Randomized phase II study of osimertinib plus ramucirumab and osimertinib for chemotherapy-naive patients with nonsquamous non-small cell lung cancer harboring EGFR mutations - TORG1833

Kanagawa Cancer Center0 sites120 target enrollmentOctober 10, 2018

Overview

No summary available.

Registry

who.int

Start Date

October 10, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.

•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