A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Dato-DXd: Dato-DXd will be administered as IV infusion.
Osimertinib: Osimertinib will be administered orally.
Pemetrexed: Pemetrexed will be administered as IV infusion.
Carboplatin: Carboplatin will be administered as IV infusion.
Cisplatin: Cisplatin will be administered as IV infusion.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically or cytologically confirmed non-squamous NSCLC.
* Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutations, which may include T790M).
* Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
* Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
* At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow reserve and organ function within 7 days before randomization.
Exclusion Criteria:
* Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
* Has significant third-space fluid retention (example \[eg.\], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
* History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
* Unstable spinal cord compression and/or unstable brain metastases.
* Participants with symptomatic brain metastases (including leptomeningeal involvement).
* Clinically significant corneal disease.
* Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. Use of systemic antibiotics within 14 days of randomization.
* Has known human immunodeficiency virus (HIV) infection that is not well controlled.
Primary outcome measure(s)
Progression free Survival (PFS) — Up to 2.5 years 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.
Trial sites (303)
Facility
City
Region
Status
Research Site
Fayetteville
Arkansas
Recruiting
Research Site
Duarte
California
Withdrawn
Research Site
Fountain Valley
California
Recruiting
Research Site
La Jolla
California
Recruiting
Research Site
Los Angeles
California
Withdrawn
Research Site
San Diego
California
Recruiting
Research Site
Colorado Springs
Colorado
Recruiting
Research Site
Fort Collins
Colorado
Recruiting
Research Site
Washington D.C.
District of Columbia
Not Yet Recruiting
Research Site
Gainesville
Florida
Withdrawn
Research Site
Jacksonville
Florida
Recruiting
Research Site
Athens
Georgia
Recruiting
Research Site
Chicago
Illinois
Recruiting
Research Site
Evanston
Illinois
Recruiting
Research Site
Louisville
Kentucky
Recruiting
Research Site
Baltimore
Maryland
Recruiting
Research Site
Bethesda
Maryland
Recruiting
Research Site
Boston
Massachusetts
Withdrawn
Research Site
Boston
Massachusetts
Recruiting
Research Site
Detroit
Michigan
Recruiting
Research Site
Kansas City
Missouri
Recruiting
Research Site
Omaha
Nebraska
Recruiting
Research Site
Morristown
New Jersey
Recruiting
Research Site
Northfield
New Jersey
Recruiting
Research Site
New York
New York
Withdrawn
Research Site
New York
New York
Recruiting
Research Site
The Bronx
New York
Recruiting
Research Site
Maumee
Ohio
Recruiting
Research Site
Philadelphia
Pennsylvania
Withdrawn
Research Site
Pittsburgh
Pennsylvania
Recruiting
Research Site
Chattanooga
Tennessee
Recruiting
Research Site
Nashville
Tennessee
Recruiting
Research Site
Fairfax
Virginia
Recruiting
Research Site
Seattle
Washington
Withdrawn
Research Site
Fitzroy
Australia
Recruiting
Research Site
Heidelberg
Australia
Recruiting
Research Site
Kogarah
Australia
Recruiting
Research Site
Liverpool
Australia
Recruiting
Research Site
Nedlands
Australia
Recruiting
Research Site
Port Macquarie
Australia
Recruiting
+ 263 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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