Clinical trial · Interventional
A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC
An Open, Single-arm, Multi-center, Phase 2 Clinical Trial of Famitinib Combined With Epidermal Growth Factor Receptor (EGFR) Inhibitor HS-10296 in Patients With Advanced EGFR-mutant Non-Small Cell Lung Cancer (NSCLC)
NCT03904823CI-TRIAL-00059527unknownPhase 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)
The study is being conducted to evaluate the efficacy, safety and tolerability of famitinib combined with HS-10296 in subjects with advanced EGFR-mutant NSCLC.
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 |
|---|---|---|---|
| EGFR-mutant Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| famitinib po | Drug | — | UNRESOLVED |
| HS-10296 po | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- famitinib, HS-10296
- interventionNames
- Drug: famitinib po
- Drug: HS-10296 po
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
- description
- Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Secondary outcomes (8)
- measure
- Depth of Response (DepOR)
- timeFrame
- From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject's written informed consent obtained prior to any process, sampling, or analysis related to the study. * Male or female, no less than 18 years old. * Confirmed as NSCLC by histology or cytology. * Locally advanced or metastatic NSCLC and not suitable for radical surgery or radiotherapy. * Have not received EGFR Tyrosine Kinase Inhibitor (TKI) therapy. * At least one baseline tumor lesion. * Can swallow pills normally. * Eastern Cooperative Oncology Group (ECOG) performance status 0\~1 points, expected survival≥12 weeks. * Adequate organ function. Exclusion Criteria: * Clinically symptomatic central nervous system metastases. * Ascites, pleural effusion or pericardial effusion with clinical symptoms. * Other malignant tumors in the past 5 years or at the same time. * High blood pressure which are not well controlled. * Heart disease that are not well controlled. * Coagulation dysfunction, bleeding tendency or receiving thrombolysis or anticoagulant therapy. * History of bleeding. * Known hereditary or acquired bleeding and thrombophilia. * Any serious or uncontrolled ocular lesion. * Interstitial lung disease or non-infectious pneumonia treated with corticosteroids. * Congenital or acquired immunodeficiency. * Other factors that may affect the results of the study or cause the study to be terminated midway.
References
Publications (0)
Data not yet available
No reference posted for this study.