LOGIK2004(NIke Study)

JRCT ID: jRCTs071210019

Registered date:11/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced non-small cell lung cancer
• Date of first enrollment: 12/05/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Continue administration of the protocol treatments until meeting the withdrawal criteria of this study.
[protocol treatments]
1.Induction therapy
-non-squamous cell carcinoma
(CBDCA AUC 5 + PEM 500 mg/m^2 + Nivo 360 mg + Ipi 1 mg/kg) x 2 cycles
-squamous cell carcinoma
(CBDCA AUC 6 + PTX 200 mg/m^2 + Nivo 360 mg + Ipi 1 mg/kg) x 2 cycles
2.Maintenance therapy
(Nivo 360 mg + Ipi 1 mg/kg) x until PD or 2years

Outcome(s)

• Primary Outcome: Response rate of brain metastases
• Secondary Outcome: PFS of brain metastases, PFS rate of brain metastases at 3.6.9.12month, Time to brain local site therapy, Local therapy of brain metastases after the progression, Response rate except the brain metastasis, PFS except the brain metastasis, Response rate of all lesions, PFS of all lesions, overall survival (OS), safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.
8) Patients with at least one cerebral metastasis that is at least 5 mm and twice the head MRI slice thickness, that is symptomatic or asymptomatic and does not require urgent local therapy such as radiation or surgical resection at the time of enrollment. Patients with no history of radiation therapy or surgery. No restrictions on the administration period or dose of steroids as anti-edema therapy for brain metastases.
9) Patients may or may not have measurable lesions other than brain metastases.
10) No treatments prior to registration as follows.
If any prior treatment has been performed, the prescribed period has passed since the end (allowed if it is the same day of the week as the registration date) of the treatment.
(1) More than 7 days after palliative radiation for non- central nerve metastases
(2) More than 7days after drainage of pleural or pericardial or abdominal drainage
(3) More than 7 days after surgery with general anesthesia
11)No concurrent auto-immune disease or no history of chronic or recurrent auto-immune disease.
However, controllable auto-immune disease with appropriate treatment is allowed.
12) Adequate organ function
(1)Neutrophil count >= 1,500/mm3
(2)Hemoglobin >=9.0 g/dL
(3)Platelet count >= 100,000/mm3
(4)AST, ALT =< 100 IU/L (cases with liver metastases AST, ALT =< 200 IU/L)
(5)Total bilirubin =< 1.5 mg/dL
(6)Serum creatinine=< 1.5 mg/dL (non-squamous cell carcinoma: creatinine clearance >= 45mL/min)
(7) PaO2 >= 60 torr or SpO2 >= 90%
13) Written informed consent.

Exclude 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.
-Gastrointestinal perforation, fistula, diverticulitis within a year.
-Uncontrollable peptic ulcer.
7) Diabetes mellitus uncontrollable with the appropriate treatment.
8) Grade 2 or higher peripheral neuropathy in squamous cell carcinoma.
9) Hypersensitivity to the ingredients / additives of carboplatin, pemetrexed, paclitaxel, nivolumab, and ipilimumab.
10) Psychological disorder difficult to participate in this clinical study.
11) During pregnancy or during lactation.
12) Other cases that the doctor considers inappropriate

Related Information

• Primary Sponsor: Okamoto Isamu
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.