Study Summary
This trial is studying osimertinib vs platinum-based doublet chemotherapy to see if they are better in treating patients with non-small cell lung cancer whose disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy and whose tumors contain a T790M mutation.
- Chemotherapy
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
2 Treatment Groups
Platinum-based doublet chemotherapy
1 of 2
Osimertinib
1 of 2
Active Control
Experimental Treatment
419 Total Participants · 2 Treatment Groups
Primary Treatment: Chemotherapy · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 130 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Papadimitrakopoulou, V.A., T.S. Mok, J.-Y. Han, M.-J. Ahn, A. Delmonte, S.S. Ramalingam, S.W. Kim, et al.. 2020. “Osimertinib Versus Platinum–pemetrexed for Patients with EGFR T790M Advanced NSCLC and Progression on a Prior Egfr-tyrosine Kinase Inhibitor: AURA3 Overall Survival Analysis”. Annals of Oncology. Elsevier BV. doi:10.1016/j.annonc.2020.08.2100.
- Papadimitrakopoulou, Vassiliki A., Ji‐Youn Han, Myung‐Ju Ahn, Suresh S. Ramalingam, Angelo Delmonte, Te‐Chun Hsia, Janessa Laskin, et al.. 2019. “Epidermal Growth Factor Receptor Mutation Analysis in Tissue and Plasma from the AURA3 Trial: Osimertinib Versus Platinum‐pemetrexed for T790M Mutation‐positive Advanced Non–small Cell Lung Cancer”. Cancer. Wiley. doi:10.1002/cncr.32503.
- Wu, Yi-Long, Myung-Ju Ahn, Marina Chiara Garassino, Ji-Youn Han, Nobuyuki Katakami, Hye Ryun Kim, Rachel Hodge, et al.. 2018. “CNS Efficacy of Osimertinib in Patients with T790m-positive Advanced Non–small-cell Lung Cancer: Data from a Randomized Phase III Trial (AURA3)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2018.77.9363.
- Lee, Chee Khoon, Silvia Novello, Anna Rydén, Helen Mann, and Tony Mok. 2018. “Patient-reported Symptoms and Impact of Treatment with Osimertinib Versus Chemotherapy in Advanced Non–small-cell Lung Cancer: The AURA3 Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.77.2293.
- Akamatsu, Hiroaki, Nobuyuki Katakami, Isamu Okamoto, Terufumi Kato, Young Hak Kim, Fumio Imamura, Masaharu Shinkai, Rachel A. Hodge, Hirohiko Uchida, and Toyoaki Hida. 2018. “Osimertinib in Japanese Patients with egfr T790M Mutation-positive Advanced Non-small-cell Lung Cancer: AURA3 Trial”. Cancer Science. Wiley. doi:10.1111/cas.13623.
- Mok, Tony S., Yi-Long Wu, Myung-Ju Ahn, Marina C. Garassino, Hye R. Kim, Suresh S. Ramalingam, Frances A. Shepherd, et al.. 2017. “Osimertinib or Platinum–pemetrexed in egfr T790m–positive Lung Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1612674.
- Soria, Jean-Charles, Yi-Long Wu, Kazuhiko Nakagawa, Sang-We Kim, Jin-Ji Yang, Myung-Ju Ahn, Jie Wang, et al.. 2015. “Gefitinib Plus Chemotherapy Versus Placebo Plus Chemotherapy in Egfr-mutation-positive Non-small-cell Lung Cancer After Progression on First-line Gefitinib (IMPRESS): A Phase 3 Randomised Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00121-7.
- Soria, Jean-Charles, Yi-Long Wu, Kazuhiko Nakagawa, Sang-We Kim, Jin-Ji Yang, Myung-Ju Ahn, Jie Wang, et al.. 2015. “Gefitinib Plus Chemotherapy Versus Placebo Plus Chemotherapy in Egfr-mutation-positive Non-small-cell Lung Cancer After Progression on First-line Gefitinib (IMPRESS): A Phase 3 Randomised Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00121-7.
