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

Betta Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Plasma EGFR Mutation-positive Lung Cancer

Treatments: Drug: Icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03346811

BD-IC-IV90

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Experimental: icotinib

Experimental group

Description:

Patients diagnosed with lung cancer 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

Treatment:

Drug: Icotinib