JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer

Phase 2

Recruiting

• Conditions: Small-cell Lung Cancer
• Interventions: Drug: JS201 combine with Lenvatinib

• Registration Number: NCT04951947
• Lead Sponsor: Hunan Province Tumor Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-07
• Study Start: 2023-06-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	JS201 combine with Lenvatinib	Treatment arm

Primary Outcome Measures

Name	Time	Method
ORR	1 year	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	1 year	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China