Non-small cell lung cancer with EGER mutation (1st line therapy)
Conditions
Interventions
investigational material(s)
Generic name etc : R1415(Erlotinib hydrochloride)
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for In
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -EGFR activating mutations (exon 19 del. Exon 21 L858R) -Histologically and/or cytologically demonstrated to have non-small cell lung cancer other than squamous cell carcinoma. -Stage III, IV or recurrent NSCLC -Has not undergone chemotherapy -Patients who have had undergone radiotherapy are acceptable if patients meet all of the following criteria: *No history of irradiation to pulmonary tumor lesions. *In case of palliative irradiation to bone lesions in lung: at least 12 weeks must have passed at the date of registration since the last irradiation of the sites. *In case of irradiation to non-pulmonary sites: at least two weeks must have passed at the date of inclusion since the last irradiation of the sites. -At the time of registration, at least the following period has passed since last date of the prior therapy or procedure. *Surgery (including exploratory/ examination thoracotomy) : 4 weeks *Pleural cavity drainage: 2 weeks *Pleurodesis without anti-neoplastic agents (inclusive of BRM such as Picibanil): 2 weeks *Biopsy accompanied by incision (including thoracoscopic biopsy) : 2 weeks *Procedure for trauma (exclusive of patients with unhealed wound) : 2 weeks *Transfusion of blood, preparation of hematopoietic factor: 2 weeks *Puncture and aspiration cytology:1 week *Other investigational product: 4 weeks -ECOG PS 0-1 -Adequate organ function -Informed consent
Exclusion criteria
Exclusion criteria: -EGFR mutation (Exon 20 T790M) -Brain metastases. -History or presence of hemoptysis or bloody sputum listed below(hemorrhage from the respiratory apparatus 2.5 cc or more). *Consecutive bloody sputum (for more than a week) or its history. *Bloody sputum that requires consecutive medication with oral anastaltic. *Bloody sputum that requires administering intravenous injectable anastaltic. -Presence of bleeding tendency (coagulation disorder). -Tumor invasion or abutting major blood vessels is clearly detected on image. -Cavitation of pulmonary tumor lesion is apparently detected on the image. -Co-existence or history of interstitial lung disease clearly detected by imaging. -Co-existence of superior vena cava syndrome (SVCS). -Co-existence of symptomatic cerebrovascular disorder, or its history within 1 year before registration. -Co-existence of corneal disease representing a problem clinically -Patients clearly have intestinal diverticulum -Co-existence or history of gastrointestinal perforation within 1 year before registration -Presence of cardiac disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS) According to RECIST ver1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, one year survival rate, tumor response (objective response rate, disease control rate and duration of response), QOL , and safety profile. According to RECIST ver1.1 and NCI-CTC ver4.03 (Safety) and FACT-L(QOL) | — |
Outcome results
None listed