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)
Disease-Free Survival (DFS) in high-risk stratum — From date of randomisation up to approximately 10 years DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.
Stratification to the high risk stratum will be based on pathologic features assessed by central pathology review during screening.
Trial sites (139)
Facility
City
Region
Status
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.
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.
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