Anticancer Treatment Clinical Trial
— AURA3Official title:
A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum-Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3).
| Verified date | September 2023 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene
| Status | Active, not recruiting |
| Enrollment | 419 |
| Est. completion date | December 29, 2023 |
| Est. primary completion date | April 15, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility | Inclusion Criteria: - Subjects with histologically or cytologically documented NSCLC. - Locally advanced or metastatic NSCLC - Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment - Eligible to receive treatment with the selected doublet-chemotherapy - Central confirmation of T790M+ mutation status - World Health Organization (WHO) performance status 0-1 - At least one lesion, not previously irradiated. Exclusion Criteria: - • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment - Treatment with more than one prior line of treatment for advanced NSCLC - Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment - Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment - Previous treatment with Osimertinib, or a 3rd generation EGFR TKI For subjects who cross-over to Osimertinib: - Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review. - At least 14 days since last dose of platinum-based doublet chemotherapy |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Darlinghurst | |
| Australia | Research Site | Heidelberg | |
| Australia | Research Site | Kogarah | |
| Australia | Research Site | Nedlands | |
| Australia | Research Site | Woolloongabba | |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Changchun | |
| China | Research Site | Chongqing | |
| China | Research Site | Chongqing | |
| China | Research Site | Fuzhou | |
| China | Research Site | Guangzhou | |
| China | Research Site | Guangzhou | |
| China | Research Site | Hangzhou | |
| China | Research Site | Harbin | |
| China | Research Site | Nanchang | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Tianjin | |
| China | Research Site | Ürümqi | |
| China | Research Site | Zhengzhou | |
| France | Research Site | Clermont Ferrand | |
| France | Research Site | Dijon | |
| France | Research Site | Lille | |
| France | Research Site | Marseille Cedex 20 | |
| France | Research Site | Paris | |
| France | Research Site | Strasbourg Cedex | |
| France | Research Site | Toulouse Cedex 09 | |
| France | Research Site | Villejuif | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Gerlingen | |
| Germany | Research Site | Oldenburg | |
| Germany | Research Site | Regensburg | |
| Germany | Research Site | Würzburg | |
| Hong Kong | Research Site | Hong Kong | |
| Hong Kong | Research Site | Shatin | |
| Hungary | Research Site | Budapest | |
| Italy | Research Site | Avellino | |
| Italy | Research Site | Meldola | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Orbassano | |
| Italy | Research Site | Roma | |
| Japan | Research Site | Akashi-shi | |
| Japan | Research Site | Bunkyo-ku | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Hirakata-shi | |
| Japan | Research Site | Kanazawa | |
| Japan | Research Site | Kitaadachi-gun | |
| Japan | Research Site | Kobe-shi | |
| Japan | Research Site | Kurashiki-shi | |
| Japan | Research Site | Kyoto-shi | |
| Japan | Research Site | Matsuyama-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Natori-shi | |
| Japan | Research Site | Niigata-shi | |
| Japan | Research Site | Okayama-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Osakasayama | |
| Japan | Research Site | Sakai-shi | |
| Japan | Research Site | Shinjuku-ku | |
| Japan | Research Site | Sunto-gun | |
| Japan | Research Site | Takatsuki-shi | |
| Japan | Research Site | Wakayama-shi | |
| Japan | Research Site | Yokohama-shi | |
| Japan | Research Site | Yokohama-shi | |
| Japan | Research Site | Yokohama-shi | |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Cheongju-si | |
| Korea, Republic of | Research Site | Goyang-si | |
| Korea, Republic of | Research Site | Incheon | |
| Korea, Republic of | Research Site | Jinju-si | |
| Korea, Republic of | Research Site | Seongnam-si | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Suwon-si | |
| Korea, Republic of | Research Site | Ulsan | |
| Mexico | Research Site | Mexico | |
| Mexico | Research Site | Oaxaca | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Groningen | |
| Russian Federation | Research Site | Ekaterinburg | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Omsk | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint Petersburg, | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Málaga | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Zaragoza | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Stockholm | |
| Taiwan | Research Site | Changhua | |
| Taiwan | Research Site | Hsinchu | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Kaohsiung City | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taoyuan | |
| United Kingdom | Research Site | Aberdeen | |
| United Kingdom | Research Site | Bristol | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Huddersfield | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Newcastle-Upon-Tyne | |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Wolverhampton | |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Brick | New Jersey |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Chevy Chase | Maryland |
| United States | Research Site | Gainesville | Florida |
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Lacey | Washington |
| United States | Research Site | Lebanon | New Hampshire |
| United States | Research Site | Marrero | Louisiana |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | New York | New York |
| United States | Research Site | Norwalk | Connecticut |
| United States | Research Site | Orange | California |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Park Ridge | Illinois |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Santa Rosa | California |
| United States | Research Site | Tacoma | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Australia, Canada, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Russian Federation, Spain, Sweden, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Time to First Subsequent Therapy (TFST) | Time from randomisation to first subsequent anti-cancer therapy (FST) following randomised treatment discontinuation, or death if no FST administered. Any patient not known to have died nor received any subsequent anti-cancer therapy (ST) was censored at the last time known not to have received ST, ie, the last follow-up visit this was confirmed. | From date of randomisation until time of final OS analysis, a median follow-up of 43 months | |
| Other | Time to Second Subsequent Therapy (TSST) | Time from randomisation to second subsequent anti-cancer therapy (SST) following randomised treatment discontinuation, or death if no SST administered. Any patient not known to have died nor received any SST was censored at the last time known not to have received SST, ie, the last follow-up visit this was confirmed. | From date of randomisation until time of final OS analysis, a median follow-up of 43 months | |
| Primary | Progression Free Survival (PFS) by Investigator Assessment | Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment. | RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis). | |
| Secondary | Objective Response Rate (ORR) by Investigator Assessment | Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy. | RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis). | |
| Secondary | Duration of Response (DoR) by Investigator Assessment | Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. | RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis). | |
| Secondary | Disease Control Rate (DCR) by Investigator Assessment | Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD at >=6 weeks, prior to any progressive disease (PD). | RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis). | |
| Secondary | Tumour Shrinkage by Investigator Assessment | Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is percentage change in tumour size from baseline using RECIST v1.1 tumour response. | RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis). | |
| Secondary | Secondary: Overall Survival (OS) | From date of randomization until time of final OS analysis, a median follow-up of 43 months |