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NCT Number: NCT04951947

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

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.

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Key information

Conditions

Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JS201 combine with Lenvatinib

Drug

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

Primary outcomes

  1. ORR

    Time frame: 1 year

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

Secondary outcomes

  1. PFS

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Yang, MD

CONTACT

[email protected]

+8613055193557 ext. +8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. 7+861383123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 7, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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