Clinical trial · Interventional
A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer
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
NCT02976116CI-TRIAL-00041664completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fruquintinib | Drug | Fruquintinib | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fruquintinib & Gefitinib
- description
- Drug: Fruquintinib and Gefitinib
- interventionNames
- Drug: Fruquintinib
- Drug: Gefitinib
Primary outcomes (2)
- measure
- tumor objective response rate
- timeFrame
- Patients will be followed until study completion, an average of 1 year
- description
- Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1
- measure
- Safety and tolerability
- timeFrame
- Each patient will be followed for 30 days after the last dose
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.