LOGIK2102

JRCT ID: jRCTs071220008

Registered date:27/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: TTF-1 negative treatment-naive advanced non-squamous non-small cell lung cancer
• Date of first enrollment: 12/07/2022
• Target sample size: 52
• Study type: Interventional

Intervention(s)

CBDCA AUC 6 (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: PFS: Progression-free survival

Secondary Outcome

Overall survival
Response proportion
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)

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) No prior systemic chemotherapy.
(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) Has a lesion on imaging. (With or without measurable lesion)
(6) Over 20 years old.
(7) Performance status 0 or 1.
(8) No driver-oncogene alterations.
(9) TTF-1 is negative for IHC
(10) No symptomatic brain metastasis.
(11) 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.
(12) Adequate organ function.
(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) Serum creatinine =< 1.5 mg/dL
(13) 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.
(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.
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.