AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Co… (NCT02511106) | Clinical Trial Compass
Active — Not RecruitingPhase 3
AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
United States682 participantsStarted 2015-10-21
Plain-language 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
Who can participate
Age range18 Years – 130 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Treatment with any of the following:
✕. Patients who have had only segmentectomies or wedge resections
✕. 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.
What they're measuring
1
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Timeframe: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
✕. 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 AZD9291.
✕. Any of the following cardiac criteria:
✕. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.