NEJ043

JRCT ID: jRCTs031190066

Registered date:01/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-sequamous non-small cell lung cancer
• Date of first enrollment: 02/09/2019
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Induction therapy: atezolizumab 1200 mg/body day1 + carboplatin AUC 6 day1+ paclitaxel 175 mg/m2 day1 + bevacizumab 15 mg/kg day1 q3w.
Maintenance therapy: atezolizumab 1200 mg/body day1 + bevacizumab 15 mg/kg day1 q3w.

Outcome(s)

• Primary Outcome: Progression-Free Survival
• Secondary Outcome: Overall survival, Objective response rate, Duration of response, Safety, relative dose intensity of paclitaxel, the efficacy of atezolizumab + carboplatin + paclitaxel + bevacizumab in each type of EGFR-TKIs and EGFR-mutations,PD-L1,and biomarker analysis.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both
• Include criteria: 1) Stage III or IV Non-Squamous, non-small cell lung cancer proven by histology and/or cytology without indication of curative surgery or curative radiotherapy, 2) Sensitizing EGFR mutations (19 deletion, L858R, G719X, S768I, L861Q, T790M), 3) Prior therapy with EGFR-TKIs, 4) Measurable disease, as defined by RECIST ver 1.1, 5) No prior cytotoxic chemotherapy or immunotherapy, 6) 20 years or older, 7) ECOG PS 0 or 1, 8) adequate hematologic and end organ function, 9) Written informed consent form.
• Exclude criteria: 1) History of interstitial lung disease or radiation pneumonitis, 2) Symptomatic CNS metastases, CNS metastases treated with corticosteroids, leptomeningeal disease, 3) Irradiation for primary tumor or target lesion defined by RECIST ver 1.1, 4) Uncontrolled heart, lung, liver, renal diseases, 5) History of autoimmune diseases, 6) Known hypersensitivity or allergy to paclitaxel or polyoxyethylene castor oil containing formulations, 7) History of hemoptysis, 8)Invasion to major vessels or heart, 9) Treatment with systemic corticosteroid or immunosuppressant, 10) Patients with active hepatitis B or hepatitis C or positive for HIV test, 11) Women who are pregnant, lactating, or intending to become pregnant during the study, 12) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, 13) Malignancies other than NSCLC within 5 years, 14) History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, 15) Plan for major surgical procedure during the course of the study.

Related Information

• Primary Sponsor: Kikuchi Toshiaki
• Secondary Sponsor: Nonprofit Organization, North East Japan Study Group