This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
324
orally, 300 mg, once daily until a treatment discontinuation criterion is met.
Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.
OPN Healthcare, Inc.
Glendale, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
BRCR Medical Center Inc.
Plantation, Florida, United States
Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
Time frame: Up to approximately 34 months after the first participant is randomized
Overall Survival
Time frame: Up to approximately 34 months after the first participant is randomized
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
OSU Brain & Spine Hospital
Columbus, Ohio, United States
...and 150 more locations