A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer

HUTCHMED

Status and phase

Completed

Phase 2

Conditions

NSCLC

Treatments

Drug: Gefitinib

Drug: Fruquintinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02976116

2016-013-00CH1

Details and patient eligibility

About

Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study

Full description

This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed Informed Consent Form.
Age between 18 to 75 years old.
Histologically or cytological documented stage IIIB/IV non-squamous non-small cell lung cancer patients who have never received systematic treatment for the late-stage disease.
ECOG 0-1
Patients must have measurable lesions

Exclusion criteria

Prior systematic treatment for the advanced NSCLC
Absolute neutrophil count (ANC) < 1.5×10^9 /L, or platelet count < 100 ×10^9/L, or hemoglobin < 9 g/dL
Total bilirubin > 1 ULN; SGOT (AST), SGPT (ALT), > 1.5 ULN; for patient with liver metastasis，AST or ALT > 3 ULN
Known HIV positive
Hypersensitivity to either of the investigation drugs