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Recruiting NCT04951947

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

Phase II Interventional Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JS201 combine with Lenvatinib.
Who it may be relevant to
Registry conditions: Small-cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Interventions

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

Primary outcome measures

  • ORR [Time frame: 1 year]
Secondary outcome measures (1)
  • PFS [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Hunan Cancer Hospital — Changsha

Identifiers

NCT: NCT04951947 · JS-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