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