NCT04670107

The Combination of Anlotinib and Immune Checkpoint Inhibitors for Advanced NSCLC Patients With Muti-line Therapy

The Combination of Anlotinib and Immune Checkpoint Inhibitors for Progressed NSCLC Patients With Muti-line Therapy : a PhaseⅠB Clinical Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immunotherapy has made a major progress in Lung cancer.However, challenges such as primary and acquired resistance, small fraction of benefit population and lack of predictive and prognostic biomarkers even exist. The overall objective response rate is lower than 20% in second line-treatment and the progression-free survival (PFS) is also similar to or poorer than that of conventional second-line chemotherapy. Anlotinib is a novel, orally administered, multitarget receptor tyrosine kinase inhibitor that inhibits VEGFR, PDGFR, FGFR, c-Kit, and other kinases. It functions by inhibiting tumor angiogenesis and proliferative signaling pathways. We would observe and analyze the effectiveness and safety of anlotinib combined with Immune checkpoint inhibitors for advanced NSCLC after muti-line therapy to explore the synergistic effect of anti-angiogenic agents and immunotherapy.

Conditions

• NSCLC
• Angiogenesis
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Anlotinib in combination with Immune checkpoint inhibitors	Enrolled patients received anlotinib plus Pembrolizumab treatment (anlotinib, 8-12mg, qd, 2 weeks in a row and 1 week off; anti-PD1 injection or anti-PDL1 injection, Following instructions, iv.)

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-10-01
• Completion: 2020-11-01
• First posted: 2020-12-17
• Last updated: 2020-12-17

Locations

1 site across 1 country: China