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Clinical Trials in China / NCT05120349
Active, not recruiting Phase 3

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

NCT05120349 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-02-21
Last updated
2026-07-06

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

OsimertinibPlacebo

Osimertinib: The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease recurrence, unacceptable toxicity or other discontinuation criteria are met.

Placebo: Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.

Study summary

This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria 1. Male or female, at least ≥ 18 years. 2. NSCLC, of non-squamous histology. 3. Stage IA2 or IA3 disease, based on TNM8 classification. 4. Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection. 5. Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants. 6. World Health Organization performance status of 0 or 1. 7. Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation. 8. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test. 9. Minimum life expectancy of \> 6 months. 10. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception. Exclusion Criteria 1. Mixed small cell and non-small cell cancer history. 2. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection. 3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including HCV and HIV or active uncontrolled HBV infection. 4. History of another primary malignancy, including any known or suspected synchronous primary lung cancer except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence. 5. Any of the following cardiac criteria: * Mean resting QTcF interval \> 470 ms, obtained from triplicate ECGs performed at screening. * Any abnormalities in rhythm, conduction, or morphology of resting ECG, * Any factors that increase the risk of QTcF prolongation or risk of arrhythmic events. 6. History of interstitial lung disease. 7. Inadequate bone marrow reserve or organ function. 8. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention. 9. Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs). 10. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention. 11. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.

Primary outcome measure(s)

Trial sites (139)

FacilityCityRegionStatus
Research Site Anchorage Alaska
Research Site Los Angeles California
Research Site Orange California
Research Site Grand Junction Colorado
Research Site Newark Delaware
Research Site Atlanta Georgia
Research Site Chicago Illinois
Research Site Frederick Maryland
Research Site Morristown New Jersey
Research Site Flushing New York
Research Site New York New York
Research Site New York New York
Research Site White Plains New York
Research Site Houston Texas
Research Site Fort Belvoir Virginia
Research Site Buenos Aires Argentina
Research Site CABA Argentina
Research Site Cipolletti Argentina
Research Site La Plata Argentina
Research Site Rosario Argentina
Research Site Rosario Argentina
Research Site S.C. de Bariloche Argentina
Research Site Barretos Brazil
Research Site Belo Horizonte Brazil
Research Site Porto Alegre Brazil
Research Site Recife Brazil
Research Site Rio de Janeiro Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Vancouver British Columbia
Research Site Montreal Quebec
Research Site Toronto Canada
Research Site Beijing China
Research Site Beijing China
Research Site Beijing China
Research Site Beijing China
Research Site Beijing China
Research Site Beijing China
Research Site Changchun China
Research Site Changsha China

+ 99 more sites — see the full list on the official registry below.

On this site

📄 Tagrisso (osimertinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05120349 on ClinicalTrials.gov ↗ ← All trials in China