OncoMatch/Clinical Trials/NCT06350097
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
Is NCT06350097 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Osimertinib and Datopotamab Deruxtecan for non-small cell lung cancer.
Treatment: Osimertinib · Datopotamab Deruxtecan — 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 9 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
The tumour harbors at least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other genomic alterations, which may include EGFR T790M
Required: EGFR L858R
The tumour harbors at least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other genomic alterations, which may include EGFR T790M
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
WHO 0–1
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Participants must not have received prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC.
Cannot have received: antibody-drug conjugate
Prior exposure to any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase I, TROP2-targeted therapy.
Cannot have received: TROP2-targeted therapy
Prior exposure to any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase I, TROP2-targeted therapy.
Lab requirements
Blood counts
Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.
Kidney function
Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.
Liver function
Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.
Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Fountain Valley, California
- Research Site · Los Alamitos, California
- Research Site · Los Angeles, California
- Research Site · Los Angeles, California
- Research Site · Orange, California
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