A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

Trial Title: A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

NCT ID: NCT05526755

Condition: Stage II-IIIB Non-small Cell Lung Carcinoma

Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Osimertinib

Conditions: Keywords:
Stage II-IIIB Non-small Cell Lung Cancer
Adjuvant osimertinib
Adjuvant chemotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Osimertinib 80 mg/40 mg
Description: Participants will receive osimertinib (80 mg or 40 mg orally, once daily).
Arm group label: Osimertinib

Other name: AZD9291

Other name: TAGRISSO™

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.

Detailed description: This is a phase 2 open-label study to assess the efficacy and safety of osimertinib in participants with stage II-IIIB NSCLC with sensitising EGFR mutations. The study is designed to evaluate 5 years of adjuvant osimertinib therapy.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 130 Years

Healthy volunteers: No

Locations:

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City: Santa Rosa
Zip: 95403
Country: United States

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City: Las Vegas
Zip: 89169
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City: White Plains
Zip: 10601
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City: Hong Kong
Zip: 150001
Country: Hong Kong

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City: Hong Kong
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Address:
City: Avellino
Zip: 83100
Country: Italy

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City: Brescia
Zip: 25123
Country: Italy

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City: Lecce
Zip: 73100
Country: Italy

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City: Milano
Zip: 20141
Country: Italy

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City: Napoli
Zip: 80131
Country: Italy

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City: Palermo
Zip: 90146
Country: Italy

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City: Peschiera Del Garda
Zip: 37019
Country: Italy

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City: Reggio Emilia
Zip: 42123
Country: Italy

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City: Sondrio
Zip: 23100
Country: Italy

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City: Terni
Zip: 05100
Country: Italy

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Address:
City: Udine
Zip: 33100
Country: Italy

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Address:
City: Busan
Zip: 48108
Country: Korea, Republic of

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Name: Research Site

Address:
City: Busan
Zip: 49241
Country: Korea, Republic of

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Name: Research Site

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

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Name: Research Site

Address:
City: Daejeon
Zip: 35015
Country: Korea, Republic of

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Name: Research Site

Address:
City: Goyang-si
Zip: 410-769
Country: Korea, Republic of

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Name: Research Site

Address:
City: Gyeonggi-do
Zip: 13620
Country: Korea, Republic of

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City: Incheon
Zip: 21565
Country: Korea, Republic of

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City: Seongnam-si
Zip: 13496
Country: Korea, Republic of

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City: Seoul
Zip: 03080
Country: Korea, Republic of

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Name: Research Site

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

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Name: Research Site

Address:
City: Seoul
Zip: 05030
Country: Korea, Republic of

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Name: Research Site

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

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Name: Research Site

Address:
City: Seoul
Zip: 06273
Country: Korea, Republic of

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Name: Research Site

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

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Name: Research Site

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

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Address:
City: Kuala Lumpur
Zip: 59100
Country: Malaysia

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Name: Research Site

Address:
City: Kuantan
Zip: 25100
Country: Malaysia

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Name: Research Site

Address:
City: Kuching
Zip: 93586
Country: Malaysia

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Address:
City: Cebu
Zip: 6000
Country: Philippines

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Name: Research Site

Address:
City: Manila
Zip: 1000
Country: Philippines

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Name: Research Site

Address:
City: Quezon City
Zip: 1100
Country: Philippines

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Name: Research Site

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City: Singapore
Zip: 119074
Country: Singapore

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Name: Research Site

Address:
City: Badalona
Zip: 08013
Country: Spain

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Address:
City: Barcelona
Zip: 08036
Country: Spain

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Name: Research Site

Address:
City: Bilbao
Zip: 48013
Country: Spain

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Name: Research Site

Address:
City: Granada
Zip: 18014
Country: Spain

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Name: Research Site

Address:
City: L'Hospitalet de Llobregat
Zip: 08907
Country: Spain

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Name: Research Site

Address:
City: Madrid
Zip: 28007
Country: Spain

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Name: Research Site

Address:
City: Sevilla
Zip: 41009
Country: Spain

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City: Valencia
Zip: 46026
Country: Spain

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Address:
City: Hualien
Zip: 970
Country: Taiwan

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Name: Research Site

Address:
City: Kaohsiung City
Zip: 833401
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Kaohsiung
Zip: 82445
Country: Taiwan

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Name: Research Site

Address:
City: Taichung
Zip: 40705
Country: Taiwan

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Name: Research Site

Address:
City: Taipei
Zip: 10449
Country: Taiwan

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Name: Research Site

Address:
City: Bangkok
Zip: 10700
Country: Thailand

Facility:
Name: Research Site

Address:
City: Songkhla
Zip: 90110
Country: Thailand

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Name: Research Site

Address:
City: London
Zip: SW3 6JJ
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: Nottingham
Zip: NG5 1PB
Country: United Kingdom

Start date: March 6, 2023

Completion date: April 5, 2029

Lead sponsor:
Agency: AstraZeneca
Agency class: Industry

Source: AstraZeneca

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05526755