A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

Key facts

Study ID: NCT04351555
Run by: AstraZeneca
People needed: 358
Starts: 2020-12-16
Expected to finish: 2029-06-13
Last updated by the study team: 2026-06-05

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female, at least 18 years of age. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).
Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
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 (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q).

You may not qualify if…

Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
History of another primary malignancy (including any known or suspected synchronous primary lung cancer), except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease; Any synchronous Stage IA primary lung cancer that is ≤2 cm and planned to be resected during surgery for the Stage II to IIIB N2 lung tumour.
Patients who have pre-operative radiotherapy treatment as part of their care plan
Mixed small cell and NSCLC histology
Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC
T4 tumours infiltrating the great vessels, the carina, the trachea, the oesophagus, the heart, and/or the vertebral body; and/or any bulky N2 disease.
Patients who are candidates to undergo only segmentectomies or wedge resections
Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
Prior treatment with EGFR-TKI therapy
Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)

Where it is running

Research Site — Irvine, California, United States
Research Site — San Francisco, California, United States
Research Site — Santa Monica, California, United States
Research Site — Santa Rosa, California, United States
Research Site — Boston, Massachusetts, United States
Research Site — Lebanon, New Hampshire, United States
Research Site — Commack, New York, United States
Research Site — New York, New York, United States
Research Site — Houston, Texas, United States
Research Site — Fairfax, Virginia, United States
Research Site — Seattle, Washington, United States
Research Site — Graz, Austria
Research Site — Vienna, Austria
Research Site — Barretos, Brazil
Research Site — Fortaleza, Brazil
Research Site — Jaú, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Recife, Brazil
Research Site — Rio de Janeiro, Brazil
Research Site — Santa Maria, Brazil
Research Site — São José do Rio Preto, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Duarte, California, United States

Full record on ClinicalTrials.gov

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