Metastatic Non-small Cell Lung Cancer
Conditions
Interventions
Pparticipants will be randomized in a 1:1:1 ratio to receive either Dato DXd combined with osimertinib, Dato-DXd monotherapy, or chemotherapy.
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the Paliiative. Platinum-based chemotherapy in Curative 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 ILD/pneumonitis including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced 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 IV 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Malaysia, Netherlands, Philippines, Poland, Romania, Singapore, Spain, Taiwan, Thailand, United Kingdom, United States, Vietnam
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed