OncoMatch/Clinical Trials/NCT05011487
Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC
Is NCT05011487 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Osimertinib and Cisplatin for non-small cell lung cancer.
Treatment: Osimertinib · Cisplatin · Pemetrexed — This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR ex19del
A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).
Required: EGFR L858R
A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).
Disease stage
Required: Stage IIIA, T3-4N2 IIIB (IASLC Version 8)
Excluded: Stage T4 TUMOURS INFILTRATING THE AORTA, THE OESOPHAGUS AND/OR THE HEART, ANY BULKY N2 DISEASE DEEMED UNRESECTABLE
resectable (Stage IIIA or T3-4N2 IIIB) disease (according to Version 8 of the IASLC Cancer Staging Manual)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic anti-cancer therapy
Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
Cannot have received: EGFR tyrosine kinase inhibitor
Prior treatment with EGFR-TKI therapy
Cannot have received: radiation therapy
Exception: pre-operative only
Patients who have pre-operative radiotherapy treatment as part of their care plan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05011487 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 ex19del 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 IIIA or T3-4N2 IIIB is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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