JPRN-jRCTs071210019
Recruiting
Phase 2
Phase II Study of Nivolumab, Ipilimumab (checkpoint inhibitors),Platinum Combination Chemotherapy for Treatment-naive Advanced Non-Small Cell Lung Cancer with Untreated Brain Metastases (NIke Study) - LOGIK2004(NIke Study)
Okamoto Isamu0 sites30 target enrollmentMay 11, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Okamoto Isamu
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients with non\-small cell lung cancer (NSCLC) confirmed by histological or cytological diagnosis\*1\.
- •2\) The clinical stage corresponds to any of the following (1\) to (3\).
- •(1\) Stage IV
- •(2\) Postoperative recurrence.
- •(3\) Recurrence more than 168 days (24 weeks) after the last radical body radiotherapy.
- •3\) No history of systemic drug therapy for NSCLC.
- •4\) For non\-squamous cell carcinoma, EGFR mutation is negative. (For squamous cell carcinoma, EGFR mutation analysis is not required)
- •5\) ALK translocation, ROS1 translocation, BRAF (V600E) mutation, MET exon 14 skipping mutation, RET translocation, NTRK translocation are negative or unknown.
- •6\) Patients aged 20 years or older at the time of consent.
- •7\) ECOG performance status 0 or 1\.
Exclusion Criteria
- •1\) Active multiple primary cancers.
- •2\) Local or systemic active infections that require surgical intervention, such as drainage.
- •3\) Active hepatitis B and active hepatitis C.
- •4\) Obvious interstitial lung disease on chest CT at enrollment.
- •5\) Continuous systemic administration of steroids at doses higher than 10 mg / day in terms of prednisolone, or immunosuppressive drugs, for other than anti\-edema therapy for brain metastases.
- •6\) Has serious complications.
- •\-Brain infarction within a year.
- •\-Frequent transient ischemic attacks.
- •\-Symptomatic congestive heart failure, unstable angina, or a history of myocardial infarction within a year.
- •\-Clinically serious arrhythmia on the electrocardiogram.
Outcomes
Primary Outcomes
Not specified
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