Phase II study of carboplatin/nab-paclitaxel/atezolizumab combination therapy for advanced non-squamous NSCLC with impaired renal function - LOGIK2002(RESTART)

Okamoto Isamu0 sites25 target enrollmentFebruary 25, 2021

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Treatment-naive advanced non-squamous non-small cell lung cancer
Sponsor: Okamoto Isamu
Enrollment: 25
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

February 25, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Okamoto Isamu

•(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.

•(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.