OncRef

Clinical Trial: NCT05001971

Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Hunan Cancer Hospital
Information Provided By:Hunan Cancer Hospital
Last Update Posted:2026-01-15

Study Overview

Brief Summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase II ALTER1202 trial, patients who failed at least two kinds of systemic chemotherapy regimens (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 4.1 months and 7.3 months, the placebo group PFS and OS were 0.7 months and 4.9 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of sensitive relapsed small-cell lung cancer patients who were failure in the first-line treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.

Official Title

Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy: a Single-arm, Multicenter Pilot Study

Conditions

Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Anlotinib Plus Penpulimab

Other Study ID Numbers

  • ALTER-L041

Start Date (Actual)

2021-01-30

Primary Completion Date (Actual)

2025-01-21

Study Completion Date (Actual)

2025-04-15

Enrollment (Actual)

65

Study Type

Interventional

Phase

Phase 2