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 (Jun 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
Treatments studied
Targeted therapy
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06350097 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR L858R is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify