ADAURA 2

Male or female patient, aged 18 years or above (20 in Japan).

Histologically Stage IA2-IA3 NSCLC (both squamous and non-squamous histology).

EGFR-TKI sensitizing mutation (Ex19del, L858R), either alone or in combination with other EGFR mutations, as assessed by a tissue-based FDA-approved CDx for TAGRISSO.

Complete resection achieved (R0) after lobectomy, bilobectomy, segmentectomy or sleeve resection.

WHO PS is 0 or 1.

Life expectancy > 12 weeks at randomization. 

Mixed small cell and non-small cell histology.

Prior treatment (neoadjuvant or adjuvant) with anticancer therapy (including chemotherapy, radiotherapy, TKIs), or currently eligible for other locally approved anticancer treatment.

R1/R2 resection; pneumonectomy or wedge resection.

History of other malignancies (except those without substantial risk of recurrence).

History of or evidence of clinically active interstitial lung disease.

Cardiac criteria (Mean resting QTc > 470 msec, family history, clinically significant abnormalities).

Severe or uncontrolled systemic disease, which in the Investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.

Unable to stop specific concomitant medications known to be strong inducers of CYP3A4, or medications with known risk of prolonging QT interval or causing TdP.

Inadequate bone marrow reserve or organ function. 

Research Nurse: Emma Davies  (01253 951679) Emma.davies16@nhs.net

Administrator: Arun Prakash