NCT05460481

Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors

Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors: A Multicenter, Single-arm, Explorative Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 # study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of advanced non-small-cell lung cancer (NSCLC) participants who have progressed following prior PD-1 or PD-L1 Inhibitors treatment, to further improve the patient's PFS or OS.

Detailed description

This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the efficacy and safety of anlotinib plus docetaxel in advanced NSCLC patients (pts) who have progressed following prior PD-1 or PD-L1 Inhibitors treatment.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-12
• Primary completion: 2023-06-01
• Completion: 2024-12-01
• First posted: 2022-07-15
• Last updated: 2022-07-20

Locations

1 site across 1 country: China