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

• Status: Unknown status
• Trial end date: 2020-03-10
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

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