Overview

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

Status:
Completed
Trial end date:
2019-06-28
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hutchison Medipharma Limited
Treatments:
Gefitinib
Criteria
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