NCT03728374

Anlotinib Hydrochloride as Second-line Therapy in Elderly Patients With EGFR Wild-type Lung Adenocarcinoma

Anlotinib Hydrochloride as Second-line Therapy in Elderly Patients With EGFR Wild-type Lung Adenocarcinoma Who Refused Chemotherapy: an Open, Single-arm, Single-center Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 65 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 Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib（12mg，po. qd. on day 1to14 of a 21-day cycle） 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. Subgroup analysis results suggest that elderly patients may get longer mPFS and mOS. Therefore, the investigators envisage an open, single-arm, single-center clinical trial using anlotinib in elderly patients with EGFR wild-type lung adenocarcinoma who refused chemotherapy, to find if anlotinib is a better option in NSCLC second-line therapy.

Detailed description

It is an open, single-arm, single-center clinical trial conducted in China, and plan to Recruiting 38 patients (≥65 years old, ECOG PS 0-2) who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle)

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-11-01
• Completion: 2020-11-01
• First posted: 2018-11-02
• Last updated: 2018-11-02