This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
501
Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.
Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.
Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.
Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
Paclitaxel will be administered at 200 milligrams per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
Alabama Oncology
Birmingham, Alabama, United States
Highlands Oncology Group
Rogers, Arkansas, United States
cCare
Encinitas, California, United States
Kaiser Permanente - Oakland
Oakland, California, United States
Desert Hematology Oncology Group
Rancho Mirage, California, United States
Progression-free Survival (PFS)
Time frame: Up to approximately 2.5 years
PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification
Time frame: Up to approximately 2.5 years
PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low
Time frame: Up to approximately 2.5 years
Objective Tumor Response
Time frame: Up to approximately 2.5 years
Objective Tumor Response in Participants with PIK3CA Amplification
Time frame: Up to approximately 2.5 years
Objective Tumor Response in Participants with PTEN Loss/low
Time frame: Up to approximately 2.5 years
Duration of Objective Response (DoR)
Time frame: Up to approximately 2.5 years
DoR in Participants with PIK3CA Amplification
Time frame: Up to approximately 2.5 years
DoR in Participants with PTEN Loss/low
Time frame: Up to approximately 2.5 years
Overall Survival (OS)
Time frame: Up to approximately 2.5 years
OS in Participants with PIK3CA Amplification
Time frame: Up to approximately 2.5 years
OS in Participants with PTEN Loss/low
Time frame: Up to approximately 2.5 years
Percentage of Participants with Adverse Events
Time frame: Up to approximately 4 years
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Kaiser Permanente - Roseville
Roseville, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
Southern CA Permanente Med Grp
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
K. Permanente - Santa Clara
Santa Clara, California, United States
...and 110 more locations