Lung Cancer Clinical Trial
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)
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.
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.
Spinal cord compression; and unstable brain metastases, with stable brain metastases who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids can be enrolled. Patients with asymptomatic brain metastases can be eligible for inclusion if in the opinion of the Investigator immediate definitive treatment is not indicated
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 (
Hemoglobin <90 gL. 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 mLmin 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.
Radiotherapy treatment to more than 30% of the bone marrow or( with a wide field of radiation within 4 weeks of the first dose of investigational product (IP).
History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP).
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There are 151 Locations for this study
Bellflower California, 90706, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Santa Monica California, 90404, United States
Santa Rosa California, 95403, United States
West Hollywood California, 90048, United States
Whittier California, 90602, United States
Orlando Florida, 32804, United States
Tampa Florida, 33612, United States
Kansas City Kansas, 66160, United States
Louisville Kentucky, 40202, United States
Boston Massachusetts, 02215, United States
Henderson Nevada, 89074, United States
Albany New York, 12208, United States
Canton Ohio, 44710, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77090, United States
San Antonio Texas, 78240, United States
Blacksburg Virginia, 24060, United States
Fairfax Virginia, 22031, United States
Vancouver Washington, 98684, United States
Buenos Aires , C1056, Argentina
Caba , C1012, Argentina
Caba , C1019, Argentina
Ciudad Autonoma De Buenos Aire , C1125, Argentina
Ciudad de Buenos Aires , 1280, Argentina
Cordoba , 5001, Argentina
Santa Fe , 2000, Argentina
Camperdown , 2050, Australia
Chermside , 4032, Australia
Elizabeth Vale , 5112, Australia
Heidelberg , 3084, Australia
Kogarah , 2217, Australia
Melbourne , 3000, Australia
Barretos , 14784, Brazil
Florianópolis , 88034, Brazil
Londrina , 86015, Brazil
Porto Alegre , 91350, Brazil
Ribeirão Preto , 14021, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 04029, Brazil
São José do Rio Preto , 15090, Brazil
Vitoria , 29043, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 2, Canada
Santiago , 75007, Chile
Santiago , 84203, Chile
Temuco , 48104, Chile
Viña del Mar , 25404, Chile
Beijing , 10014, China
Beijing , 10019, China
Beijing , , China
Changchun , 13000, China
Changsha , 41001, China
Chengdu , 61004, China
Chongqing , 40003, China
Guangzhou , 51051, China
Haikou , 57031, China
Hangzhou , 31000, China
Hangzhou , 31002, China
Harbin , 15008, China
Hefei , 23000, China
Jinan , 25000, China
Nanjing , 21000, China
Shanghai , 20003, China
Shanghai , 20003, China
Shenyang , 11000, China
Urumqi , 83000, China
Wuhan , 43003, China
Xi'an , 71006, China
Zhengzhou , 45000, China
Olomouc , 775 2, Czechia
Ostrava - Vitkovice , 703 8, Czechia
Praha 5 , 150 0, Czechia
Praha , 140 5, Czechia
Bordeaux Cedex , 33075, France
Lyon , 69373, France
Montpellier , 34298, France
Villejuif Cedex , 94805, France
Bangalore , 56006, India
Belagavi , 59001, India
Gurgaon , 12200, India
Kolkata , 70016, India
New Delhi , 110 0, India
Pune , 41100, India
Bunkyo-ku , 113-8, Japan
Bunkyo-ku , 113-8, Japan
Fukuoka , 812-8, Japan
Hidaka-shi , 350-1, Japan
Himeji-shi , 670-8, Japan
Iwakuni-shi , 740-8, Japan
Kanazawa , 920-8, Japan
Kashiwa , 227-8, Japan
Koto-ku , 135-8, Japan
Osaka-shi , 541-8, Japan
Sakai-shi , 591-8, Japan
Sapporo-shi , 003-0, Japan
Sendai-shi , 980-0, Japan
Sunto-gun , 411-8, Japan
Yokohama-shi , 241-8, Japan
Cheongju-si , 28644, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Arequipa , AREQU, Peru
Lima , L27, Peru
Lima , Lima , Peru
Lima , LIMA , Peru
San Isidro , 27, Peru
Cebu City , 6000, Philippines
Davao City , 8000, Philippines
Iloilo City , 5000, Philippines
Las Pinas , 1740, Philippines
Legazpi City , 4500, Philippines
Quezon City , 1100, Philippines
Quezon City , 1112, Philippines
Moscow , 11547, Russian Federation
Moscow , 14342, Russian Federation
Murmansk , 18304, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint Petersburg , 19825, Russian Federation
Saint-Petersburg , 19435, Russian Federation
Syktyvkar , 16790, Russian Federation
Banska Bystrica , 97517, Slovakia
Bratislava , 82606, Slovakia
Kosice , 041 9, Slovakia
Poprad , 05801, Slovakia
Johannesburg , 2196, South Africa
Port Elizabeth , 6045, South Africa
Rondebosch , 7700, South Africa
Changhua , 500, Taiwan
Hualien City , 97002, Taiwan
Kaohsiung City , 80756, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Taipei , 10002, Taiwan
Taipei , 23561, Taiwan
Bangkok , 10210, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Hat Yai , 90110, Thailand
Khon Kaen , 40002, Thailand
Muang , 50200, Thailand
Cambridge , CB2 0, United Kingdom
Leicester , LE1 5, United Kingdom
Liverpool , L7 8Y, United Kingdom
Maidstone , ME16 , United Kingdom
Manchester , M20 4, United Kingdom
Hanoi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
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