Advanced non-small cell lung cancer
Conditions
Interventions
Experimental arm:Afatinib
Afatinib 40mg or 30mg daily until disease progression
(Investigators can choice a 30mg or 40mg dose of afatinib according to patients condition)
Standard arm: Cisplatin(CDDP)
Sponsors
TANAKA Hiroshi
MIURA Satoru
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically and/or cytologically documented non-squamous, non-small cell lung cancer patients with stage IIIB, IIIC or IV, and who are ineligible for curative radiotherapy, or relapsed after postoperative chemotherapy or chemoradiotherapy for locally advanced disease. 2) Sensitizing EGFR Uncommon mutation patient ((1).or(2) with(3)) (1) Patient with EGFR uncommon mutations (2) Patient with compound mutations (3) Patient without resistant EGFR uncommon mutation (T790M, Exon 20 insertions) 3) No prior therapy with chemotherapy, molecular targeted therapy and immune-check point inhibitors 4) 20 years or older 5) ECOG PS 0 or 1 6) Adequate organ function 7) Patients with at least one evaluable lesion (regardless of whether lesions can be measured using RECIST version 1.1) 8) Life expectancy more than three months 9) Written informed consent for translational research Written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients who are difficult to treat enrolled doses due to toxicity of afatinib 2)History of drug-induced pneumonitis/Interstitial pneumonia detectable with chest CT scan. 3)Symptomatic brain metastasis/ leptomeningitis 4)Bone metastasis to treat by operation or radiation therapy 5)Uncontrollable pleural, peritoneal or pericardial effusion 6)Prior thoracic palliative radiotherapy within 2wks 7)SCLC transformation 8)History of active double cancer 9)Severe infection 10)Active HBV infection 11)No intention to birth control 12)Unstable psychic disorder 13)Under treatment of steroid therapy or immunosuppressive therapy 14)History of allergic reaction Decision of ineligibility by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, Overall survival, Time to treatment failure, Safety | — |
Contacts
Public ContactSatoru MIURA
Niigata Cancer Center Hospital
Outcome results
None listed