy.
Not a fit: Patients who have not been treated with PD-(L)1 inhibitors or those with early-stage SCLC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the effectiveness of a new treatment combination for patients with extensive-stage SCLC.
How similar studies have performed: While this approach is observational and builds on existing treatment paradigms, similar studies have shown promise in understanding treatment efficacy in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Changsha, Hunan
- Hunan Cancer hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Yongchang Zhang, MD
- Email: zhangyongchang@csu.edu.cn
- Phone: +8613873123436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.