Combining JS-201 and Lenvatinib for Small-cell Lung Cancer Treatment
A Prospective, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer With Previous Chemotherapy Combined With PD-L1 Failure
This study is testing if combining the drugs JS-201 and lenvatinib can help people with small-cell lung cancer who haven't responded to earlier treatments feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | lenvatinib, chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT04951947 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of JS-201 in combination with lenvatinib for patients with small-cell lung cancer who have not responded to previous chemotherapy and PD-L1 treatment. It is a single-arm phase II study that focuses on measuring the overall response rate (ORR) as the primary endpoint, while progression-free survival (PFS) and overall survival (OS) are secondary endpoints. Patients will receive JS-201 intravenously every two weeks and lenvatinib orally daily.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with extensive-stage small-cell lung cancer who have failed first-line chemotherapy and PD-L1 treatment.
Not a fit: Patients with non-small cell lung cancer or those with symptomatic brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with small-cell lung cancer who have limited treatment alternatives.
How similar studies have performed: While this approach is novel in combining JS-201 with lenvatinib, similar studies have shown promise in treating small-cell lung cancer with other combinations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. The imaging diagnosis is the extensive stage of SCLC * 2\. The patient failed first-line EC+PD-L1 treatment * 3 PS 0-1 Exclusion Criteria: * 1\. Diagnosed as non-small cell lung cancer * 2\. Women during pregnancy * 3\. Patients with symptomatic brain metastases * 4\. PS≥2
Where this trial is running
Changsha, Hunan
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
- 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.