BridgeMD
A trial to learn how well osimertinib (AZD9291) works to prevent cancer from coming back after surgery and how safe it is compared to the placebo in adults with non-small cell lung cancer with an EGFR mutation.
EU CTIS ID: 2023-506524-82-00
What this study is testing
To assess the efficacy of Osimertinib compared to placebo as measured by disease free survival (DFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female, aged at least 18 years.
- Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology.
- MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
- Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
- Confirmation by the central laboratory that the tumour 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 including T790M.
- 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.
You likely can't join if
- 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 anticancer therapy - Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time - Major surgery (including primary tumour surgery, excluding placement of vascular access within 4 weeks of the first dose of study drug - Patients currently receiving medications or herbal supplements known to be potent inducers of CYP3A4 - Treatment with an investigational drug within five half-lives of the compound or any of its related material.
- Patients who have had only segmentectomies or wedge resections.
- History of other malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- 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.
See the full eligibility criteria
Who can join
- Male or female, aged at least 18 years.
- Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology.
- MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
- Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
- Confirmation by the central laboratory that the tumour 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 including T790M.
- 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.
- Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
- World Health Organization Performance Status of 0 to 1.
- Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential.
What rules you out
- 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 anticancer therapy - Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time - Major surgery (including primary tumour surgery, excluding placement of vascular access within 4 weeks of the first dose of study drug - Patients currently receiving medications or herbal supplements known to be potent inducers of CYP3A4 - Treatment with an investigational drug within five half-lives of the compound or any of its related material.
- Patients who have had only segmentectomies or wedge resections.
- History of other malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- 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.
- Any of the following cardiac criteria: - Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value. - 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, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- Inadequate bone marrow reserve or organ-function.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Korea, Republic of
- Hong Kong
- United States
- Israel
- Taiwan
- Canada
- Australia
- Thailand
- Russian Federation
- Brazil
- China
- Japan
- Ukraine
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Korea, Republic of; Hong Kong; United States; Israel; Taiwan and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.