AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
AZD9291 80 mg/40 mg: The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Placebo AZD9291 80 mg/40 mg: The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Open-label AZD9291 80 mg/40 mg: Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.
Study summary
To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, 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 non small lung cancer (NSCLC) on predominantly non-squamous histology
3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
4. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
5. 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.
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 the time of randomization.
8. World Health Organization Performance Status of 0 to 1.
9. 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.
Exclusion Criteria:
1. 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 cytochrome P450 (CYP) 3A4
* Treatment with an investigational drug within five half-lives of the compound or any of its related material.
2. Patients who have had only segmentectomies or wedge resections
3. 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 following the end of treatment.
4. 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.
5. 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).
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 AZD9291.
7. 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.
8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
9. Inadequate bone marrow reserve or organ function.
Primary outcome measure(s)
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS). — Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months) Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Trial sites (238)
Facility
City
Region
Status
Research Site
Los Angeles
California
Research Site
Santa Monica
California
Research Site
Santa Rosa
California
Research Site
Torrance
California
Research Site
Grand Junction
Colorado
Research Site
New Haven
Connecticut
Research Site
Norwalk
Connecticut
Research Site
Fort Myers
Florida
Research Site
Pembroke Pines
Florida
Research Site
St. Petersburg
Florida
Research Site
Athens
Georgia
Research Site
Honolulu
Hawaii
Research Site
Chicago
Illinois
Research Site
Elk Grove Village
Illinois
Research Site
Bethesda
Maryland
Research Site
Brick
New Jersey
Research Site
Florham Park
New Jersey
Research Site
Mineola
New York
Research Site
Pawtucket
Rhode Island
Research Site
Chattanooga
Tennessee
Research Site
Nashville
Tennessee
Research Site
San Antonio
Texas
Research Site
Fort Belvoir
Virginia
Research Site
Bedford Park
Australia
Research Site
Camperdown
Australia
Research Site
Darlinghurst
Australia
Research Site
Heidelberg
Australia
Research Site
Kogarah
Australia
Research Site
Kurralta Park
Australia
Research Site
Woolloongabba
Australia
Research Site
Brussels
Belgium
Research Site
Brussels
Belgium
Research Site
Ghent
Belgium
Research Site
Kortrijk
Belgium
Research Site
Barretos
Brazil
Research Site
Cachoeira de Itapemirim
Brazil
Research Site
Curitiba
Brazil
Research Site
Florianópolis
Brazil
Research Site
Fortaleza
Brazil
Research Site
Lajeado
Brazil
+ 198 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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