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

NCT03728374 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-11-02

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 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.

Conditions

  • Non-Small-Cell Lung Cancer

Interventions

DRUG

Anlotinib

Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle)

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Yuping Li, doctor · First Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-11-01
Completion
2020-11-01

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Drugs

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 NCT03728374 on ClinicalTrials.gov