- Mok, Tony S., Yi-Long Wu, Myung-Ju Ahn, Marina C. Garassino, Hye R. Kim, Suresh S. Ramalingam, Frances A. Shepherd, et al.. 2017. “Osimertinib or Platinum–pemetrexed in egfr T790m–positive Lung Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1612674.
- Wu, Yi-Long, Myung-Ju Ahn, Marina Chiara Garassino, Ji-Youn Han, Nobuyuki Katakami, Hye Ryun Kim, Rachel Hodge, et al.. 2018. “CNS Efficacy of Osimertinib in Patients with T790m-positive Advanced Non–small-cell Lung Cancer: Data from a Randomized Phase III Trial (AURA3)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2018.77.9363.
- King-Kallimanis, Bellinda L, Vishal Bhatnagar, Erica G Horodniceanu, Ting-Yu Chen, and Paul G Kluetz. 2022. “Timing Is Everything: The Importance of Patient-reported Outcome Assessment Frequency When Characterizing Symptomatic Adverse Events”. Clinical Trials. SAGE Publications. doi:10.1177/17407745221093935.
- Singh, Jeshika, Siobhan Bourke, Matthew Dyer, Nancy Devlin, and Louise Longworth. 2022. “An Analysis of 5-level Version of EQ-5D Adjusting for Treatment Switching: The Case of Patients with Epidermal Growth Factor Receptor T790m-positive Nonsmall Cell Lung Cancer Treated with Osimertinib”. Value in Health. Elsevier BV. doi:10.1016/j.jval.2022.01.022.
- Lee CK, Novello S, Ryden A, Mann H, Mok T. Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial. J Clin Oncol. 2018 Jun 20;36(18):1853-1860. doi: 10.1200/JCO.2017.77.2293. Epub 2018 May 7.
- 2014. "AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02151981.
Frequently Asked Questions
Does the FDA endorse chemotherapy as an effective cancer treatment?
"Chemotherapy, while not without its risks, has received a score of 3 because of the available data supporting its efficacy and safety." - Anonymous Online Contributor
Are there certain ineligibilities which would preclude an individual from joining this research project?
"The requirements to participate in this study are that patients have a diagnosis of lung cancer and are between 18-130 years old. The goal is to enroll 419 patients in total." - Anonymous Online Contributor
Does this study have a wide reach in terms of the number of participating clinics?
"There are 27 total active sites for this trial, which are situated in cities like Houston, Gainesville and Charleston. If you enroll in the study, choosing a location nearest to you will help reduce travel-related burden." - Anonymous Online Contributor
What other treatments have been studied that use Chemotherapy?
"The first chemotherapy trials were conducted in 2002 at the Department of Radiation Oncology in the National Cancer Center. As of today, there have been a total of 267 active studies, with a large portion of these ongoing clinical trials taking place in Houston, Texas." - Anonymous Online Contributor
Are there any participants currently needed for this experiment?
"As of now, this trial has paused recruitment. The study was first posted on 8/4/2014 and was most recently updated on 10/26/2022. However, if you are looking for other studies, there are presently 1940 studies actively enrolling participants with lung cancer and 267 trials for Chemotherapy that are still recruiting patients." - Anonymous Online Contributor
For this particular research project, are volunteers of all ages being accepted?
"According to the enrollment requirements for this clinical trial, individuals must be aged 18 or older but not 130 years old or above." - Anonymous Online Contributor
Could you share how many people are taking part in this experiment?
"Unfortunately, this clinical trial is not recruiting patients at the moment. Though, it is worth noting that the study was most recently updated on October 26th, 2022. For those searching for other studies, there are 1940 clinical trials actively enrolling participants with lung cancer and 267 clinical trials for Chemotherapy actively enrolling participants." - Anonymous Online Contributor