EGFR mutation-positive non-squamous non-small-cell lung cancer Advanced non-squamous non-small cell lung cancer, EGFR mutation positive
Conditions
Interventions
Osimertinib monotherapy: 80 mg of osimertinib daily. osimertinib plus ramucirumab: 80 mg of osimertinib daily, in combination with osimertinib, 10 mg/kg of body weight of ramucirumab (genetical recomb
D046650
chemotherapy
Sponsors
Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological or cytological diagnosis of non-squamous non-small-cell lung cancer 2) Histological or cytological evidence of EGFR mutation (exon 19 deletion or L858R) 3) Stage IIIB, IIIC or IV disease not treatable with radical radiotherapy, or postoperative recurrent disease (UICC-TNM Classification, 8th edition) 4) No symptomatic brain metastasis. Brain metastasis is acceptable if neurological recovery (CTCAE v4.0 Grade 0-1 or equivalent) following radiation treatment has been maintained for at least 2 weeks before enrollment 5) Aged 20 years or older at the time of informed consent 6) ECOG performance status (PS): 0 or 1 7) Has measurable lesion(s) as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, excluding irradiated lesions 8) Previously untreated with drug therapy for lung cancer (including EGFR-TKIs and immune checkpoint inhibitors), excluding preoperative or postoperative chemotherapy completed at least 6 months before enrollment in the study 9) No severe damage to major organs and satisfying the specified criteria 10) Female patients of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to first dose of protocol therapy. 11) Has given written informed consent to participate in the study after receiving detailed explanation of the study before enrollment in the study.
Exclusion criteria
Exclusion criteria: 1) Known T790M EGFR mutation 2) Active double cancer (synchronous double cancer or metachronous double cancer with a 5-year or shorter disease-free period, excluding lesions such as carcinoma in situ and intramucosal carcinoma) 3) The patient has a history of gross hemoptysis (defined as the presence of >= 1/2 teaspoon of gross blood) within 2 months prior to enrollment. 4) The patient has radiographic evidence of intratumor cavitation, regardless of tumor histology. 5) Likely to have any concurrent disease associated with bleeding 6) The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted. 7) Active infection 8) The patient is pregnant or breast-feeding, reject contraception. 9) SPO2 < 94% (room air) 10) Clinically significant psychiatric disease 11) Requiring continuous systemic steroid therapy at a prednisolone equivalent dose higher than10 mg/day or receiving an immunosuppressant 12) History of serious hypersensitivity to osimertinib or ramucirumab 13) Active hepatic impairment (HBs antigen positive, HBV-DNA positive, alcoholic hepatitis, autoimmune hepatitis, liver cirrhosis) 14) Symptomatic cerebrovascular disease, interstitial lung disease or other complications, or a history of gastrointestinal perforation, thromboembolism, etc. 15) Orally receiving CYP3A4 inducers (phenytoin, rifampicin, carbamazepine, St.John,s wort) 16) Inappropriate for the study, in the opinion of the investigator, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival(assessed by the central image reviewer) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival(assessed by an attending physician) Objective response rate Disease control rate Duration of response Overall survival Safety and toxicity profile | — |
Countries
Japan
Contacts
Public ContactYoshirou Nakahara
Kitasato University Hospital
Outcome results
None listed