EGFR-mutant Non-Small Cell Lung Cancer Clinical Trial
Official title:
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)
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.
| Status | Recruiting |
| Enrollment | 58 |
| Est. completion date | December 2022 |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Tongji University, Shanghai Pulmonary Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | 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 | |
| Secondary | Depth of Response (DepOR) | Percentage of total target lesion diameter reduced from baseline when at best overall response | 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 | |
| Secondary | Duration of Response (DOR) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | From the first partial response or complete response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | |
| Secondary | Disease Control Rate (DCR) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | 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 | |
| Secondary | Clinical Benefit Ratio (CBR) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | From the start of treatment to 6 months | |
| Secondary | 12-month-PFS | 12-month-progression free survival rate | From the start of treatment to 12 months | |
| Secondary | Progression-Free-Survival (PFS) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 2 years | |
| Secondary | Number of Participants with Clinically significant toxicity | Number of Participants with Clinically significant toxicity per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | First cycle (21 days) | |
| Secondary | Rate of Adverse Events and Serious Adverse Events | Rate of Adverse Events and Serious Adverse Events per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | From the first drug administration to within 30 days after the last dose |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03333343 -
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
|
Phase 1 |