A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)
FLAURA2
A Phase III, Open-label, Randomized Study of Osimertinib With or Without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).
2 other identifiers
interventional
587
21 countries
153
Brief Summary
The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR). Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer. The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Jul 2019
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
153 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2019
CompletedStudy Start
First participant enrolled
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2023
CompletedResults Posted
Study results publicly available
August 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2026
ExpectedOctober 10, 2025
September 1, 2025
3.8 years
June 27, 2019
February 20, 2024
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only)
Adverse events were summarized by maximum reported Common Terminology Criteria for Adverse Event (CTCAE) grade, version 5.0. Grade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 (Severe or medically significant but not immediately life-threatening): hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 (Life-threatening consequences): urgent intervention indicated. Grade 5: Death related to AE. Includes adverse events with onset date on or after the date of first dose and up to and including 28 days following discontinuation of treatment but prior to the start of a new anti-cancer therapy.
From first dose date to 28 days following last dose, up to 45 months
Progression-free Survival (PFS) (Randomized Component)
Progression-free survival (PFS) using Investigator assessment as defined by RECIST 1.1. Median progression free survival (months) calculated using the Kaplan-Meier method. Progression-free survival (PFS) is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment. The primary efficacy analysis of the investigator-assessed progression-free survival will be performed when approximately 278 PFS events and at least 16 months of follow-up after Last subject in, has occurred in the 556 randomized patients.
Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.3 months)
Sensitivity Analysis for Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment (Randomized Component)
Sensitivity analysis for progression-free survival (PFS) by blinded independent central review (BICR) using Investigator assessment as defined by RECIST 1.1. Median progression free survival (months) calculated using the Kaplan-Meier method. Progression-free survival (PFS) is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment. The primary efficacy analysis of the investigator-assessed progression-free survival will be performed when approximately 278 PFS events and at least 16 months of follow-up after Last subject in, has occurred in the 556 randomized patients.
Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.2 months).
Secondary Outcomes (29)
Overall Survival (OS) (Safety Run-In Treatment Arms Only)
Up to 45 months (maximum follow up 44.6 months)
Duration of Response (DoR) (Safety Run-In Treatment Arms Only)
Up to 45 months
Objective Response Rate (ORR) (Safety Run-In Treatment Arms Only)
Up to 45 months
Depth of Response (Percent Change From Baseline in Tumor Diameter) (Safety Run-In Treatment Arms Only)
Up to 45 months
Disease Control Rate (DCR) by Investigator (Safety Run-In Treatment Arms Only)
Up to 45 months
- +24 more secondary outcomes
Study Arms (2)
Osimertinib 80mg QD
ACTIVE COMPARATOROsimertinib (AZD9291) 80mg QD. All patients randomized into this will only receive Osimertinib 80mg. Dose may be reduced to allow for the management of IP related toxicity.
Osimertinib 80 mg QD and platinum-based chemotherapy
EXPERIMENTALOsimertinib 80 mg in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks. Dose may be reduced to allow for the management of IP related toxicity.
Interventions
Drug: Osimertinib (Oral) Other Names: AZD9291
Drug: Pemetrexed (500 mg/m2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
Drug: Pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
Eligibility Criteria
You may qualify if:
- Male or female, at least 18 years of age; patients from Japan at least 20 years of age.
- Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC). NSCLC of mixed histology is allowed.
- Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M.
- Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- WHO PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks.
- Life expectancy \>12 weeks at Day 1.
- Willing to use contraception as appropriate during the study and for a period of time after discontinuing study treatment.
You may not qualify if:
- Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease.
- 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 patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including Hep. B, Hep. C and HIV. Screening for chronic conditions is not required. Active infection will include any patients receiving treatment for infection.
- QT prolongation or any clinically important abnormalities in rhythm.
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Absolute neutrophil count below the lower limit of normal (\<LLN)
- Platelet count below the LLN
- Hemoglobin \<90 g/L. The use of granulocyte colony stimulating factor support, platelet transfusion and blood transfusions to meet these criteria is not permitted.
- ALT \>2.5 x the upper limit of normal (ULN) if no demonstrable liver metastases or \>5 x ULN in the presence of liver metastases
- AST \>2.5 x ULN if no demonstrable liver metastases or \>5 x ULN in the presence of liver metastases
- Total bilirubin \>1.5 x ULN if no liver metastases or \>3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
- Creatinine clearance \<60 mL/min calculated by Cockcroft and Gault equation or 24 hour urine collection (refer to Appendix I for appropriate calculation)
- 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.
- Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiation including chemotherapy, biologic therapy, immunotherapy, or any investigational drug. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.
- Prior treatment with an Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI).
- Major surgery within 4 weeks of the first dose of investigational product (IP). Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy via video assisted thoracoscopic surgery are permitted.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (153)
Research Site
Bellflower, California, 90706, United States
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Fullerton, California, 92835, United States
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La Jolla, California, 92093, United States
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Santa Monica, California, 90404, United States
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Santa Rosa, California, 95403, United States
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West Hollywood, California, 90048, United States
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Whittier, California, 90602, United States
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Orlando, Florida, 32804, United States
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Tampa, Florida, 33612, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40202, United States
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Boston, Massachusetts, 02215, United States
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Henderson, Nevada, 89074, United States
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Albany, New York, 12208, United States
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Canton, Ohio, 44710, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Houston, Texas, 77090, United States
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San Antonio, Texas, 78240, United States
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Blacksburg, Virginia, 24060, United States
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Fairfax, Virginia, 22031, United States
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Vancouver, Washington, 98684, United States
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Buenos Aires, C1056ABJ, Argentina
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Buenos Aires, C1125ABD, Argentina
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CABA, C1012AAR, Argentina
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CABA, C1019ABS, Argentina
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Ciudad de Buenos Aires, 1280, Argentina
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Córdoba, 5001, Argentina
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Santa Fe, 2000, Argentina
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Camperdown, 2050, Australia
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Chermside, 4032, Australia
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Elizabeth Vale, 5112, Australia
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Heidelberg, 3084, Australia
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Kogarah, 2217, Australia
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Melbourne, 3000, Australia
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Barretos, 14784-400, Brazil
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Florianópolis, 88034-000, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 91350-200, Brazil
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Ribeirão Preto, 14021-636, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 04029-000, Brazil
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Vitória, 29043-260, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Santiago, 7500713, Chile
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Santiago, 8420383, Chile
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Temuco, 4810469, Chile
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Viña del Mar, 2540488, Chile
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Beijing, 100142, China
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Beijing, 100191, China
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Beijing, 100853, China
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Changchun, 130000, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Guangzhou, 510515, China
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Haikou, 570312, China
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Hangzhou, 310003, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Jinan, 250001, China
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Nanjing, 210009, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shenyang, 110001, China
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Ürümqi, 830000, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Olomouc, 775 21, Czechia
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Ostrava - Vitkovice, 703 84, Czechia
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Prague, 140 59, Czechia
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Prague, 150 06, Czechia
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Bordeaux, 33075, France
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Lyon, 69373, France
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Montpellier, 34298, France
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Villejuif, 94805, France
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Belagavi, 590010, India
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Bengaluru, 560027, India
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Gūrgaon, 122001, India
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Kolkata, 700160, India
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New Delhi, 110 085, India
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Pune, 411004, India
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8603, Japan
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Fukuoka, 812-8582, Japan
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Hidaka-shi, 350-1298, Japan
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Himeji-shi, 670-8520, Japan
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Iwakuni-shi, 740-8510, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 227-8577, Japan
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Kōtoku, 135-8550, Japan
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Osaka, 541-8567, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 003-0804, Japan
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Sendai, 981-0914, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 241-8515, Japan
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Arequipa, AREQUIPA01, Peru
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Lima, 15036, Peru
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Lima, Lima 32, Peru
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Lima, LIMA 34, Peru
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San Isidro, 27, Peru
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Cebu City, 6000, Philippines
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Davao City, 8000, Philippines
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Iloilo City, 5000, Philippines
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Las Piñas, 1740, Philippines
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Legaspi, 4500, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1112, Philippines
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Moscow, 115478, Russia
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Moscow, 143423, Russia
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Murmansk, 183047, Russia
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Saint Petersburg, 194356, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 198255, Russia
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Syktyvkar, 167904, Russia
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Bratislava, 82606, Slovakia
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Košice, 041 91, Slovakia
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Poprad, 05801, Slovakia
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Johannesburg, 2196, South Africa
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Port Elizabeth, 6045, South Africa
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Rondebosch, 7700, South Africa
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Cheongju-si, 28644, South Korea
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Changhua, 500, Taiwan
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Hualien City, 97002, Taiwan
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Kaohsiung City, 00807, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 23561, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 50200, Thailand
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Cambridge, CB2 0QQ, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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Liverpool, L7 8YA, United Kingdom
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Maidstone, ME16 9QQ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
Related Publications (7)
Janne PA, Planchard D, Kobayashi K, Yang JC, Liu Y, Valdiviezo N, Kim TM, Jiang L, Kagamu H, Yanagitani N, Wang J, Biswas B, Poltoratskiy A, Neron Y, Rojas C, Koubkova L, Escriu C, Ezeife DA, Mann H, Armenteros-Monterroso E, Rukazenkov Y, Lee CK; FLAURA2 Investigators. Survival with Osimertinib plus Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2026 Jan 1;394(1):27-38. doi: 10.1056/NEJMoa2510308. Epub 2025 Oct 17.
