LOGIK2002(RESTART)

JRCT ID: jRCTs071200102

Registered date:25/02/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Treatment-naive advanced non-squamous non-small cell lung cancer
• Date of first enrollment: 18/03/2021
• Target sample size: 25
• Study type: Interventional

Intervention(s)

CBDCA AUC5(day1)+nab-Paclitaxel 100mg/m2(day1,8,15)+
Atezolizumab 1200mg/body(day1), every 3 weeks, up to 4 cycles.
Atezolizumab 1200mg/body (day1), every 3 weeks, up to PD.

Outcome(s)

• Primary Outcome: Response proportion(Response rate)

Secondary Outcome

PFS(Progression-free survival)
Overall survival
DOR(Duration of response)
TTF(Time-to-treatment-failure)
Dose intensity/Relative dose intensity
Safety(Adverse events of any grade,Incidence of treatment-related deaths,Incidence of early deaths,Non-hematological adverse events of grade4,Incidence of Grade4renal events)

Key inclusion & exclusion criteria

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

Include criteria

(1) Cytologically or histologically confirmed non-squamous non-small cell lung cancer.
(2) Clinical stage III without indication of definitive thoracic radiotherapy, stage IV, postoperative recurrent disease, or recurrence after radiation therapy.
(3) Either (i) or (ii) for prior treatment.
(i) A patient who is negative or unknown for driver genetic mutations must meet the following criteria:
a) Active EGFR mutation is negative.
b) ALK, ROS1, BRAF (V600E), MET, RET, NTRK mutation are negative or unknown.
No prior systemic chemotherapy.
(ii) A driver genetic mutation-positive patient must meet the following criterion:
Confirmed progression after at least one line of targeted therapy for each driver mutation and no other prior systemic therapy. At least 7 days since last molecularly targeted therapy at the start of protocol therapy.
(4) No prior drug therapy that specifically target the T cell co-stimulation or checkpoint pathway, such as anti-PD-1 antibody, anti-PD-L1 antibody, and anti-CTLA-4 antibody.
(5) measurable lesion
(6) Over 20 years old.
(7) Performance status 0 or 1.
(8) No symptomatic brain metastasis.
(9) If the following prior treatment is performed before registration, the specified period has passed since the end of the treatment.
(i) No prior stereotactic irradiation and Gamma-knife for central nervous system metastases within one day.
(ii) No prior whole-brain irradiation within 7 days.
(iii) No prior palliative radiation therapy for non-central nervous system metastases within 7 days.
(iv) No prior pleural drainage within 7 days.
(v) No prior surgery with general anesthesia within 14 days.
(10) Adequate organ function other than kidney.
(i) Neutrophil count >= 1,500/mm3
(ii) Hemoglobin >= 9.0 g/dL
(iii) Platelet count >= 100,000/mm3
(iv) AST, ALT =<100 IU/L(cases with liver metastases AST, ALT =<200 IU/L)
(v) T.bil =< 1.5 mg/dL
(vi) Creatinine clearance:over 15 mL/min and less than 45 mL/min, excluding hemodialysis patients.
(11) Written informed consent.

Exclude criteria

(1) Synchronous double or multiple cancer or metachronous double or multiple cancer within 2 years.
(2) Infectious disease requiring systemic treatment.
(3) Active hepatitis B and active hepatitis C.
(4) Findings suggestive of interstitial lung disease or pulmonary fibrosis on the chest computed tomography.
(5) Active autoimmune disease.
(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
(7) Has serious complications.
(i) Frequent transient ischemic attacks.
(ii) Symptomatic congestive heart failure, unstable angina, or a history of myocardial infarction within a year.
(iii) Clinically serious arrhythmia on the electrocardiogram.
(iv) Gastrointestinal perforation, fistula, diverticulitis within a year.
(v) Uncontrollable peptic ulcer.
(vi) Diabetes mellitus uncontrollable with the appropriate treatment.
etc.
(8) Grade 2 or higher peripheral neuropathy.
(9) Hypersensitivity to the ingredients / additives of carboplatin, nab-paclitaxel, and atezolizumab.
(10) Psychological disorder difficult to participate in this clinical study.
(11) During pregnancy, within 28 days of postparturition, or during lactation.
(12) Other cases that the doctor considers inappropriate.

Related Information

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