Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer

Plasma EGFR Mutation-positive Lung Cancer Clinical Trial

— CHALLENGE  

Official title:

Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer：a Single Arm，Multi-center，Open-label Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03346811
• Other study ID #: BD-IC-IV90
• Status: Recruiting
• Phase: Phase 2
• First received: November 15, 2017
• Last updated: November 15, 2017
• Start date: November 18, 2017
• Est. completion date: March 10, 2020

Study information

• Verified date: November 2017
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Jie Wang, MD
• Phone: 13910704669
• Email: zlhuxi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this single arm，open-label，multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 10, 2020
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear.

• Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS,any positive).

• unavailable of radical surgery or radical radiotherapy.

• not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc.

• Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy.

• Age 18-75 years old with performance status of 0 to 3.

• With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions.

• Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

• Evidence of interstitial lung diseases

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

• Other situations researchers think not appropriate to enter the group

Related Conditions & MeSH terms

• Lung Neoplasms
• Plasma EGFR Mutation-positive Lung Cancer

Intervention

Drug:
• Icotinib
Patients with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Response Rate	12 weeks
Secondary	PFS	Progression-free survival	12 months
Secondary	DCR	disease control rate	12 months
Secondary	OS	overall survival	20 months