PMID: 41104938DERIVEDMurat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.
PMID: 40311309DERIVEDJanne PA, Planchard D, Kobayashi K, Cheng Y, Lee CK, Valdiviezo N, Laktionov K, Yang TY, Yu Y, Kato T, Jiang L, Chewaskulyong B, Lucien Geater S, Maurel JM, Rojas C, Takahashi T, Havel L, Shepherd FA, Tanaka K, Ghiorghiu D, Amin NP, Armenteros-Monterroso E, Huang X, Chaudhry AA, Yang JC. CNS Efficacy of Osimertinib With or Without Chemotherapy in Epidermal Growth Factor Receptor-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2024 Mar 1;42(7):808-820. doi: 10.1200/JCO.23.02219. Epub 2023 Dec 2.
PMID: 38042525DERIVEDPlanchard D, Janne PA, Cheng Y, Yang JC, Yanagitani N, Kim SW, Sugawara S, Yu Y, Fan Y, Geater SL, Laktionov K, Lee CK, Valdiviezo N, Ahmed S, Maurel JM, Andrasina I, Goldman J, Ghiorghiu D, Rukazenkov Y, Todd A, Kobayashi K; FLAURA2 Investigators. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2023 Nov 23;389(21):1935-1948. doi: 10.1056/NEJMoa2306434. Epub 2023 Nov 8.
PMID: 37937763DERIVEDPlanchard D, Feng PH, Karaseva N, Kim SW, Kim TM, Lee CK, Poltoratskiy A, Yanagitani N, Marshall R, Huang X, Howarth P, Janne PA, Kobayashi K. Osimertinib plus platinum-pemetrexed in newly diagnosed epidermal growth factor receptor mutation-positive advanced/metastatic non-small-cell lung cancer: safety run-in results from the FLAURA2 study. ESMO Open. 2021 Oct;6(5):100271. doi: 10.1016/j.esmoop.2021.100271. Epub 2021 Sep 17.
PMID: 34543864DERIVEDWhite MN, Piotrowska Z, Stirling K, Liu SV, Banwait MK, Cunanan K, Sequist LV, Wakelee HA, Hausrath D, Neal JW. Combining Osimertinib With Chemotherapy in EGFR-Mutant NSCLC at Progression. Clin Lung Cancer. 2021 May;22(3):201-209. doi: 10.1016/j.cllc.2021.01.010. Epub 2021 Jan 27.
PMID: 33610453DERIVEDAsahina H, Tanaka K, Morita S, Maemondo M, Seike M, Okamoto I, Oizumi S, Kagamu H, Takahashi K, Kikuchi T, Isobe T, Sugio K, Kobayashi K. A Phase II Study of Osimertinib Combined With Platinum Plus Pemetrexed in Patients With EGFR-Mutated Advanced Non-Small-cell Lung Cancer: The OPAL Study (NEJ032C/LOGIK1801). Clin Lung Cancer. 2021 Mar;22(2):147-151. doi: 10.1016/j.cllc.2020.09.023. Epub 2020 Oct 16.
PMID: 33199228DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Pasi A. Jänne, MD
Dana Farber Cancer Institute, 450 Brookline Avenue, LC4114, Boston, MA 02215, USA
- PRINCIPAL INVESTIGATOR
Kunihiko Kobayashi, MD
Department of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama, Japan
- PRINCIPAL INVESTIGATOR
David Planchard, MD
Department of Medical Oncology - Institut Gustave Roussy (IGR) - Villejuif - France
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2019
First Posted
July 29, 2019
Study Start
July 2, 2019
Primary Completion
April 3, 2023
Study Completion (Estimated)
December 22, 2026
Last Updated
October 10, 2025
Results First Posted
August 6, 2024
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.