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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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Metastatic Non-small Cell Lung Cancer
Date of first enrollment	17/10/2024
Target sample size	77
Countries of recruitment	Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,France,Japan,Germany,Japan,Greece,Japan,India,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Malaysia,Japan,Philippines,Japan,Poland,Japan,Singapore,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,United Kingdom,Japan,United States,Japan,Vietnam,Japan,Hong Kong,Japan,Netherlands,Japan,Romania,Japan
Study type	Interventional
Intervention(s)	Pparticipants will be randomized in a 1:1:1 ratio to receive either Dato DXd combined with osimertinib, Dato-DXd monotherapy, or chemotherapy.

Outcome(s)

Primary Outcome	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.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.