A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)
Osimertinib 80 mg/40 mg: Participants will receive osimertinib (80 mg or 40 mg orally, once daily).
Study summary
To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria:
1. Male or female aged at least 18 years.
2. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
3. Magnetic Resonance Imaging (MRI) or contrast computed tomography (CT) scan of the brain.
4. Participants must be classified post-operatively as Stage II, IIIA, or IIIB on the basis of surgical pathologic criteria.
5. Confirmation by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR mutation resulting in substitution of threonine with methionine at amino acid position 790 in exon 20 of EGFR (T790M) or uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort).
6. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
7. Complete recovery from surgery and standard post-operative therapy (if applicable) at start of study intervention.
8. World Health Organisation Performance Status of 0 to 1.
9. Female participants must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential.
10. Male participants must use effective barrier contraception.
Exclusion Criteria:
1. Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study drug.
2. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to first dose).
3. Participants who have had only segmentectomies or wedge resections.
4. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer, or other solid tumours curatively treated with no evidence of disease for \> 5 years before the start of study intervention.
5. Treatment with any of the following:
* Pre-operative or post-operative or planned radiation therapy for the current lung cancer.
* Pre-operative (neo-adjuvant) platinum-based or other chemotherapy.
* Any prior anti-cancer or immunological therapy, including investigational therapy, for treatment of NSCLC other than standard platinum-based doublet post-operative adjuvant chemotherapy.
* Prior treatment with neoadjuvant or adjuvant EGFR tyrosine kinase inhibitor (TKI).
6. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib.
7. Any of the following cardiac criteria:
* Mean resting corrected QT (QTc) interval \> 470 msec, obtained from 3 electrocardiograms (ECGs).
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
* Heart failure, congenital long QT interval (QT) syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes (TdP).
8. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
9. Inadequate bone marrow reserve or organ function.
10. Women who are breastfeeding.
Primary outcome measure(s)
Estimate the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort]. — From date of first dose until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 5 years. Assessed at 5 years. Defined as time from date of first dose until disease recurrence, or death due to any cause in the absence of recurrence.
Trial sites (56)
Facility
City
Region
Status
Research Site
Santa Rosa
California
Research Site
Las Vegas
Nevada
Research Site
White Plains
New York
Research Site
Hong Kong
Hong Kong
Research Site
Hong Kong
Hong Kong
Research Site
Hong Kong
Hong Kong
Research Site
Avellino
Italy
Research Site
Brescia
Italy
Research Site
Lecce
Italy
Research Site
Milan
Italy
Research Site
Naples
Italy
Research Site
Palermo
Italy
Research Site
Peschiera del Garda
Italy
Research Site
Reggio Emilia
Italy
Research Site
Sondrio
Italy
Research Site
Terni
Italy
Research Site
Udine
Italy
Research Site
Kuala Lumpur
Malaysia
Research Site
Kuantan
Malaysia
Research Site
Kuching
Malaysia
Research Site
Cebu
Philippines
Research Site
Manila
Philippines
Research Site
Quezon City
Philippines
Research Site
Singapore
Singapore
Research Site
Busan
South Korea
Research Site
Busan
South Korea
Research Site
Cheongju-si
South Korea
Research Site
Daejeon
South Korea
Research Site
Goyang-si
South Korea
Research Site
Gyeonggi-do
South Korea
Research Site
Incheon
South Korea
Research Site
Seongnam-si
South Korea
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
Research Site
Badalona
Spain
+ 16 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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