TROPION-Lung01 Study Design and Baseline demographics
Daiichi-Sankyo
TROPION-Lung01 Study Design
Randomized, Phase 3, Open-Label, Global Study (NCT04656652)
Key Eligibility Criteria
NSCLC (stage IIIB, IIIC, or IV)
ECOG PS of 0 or 1
•
No prior docetaxel
Without actionable genomic alterationsª
Dato-DXd
6 mg/kg Q3W
(N=299)
• 1 or 2 prior lines, including platinum CT and
anti-PD-(L)1 mAb therapy
With actionable genomic alterations
• Positive for EGFR, ALK, NTRK, BRAF, ROS1.
•
MET exon 14 skipping, or RET
1 or 2 prior approved targeted therapies +
platinum-based CT, and ≤1 anti-PD-(L)1 mAb
Enrollment period: 19 February 2021 to 7 November 2022.
R 1:1
Docetaxel
Dual Primary Endpoints
•
PFS by BICR
OS
Secondary Endpoints
•
ORR by BICR
•
75 mg/m² Q3W
(N=305)
DOR by BICR
•
Safety
Stratified by: histology, actionable genomic alteration,c
anti-PD-(L)1 mAb included in most recent prior therapy, geographyd
BICR, blinded independent central review, CT, chemotherapy; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; mAb, monoclonal antibody; NSCLC, non-small cell lung cancer,
ORR, objective response rate; OS, overall survival; PD-(L)1, programmed cell death 1 (ligand 1); PFS, progression-free survival; Q3W, every 3 weeks; R, randomized.
*Patients with KRAS mutations in the absence of known actionable genomic alterations are eligible; must meet prior therapy requirements for patients without actionable genomic alterations. "Squamous vs non-squamous.
*Presence vs absence. "United States/Japan/Western Europe vs rest of world.
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