NCT04951947 JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer
| NCT ID | NCT04951947 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hunan Province Tumor Hospital |
| Condition | Small-cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-06-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is 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 that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.
Eligibility 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
Contact & Investigator
Yongchang Zhang, MD
PRINCIPAL INVESTIGATOR
Hunan Cancer Hospital
Frequently Asked Questions
Who can join the NCT04951947 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Small-cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04951947 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04951947 currently recruiting?
Yes, NCT04951947 is actively recruiting participants. Contact the research team at zhangyongchang@csu.edu.cn for enrollment information.
Where is the NCT04951947 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT04951947 clinical trial?
NCT04951947 is sponsored by Hunan Province Tumor Hospital. The principal investigator is Yongchang Zhang, MD at Hunan Cancer Hospital. The trial plans to enroll 30 participants.
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