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

NCT ID: NCT04951947

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Small-cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Treatment arm

Group Type EXPERIMENTAL

JS201 combine with Lenvatinib

Intervention Type DRUG

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

Interventions

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JS201 combine with Lenvatinib

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunan Province Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongchang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Locations

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Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongchang Zhang, MD

Role: CONTACT

+8613873123436 ext. 7+861383123436

Nong Yang, MD

Role: CONTACT

+8613055193557 ext. +8613873123436

Facility Contacts

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Nong Yang, MD

Role: primary

+86 731 89762323

Yongchang Zhang, MD

Role: backup

+86 731 89762321

Other Identifiers

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JS-201

Identifier Type: -

Identifier Source: org_study_id

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