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

Hunan Province Tumor Hospital

Status and phase: Enrolling; Phase 2

Conditions: Small-cell Lung Cancer

Treatments: Drug: JS201 combine with Lenvatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04951947

JS-201

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Arm A

Experimental group

Description:

Treatment arm

Treatment:

Drug: JS201 combine with Lenvatinib