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

Phase 2RecruitingNCT04951947

Hunan Province Tumor Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small-cell Lung Cancer

Interventions

JS201 combine with LenvatinibDRUG

JS201 300mg i.v Q2wLenvatinib 8mg po. Qd

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

ORR

Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

Time frame: 1 year

Secondary Outcomes

PFS

Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

Time frame: 1 year

Central Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436 zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613055193557 yangnong0217@163.com

Data from ClinicalTrials.gov

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