Spots Global Cancer Trial Database for Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer

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Trial Identification

Brief Title: Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer

Official Title: Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer: a Multicenter, Single-arm, Explorative Trial

Study ID: NCT05001971

Conditions

Small Cell Lung Cancer

Interventions

Anlotinib Plus Penpulimab

Study Description

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.

Detailed Description: This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the effectiveness and safety of Anlotinib Plus Penpulimab in patients of sensitive relapsed small-cell lung cancer. Eligible patients will receive 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.