EGFR-mutant Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGfamitinib po
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
DRUGHS-10296 po
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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 | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | 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 | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Disease Control Rate (DCR) | 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 | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Clinical Benefit Ratio (CBR) | From the start of treatment to 6 months | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Depth of Response (DepOR) | 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 | Percentage of total target lesion diameter reduced from baseline when at best overall response |
| Progression-Free-Survival (PFS) | up to 2 years | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Number of Participants with Clinically significant toxicity | First cycle (21 days) | Number of Participants with Clinically significant toxicity per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 |
| Rate of Adverse Events and Serious Adverse Events | From the first drug administration to within 30 days after the last dose | Rate of Adverse Events and Serious Adverse Events per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 |
| 12-month-PFS | From the start of treatment to 12 months | 12-month-progression free survival rate |
Countries
China
Contacts
Primary ContactQuanren Wang, PhD
Backup ContactWeixia Li, Master
Outcome results
None listed