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Clinical Trials in the USA / NCT02511106
Active, not recruiting Phase 3

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

NCT02511106 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2015-10-21
Last updated
2026-09-11

Condition(s) studied

Stage IB-IIIA Non-small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

AZD9291 80 mg/40 mgPlacebo AZD9291 80 mg/40 mgOpen-label AZD9291 80 mg/40 mg

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)

Trial sites (238)

FacilityCityRegionStatus
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.

More AstraZeneca trials in the USA

Official registry record

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.

View NCT02511106 on ClinicalTrials.gov ↗ ← All trials in the USA