An open-label, single-arm, Phase II, multinational, multicentre study to assess the efficacy and safety of 5 years of osimertinib in participants with epidermal growth factor receptor mutation-positive Stage II-IIIB non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy (TARGET)

You likely can't join if

• Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study drug
• Participants currently receiving (or unable to stop use prior to receiving the first dose of study intervention) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to first dose) (Appendix G). All participants must try to avoid concomitant use of any medications, herbal supplements, and/or ingestion of food with known inducer effects on CYP3A4. Participants with any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy will not be eligible.
• Participants 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 before the start of study intervention and that, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol; or active infection (eg, participants receiving treatment for infection including, hepatitis C and human immunodeficiency virus, or active, uncontrolled HBV infection). - Screening for chronic conditions is not required. - Active infection will include any participants receiving treatment for infection. Should participants with HBV infection be included, they are only eligible if they meet all the following criteria: -Demonstrated absence of HCV co-infection or history of HCV co-infection -Demonstrated absence of HIV infection -Participants with active HBV infection are eligible if they are: Receiving anti-viral treatment for at least 6 weeks prior to study intervention, HBV DNA is suppressed to < 100 IU/mL and transaminase levels are below ULN. - Participants with a resolved or chronic HBV infection are eligible if they are: Negative for HBsAg and positive for hepatitis B core antibody (anti-HBc IgG or total anti-HBc Ab). In addition, participants must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study intervention. Positive for HBsAg, but for > 6 months have had transaminases levels below ULN and HBV DNA levels below < 100 IU/mL (ie, are in an inactive carrier state). In addition, participants must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study intervention. Refer to Section 5.3. Should participants with HIV infection be included, they are only eligible if they meet all the following criteria: − Demonstrated absence of HBV/HCV co-infection − Undetectable viral RNA load for 6 months − CD4+ count of > 350 cells/μL − No history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months − Stable for at least 4 weeks on the same anti-HIV medications
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib