non-small cell lung cancer
Conditions
Interventions
Experimental group :Icotinib 125mg orally(PO) tid + vinorelbine 40mg po three times weekly (Monday-Wednesday-Friday) continuously until disease progression, unacceptable toxicity or patient refusal.
control group :Icotinib 125mg orally(PO) tid continuously until disease progression, unacceptable toxicity or patient refusal.
Sponsors
Shandong Cancer Hospital and Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The treatment-naive pathologically confirmed Stage IIIB, IIIC or IV nonsquamous non–small-cell lung cancer (American Joint Committee on Cancer version 8); 2. With common activating EGFR mutation (exon 19 deletion or Leu858Arg); 3. at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 4. Eastern Cooperative Oncology Group performance status(ECOG PS) of 0 or 1 and Life expectancy of at least 3 months; 5. Aged 18-75 years old, Male or female; 6. adequate heart, liver and kidney function and normal blood examination; 7. without other serious diseases conflicting with this programme; 8. patients with good compliance and available follow-up.
Exclusion criteria
Exclusion criteria: 1. Women who were pregnant or lactating,women with a positive or no available pregnancy test result at baseline; 2. Have severe organic disease or major organ failure,such as decompensated heart, pulmonary failure, etc. 3. Have serious uncontrolled medical illness or infection; 4. Poorly tolerated patients or psychosensors without self-knowledge; 5. People who can't stop NSAIDS; 6. The investigators considered someone is inappropriate to join.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free servival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective Response Rate;adverse event; | — |
Countries
China
Contacts
Public ContactLiu Jie
Shandong Cancer Hospital and Institute
Outcome results
None listed