A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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EGFR-mutant Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: famitinib po
* Drug: HS-10296 po


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: famitinib, HS-10296<br> | Drug: famitinib po<br>* Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.<br>Drug: HS-10296 po<br>* Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 12-month-PFS | 12-month-progression free survival rate | From the start of treatment to 12 months | 
| Progression-Free-Survival (PFS) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 2 years | 
| 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) | 
| 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 |