At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically or cytologically confirmed nonsquamous NSCLC (adenocarcinoma predominant if mixed)
- ✓Stage IIIB, IIIC, or Stage IV metastatic NSCLC or recurrent NSCLC not amenable to curative surgery or definitive chemoradiation
- ✓At least one RECIST 1.1 measurable target lesion ≥10 mm (lymph nodes ≥15 mm short axis), not previously irradiated
- ✕Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant of NSCLC
- ✕Prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC, or IV NSCLC
- ✕Severe or uncontrolled systemic diseases, active bleeding diseases, history of allogeneic organ transplant
- ✕Refractory nausea/vomiting, chronic GI disease, inability to swallow, or previous significant bowel resection affecting absorption
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Osimertinib and Datopotamab Deruxtecan for Non-small Cell Lung Cancer. Currently recruiting, targeting 582 participants across 166 sites in 19 countries.
Signals
Detailed Summary
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC. Study details include: 1. The study duration will be event-driven, with an estimated duration of approximately 8 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period. Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.
Study Details
Timeline
Interventions
Osimertinib 80 mg administered orally once daily (QD).
Datopotamab Deruxtecan 6 mg/kg administered as an intravenous (i.v.) infusion every 3 weeks (q3w).