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

Recruiting · NCT06417814 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

Carboplatin Cisplatin Dato-DXd Osimertinib Pemetrexed

What this trial is about

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).

Who can take part

Age range

18 Years to 130 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 20 US states.

Research Site - Fayetteville, Arkansas, United States
Research Site - Duarte, California, United States
Research Site - Fountain Valley, California, United States
Research Site - La Jolla, California, United States
Research Site - Los Angeles, California, United States
Research Site - San Diego, California, United States
Research Site - Colorado Springs, Colorado, United States
Research Site - Fort Collins, Colorado, United States
Research Site - Washington D.C., District of Columbia, United States
Research Site - Gainesville, Florida, United States
Research Site - Jacksonville, Florida, United States
Research Site - Athens, Georgia, United States
Research Site - Chicago, Illinois, United States
Research Site - Evanston, Illinois, United States
Research Site - Louisville, Kentucky, United States
Research Site - Baltimore, Maryland, United States
Research Site - Bethesda, Maryland, United States
Research Site - Boston, Massachusetts, United States
Research Site - Boston, Massachusetts, United States
Research Site - Detroit, Michigan, United States
Research Site - Kansas City, Missouri, United States
Research Site - Omaha, Nebraska, United States
Research Site - Morristown, New Jersey, United States
Research Site - Northfield, New Jersey, United States
Research Site - New York, New York, United States
Research Site - New York, New York, United States
Research Site - The Bronx, New York, United States
Research Site - Maumee, Ohio, United States
Research Site - Philadelphia, Pennsylvania, United States
Research Site - Pittsburgh, Pennsylvania, United States
Research Site - Chattanooga, Tennessee, United States
Research Site - Nashville, Tennessee, United States
Research Site - Fairfax, Virginia, United States
Research Site - Seattle, Washington, United States
Research Site - A Coruña, Spain
Research Site - Alor Star, Malaysia
Research Site - Amersfoort, Netherlands
Research Site - Amravati, India
Research Site - Amsterdam, Netherlands
Research Site - Angers, France
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Avignon, France
Research Site - Bacolod, Philippines
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Baoding, China
Research Site - Barakaldo, Spain
Research Site - Barcelona, Spain
Research Site - Barcelona, Spain
Research Site - Bari, Italy
Research Site - Barretos, Brazil
Research Site - Beersheba, Israel
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Beijing, China

Showing 60 of 303 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →