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

NCT03904823 | Unknown Phase 2

• 1 other identifier: FMTN-II-203-NSCLC
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

EGFR-mutant Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• 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

• Clinical Benefit Ratio (CBR)

  From the start of treatment to 6 months

• 12-month-PFS

  From the start of treatment to 12 months

Study Arms (1)

famitinib, HS-10296

EXPERIMENTAL

Drug: famitinib po; Drug: HS-10296 po

Interventions

famitinib po DRUG

Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.

famitinib, HS-10296

HS-10296 po DRUG

Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.

famitinib, HS-10296

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Tongji University, Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Study Officials

• Caicun Zhou, PhD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanren Wang, PhD

CONTACT

+86 18036618570; wangquanren@hrglobe.cn

Weixia Li, Master

CONTACT

+86 15005136260; liweixia@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 5, 2019
• Study Start: April 25, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-06

Locations

CN (1)