This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
This is a Phase III, open-label, 3-arm, multicenter study assessing the effects of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in participants with epidermal growth factor receptor gene mutation (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on prior osimertinib treatment. Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups: 1. Dato-DXd + osimertinib combination therapy 2. Dato-DXd monotherapy 3. Platinum-based doublet chemotherapy Participants will receive study intervention until Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) -defined radiological progression by the investigator, unacceptable toxicity, or other discontinuation criterion is met. After study intervention discontinuation, all participants will undergo an end of treatment (EoT) visit within 35 days of discontinuation and will be followed up for safety assessments 28 (+ 7) days after their last dose of study intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
744
Dato-DXd will be administered as IV infusion.
Osimertinib will be administered orally.
Pemetrexed will be administered as IV infusion.
Progression free Survival (PFS)
PFS is defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression.
Time frame: Up to 2.5 years
Overall Survival (OS)
OS is defined as time from randomization until the date of death due to any cause.
Time frame: Up to 3.5 years
Central Nervous System Progression-free Survival (CNS PFS)
CNS PFS is defined as the time from randomization to BICR confirmed progression in the CNS or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinically progresses prior to BICR confirmed CNS modified RECIST v1.1 progression.
Time frame: Up to 2.5 years
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by BICR per RECIST v1.1.
Time frame: Up to 2.5 years
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, as assessed by BICR or death due to any cause.
Time frame: Up to 2.5 years
Progression-free Survival-2 (PFS-2)
PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial investigator assessed progression), after first subsequent therapy, or death.
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Carboplatin will be administered as IV infusion.
Cisplatin will be administered as IV infusion.
Research Site
Fayetteville, Arkansas, United States
RECRUITINGResearch Site
Duarte, California, United States
NOT_YET_RECRUITINGResearch Site
Fountain Valley, California, United States
RECRUITINGResearch Site
La Jolla, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
NOT_YET_RECRUITINGResearch Site
San Diego, California, United States
NOT_YET_RECRUITINGResearch Site
Colorado Springs, Colorado, United States
RECRUITINGResearch Site
Fort Collins, Colorado, United States
RECRUITINGResearch Site
Gainesville, Florida, United States
NOT_YET_RECRUITINGResearch Site
Jacksonville, Florida, United States
RECRUITING...and 290 more locations
Time frame: Up to 3.5 years
Objective Response Rate (ORR) Using CNS Modified RECIST v1.1
ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, using CNS modified RECIST v1.1.
Time frame: Up to 2.5 years
Duration of Response (DoR) Using CNS Modified RECIST v1.1
DoR is defined as the time from the date of first documented response until date of documented progression or death due to any cause using CNS modified RECIST v1.1.
Time frame: Up to 2.5 years
Time to Deterioration in Pulmonary Symptoms
Time to deterioration (in pulmonary symptoms \[dyspnea, cough, and chest pain\]) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.
Time frame: Up to 3.5 years
Time to Deterioration in Physical Functioning
Time to deterioration in physical functioning as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 8c will be evaluated. Time to deterioration (in physical functionating) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.
Time frame: Up to 3.5 years
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL)
Time to deterioration in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172 will be reported. Time to deterioration (in GHS/QoL) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.
Time frame: Up to 3.5 years
Pharmacokinetics (PK) of Dato-DXd
Concentration of Dato-DXd, total anti-TROP2 antibody and DXd in plasma.
Time frame: Up to 3.5 years
Immunogenicity of Dato-DXd
Presence of antidrug antibody (ADAs) for Dato-DXd (confirmatory results: positive or negative, titers).
Time frame: Up to 3.5 years