NCT04951947

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

June 30, 2021

Last Update Submit

September 17, 2024

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • ORR

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

    1 year

Secondary Outcomes (1)

  • PFS

    1 year

Study Arms (1)

Arm A

EXPERIMENTAL

Treatment arm

Drug: JS201 combine with Lenvatinib

Interventions

JS201 combine with LenvatinibDRUG

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

Arm A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. The imaging diagnosis is the extensive stage of SCLC
  • \. The patient failed first-line EC+PD-L1 treatment
  • PS 0-1

You may not qualify if:

  • \. Diagnosed as non-small cell lung cancer
  • \. Women during pregnancy
  • \. Patients with symptomatic brain metastases
  • \. PS≥2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yongchang Zhang, MD

    Hunan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613055193557yangnong0217@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

June 30, 2021

First Posted

July 7, 2021

Study Start

June 1, 2023

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CN(1)