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

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

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 Overview

• Status: Recruiting
• Conditions: Small-cell Lung Cancer
• Intervention / Treatment: Drug: JS201 combine with Lenvatinib

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nong Yang, MD; Phone Number: +8613873123436 +8613055193557; Email: yangnong0217@163.com
• Study Contact Backup: Name: Yongchang Zhang, MD; Phone Number: 7+861383123436 +8613873123436; Email: zhangyongchang@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Yongchang Zhang, MD; Phone Number: +86 731 89762321; Email: zhangyongchang@csu.edu.cn
      • Contact: Nong Yang, MD; Phone Number: +86 731 89762323; Email: yangnong0217@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Treatment arm	Drug: JS201 combine with Lenvatinib; JS201 300mg i.v Q2wLenvatinib 8mg po. Qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	1 year

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital
• Investigators: Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: JS-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No