CAURAL AZD9291+MEDI4736 in Combination for NSCLC in 2nd Line or higher
Research type
Research Study
Full title
A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of AZD9291 in Combination with MEDI4736 versusAZD9291 Monotherapy in Patients with Locally Advanced or Metastatic Epidermal Growth Factor Receptor T790M mutation-positive Non-Small Cell Lung Cancer who have received Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy (CAURAL)
IRAS ID
183351
Contact name
Raffaele Califano
Contact email
Sponsor organisation
AstraZeneca UK Ltd
Eudract number
2015-001858-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 27 days
Research summary
This a phase III, Multi Centre, Open Label, Randomized, Study to Assess the Efficacy and Safety of AZD9291 (80 mg, orally, once daily) in Combination with MEDI4736 (10 mg/kg (IV) infusion q2w (every 2 weeks)) versus AZD9291 Monotherapy (80 mg, orally, once daily) in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) T790M mutation positive non small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR-tyrosine kinase inhibitor (EGFR-TKI) agent.
The randomization will be stratified by previous lines of treatment (2nd or 3rd+) and ethnicity (Asian or Non-Asian). A mandatory biopsy will be needed for central testing of the T790M mutation status following confirmed disease progression on the most recent treatment regimen.
The primary objective of the study is to assess the efficacy of AZD9291 in combination with MEDI4736 versus AZD9291 monotherapy by assessment of progression free survival (PFS) by investigators according to RECIST 1.1.
Approximately 350 patients will be evaluated and will consist of 2 populations:
1. 2nd line: patients who have progressed following an approved first-line EGFR-TKI treatment but who have not received further treatment.
2. 3rd line or higher: patients who have progressed following prior therapy with an approved EGFR-TKI and an additional anti-cancer treatment. Patients may have also received additional lines of treatment.There is no maximum duration of treatment as patients should continue on their randomized treatment until a treatment discontinuation criterion is met or until confirmed disease progression according to RECIST 1.1 modified for confirmation of progression. They may also receive treatment beyond progression if the treatment shows clinical benefit, as judged by the Investigator. Following disease progression and treatment discontinuation, patients will be followed for survival.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0628
Date of REC Opinion
27 Aug 2015
REC opinion
Favourable Opinion