Clinical trial NCT03904823: A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: EGFR-mutant Non-Small Cell Lung Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
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
measure: Duration of Response (DOR)
timeFrame: 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
measure: Disease Control Rate (DCR)
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
measure: Clinical Benefit Ratio (CBR)
timeFrame: From the start of treatment to 6 months
measure: 12-month-PFS
timeFrame: From the start of treatment to 12 months
measure: Progression-Free-Survival (PFS)
timeFrame: up to 2 years
measure: Number of Participants with Clinically significant toxicity
timeFrame: First cycle (21 days)
measure: Rate of Adverse Events and Serious Adverse Events
timeFrame: From the first drug administration to within 30 days after the last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Tongji University, Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References: