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

Small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04951947
• Other study ID #: JS-201
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Drug:
• JS201 combine with Lenvatinib
JS201 300mg i.v Q2wLenvatinib 8mg po. Qd

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	1 year
Secondary	PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	1 year