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

NCT05001971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Anlotinib Plus Penpulimab

Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.

Sponsors & Collaborators

  • Fuzhou Pulmonary Hospital of Fujian

    collaborator OTHER
  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY
  • Hunan Cancer Hospital

    lead OTHER

Principal Investigators

  • Nong Yang, PhD · Hunan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-30
Primary Completion
2025-01-21
Completion
2025-04-15

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05001971 on ClinicalTrials.gov