AZD9291
ASTRAZENECA PLC AZN · Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer; Stage IB-IIIA Non-small Cell Lung Carcinoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer; Stage IB-IIIA Non-small Cell Lung Carcinoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 3 Dec 20142 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for AZD9291. Editors add each one with its source.
Filed application
No filed application is on record for AZD9291. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for AZD9291.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT02511106ClinicalTrials.gov record for NCT02511106 (opens in a new tab)ADAURA | AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy. | Phase 3 | Active, not recruiting | 682 (actual) | 11 Apr 2022 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02511106 (opens in a new tab) |
Posted results on ClinicalTrials.gov for ADAURA
Serious adverse events (Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.): AZD9291 68 of 337; Placebo 47 of 343 Source: ClinicalTrials.gov results for NCT02511106 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing ADAURA (14), newest first
All 14 publications for NCT02511106 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02296125ClinicalTrials.gov record for NCT02296125 (opens in a new tab)FLAURA | AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer | Phase 3 | Completed | 674 (actual) | 19 Jun 2017 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02296125 (opens in a new tab) |
Posted results on ClinicalTrials.gov for FLAURA
Serious adverse events (All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued): Osimertinib 80 mg (Global Cohort) 74 of 279; SoC EGFR-TKI (Global Cohort) 76 of 277; Osimertinib 80 mg (China Cohort) 25 of 71; SoC EGFR-TKI (China Cohort) 12 of 65 Source: ClinicalTrials.gov results for NCT02296125 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing FLAURA (15), newest first
All 15 publications for NCT02296125 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as AZD9291.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT02511106 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT02296125 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.