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)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 ( Platelet count below the LLN
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).

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

587

Study ID:

NCT04035486

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 151 Locations for this study

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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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Los Angeles California, 90095, 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 , C1056, Argentina
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Caba , C1012, Argentina
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Caba , C1019, Argentina
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Ciudad Autonoma De Buenos Aire , C1125, Argentina
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Ciudad de Buenos Aires , 1280, Argentina
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Cordoba , 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, Brazil
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Florianópolis , 88034, Brazil
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Londrina , 86015, Brazil
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Porto Alegre , 91350, Brazil
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Ribeirão Preto , 14021, Brazil
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Sao Paulo , 01246, Brazil
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Sao Paulo , 04029, Brazil
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São José do Rio Preto , 15090, Brazil
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Vitoria , 29043, Brazil
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Calgary Alberta, T2N 4, Canada
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Edmonton Alberta, T6G 1, Canada
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Toronto Ontario, M5G 2, Canada
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Santiago , 75007, Chile
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Santiago , 84203, Chile
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Temuco , 48104, Chile
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Viña del Mar , 25404, Chile
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Beijing , 10014, China
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Beijing , 10019, China
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Beijing , , China
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Changchun , 13000, China
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Changsha , 41001, China
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Chengdu , 61004, China
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Chongqing , 40003, China
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Guangzhou , 51051, China
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Haikou , 57031, China
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Hangzhou , 31000, China
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Hangzhou , 31002, China
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Harbin , 15008, China
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Hefei , 23000, China
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Jinan , 25000, China
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Nanjing , 21000, China
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Shanghai , 20003, China
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Shanghai , 20003, China
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Shenyang , 11000, China
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Urumqi , 83000, China
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Wuhan , 43003, China
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Xi'an , 71006, China
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Zhengzhou , 45000, China
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Olomouc , 775 2, Czechia
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Ostrava - Vitkovice , 703 8, Czechia
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Praha 5 , 150 0, Czechia
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Praha , 140 5, Czechia
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Bordeaux Cedex , 33075, France
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Lyon , 69373, France
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Montpellier , 34298, France
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Villejuif Cedex , 94805, France
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Bangalore , 56006, India
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Belagavi , 59001, India
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Gurgaon , 12200, India
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Kolkata , 70016, India
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New Delhi , 110 0, India
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Pune , 41100, India
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Bunkyo-ku , 113-8, Japan
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Bunkyo-ku , 113-8, Japan
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Fukuoka , 812-8, Japan
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Hidaka-shi , 350-1, Japan
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Himeji-shi , 670-8, Japan
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Iwakuni-shi , 740-8, Japan
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Kanazawa , 920-8, Japan
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Kashiwa , 227-8, Japan
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Koto-ku , 135-8, Japan
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Osaka-shi , 541-8, Japan
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Sakai-shi , 591-8, Japan
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Sapporo-shi , 003-0, Japan
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Sendai-shi , 980-0, Japan
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Sunto-gun , 411-8, Japan
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Yokohama-shi , 241-8, Japan
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Cheongju-si , 28644, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Arequipa , AREQU, Peru
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Lima , L27, Peru
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Lima , Lima , Peru
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Lima , LIMA , 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 Pinas , 1740, Philippines
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Legazpi City , 4500, Philippines
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Quezon City , 1100, Philippines
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Quezon City , 1112, Philippines
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Moscow , 11547, Russian Federation
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Moscow , 14342, Russian Federation
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Murmansk , 18304, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Saint Petersburg , 19825, Russian Federation
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Saint-Petersburg , 19435, Russian Federation
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Syktyvkar , 16790, Russian Federation
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Banska Bystrica , 97517, Slovakia
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Bratislava , 82606, Slovakia
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Kosice , 041 9, 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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Changhua , 500, Taiwan
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Hualien City , 97002, Taiwan
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Kaohsiung City , 80756, 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 0, United Kingdom
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Leicester , LE1 5, United Kingdom
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Liverpool , L7 8Y, United Kingdom
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Maidstone , ME16 , United Kingdom
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Manchester , M20 4, United Kingdom
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Hanoi , 10000, Vietnam
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Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

587

Study ID:

NCT04035486

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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