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| Overall Recruitment Status: Enrollment complete |
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| Official Title |
| AstraZeneca ADAURA D5164C00001: A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, study 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 |
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| Region |
Sponsors |
| Hawaii |
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| Acronym |
NCT No. |
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NCT02511106 |
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| Study Type |
Phase |
| Clinical Trial |
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| Purpose |
| This study is being carried out to see if AZD9291 is effective in treating early stage lung cancer after a complete surgical removal of the tumor and if so, how it compares with a placebo (does not contain any active drug). This study will also measure levels of drug in the blood and see how well it is tolerated. |
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| Detailed Description |
| This is phase 3, double-blind, randomized, placebo-controlled study, to assess efficacy and safety of AZD9291 versus placebo in patients with completely resected stage IB-IIIA NSCLC, which has been centrally confirmed to have one of the two most common (Ex19del and L858R) EGFR-sensitising mutations, either alone or in combination with other EGFR mutations.
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- 1. Provision of informed consent prior to any study specific procedures, sampling, and analyses
2. Male or female, aged at least 18 years. Patients from Japan/Taiwan aged at least 20 years
3. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology
4. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care. Patients in whom this was not done prior to surgery may still be enrolled if appropriate imaging is performed prior to randomization, i.e. MRI or CT of brain.
5. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria. Staging will be according to the TNM staging system for lung cancer (7th edition)
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- 1. Previous randomization and treatment in the present study
2. 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 , including investigational therapy, for treatment of NSCLC other than standard platinum based doublet post-operative adjuvant chemotherapy
- Prior treatment with neoadjuvant or adjuvant EGFR-TKI
- Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug
- Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior).
- Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.
3. Patients who have had only segmentectomies or wedge resections
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