Lung Cancer Clinical Trial

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

Summary

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female, at least 18 years of age. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient his or her legally acceptable representative
Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).
Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).

Exclusion Criteria:

Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
History of another primary malignancy, except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease
Patients who have pre-operative radiotherapy treatment as part of their care plan
Mixed small cell and NSCLC histology
Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC
T4 tumours infiltrating the aorta, the oesophagus and/or the heart; and/or any bulky N2 disease
Patients who are candidates to undergo only segmentectomies or wedge resections
Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
Prior treatment with EGFR-TKI therapy
Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

328

Study ID:

NCT04351555

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 207 Locations for this study

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Birmingham Alabama, 35233, United States
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Duarte California, 91010, United States
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Irvine California, 92618, United States
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Los Angeles California, 90048, United States
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San Francisco California, 94143, 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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New Haven Connecticut, 06510, United States
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Washington District of Columbia, 20007, United States
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Miami Florida, 33136, United States
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Chicago Illinois, 60637, United States
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Boston Massachusetts, 02215, United States
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Ann Arbor Michigan, 48109, United States
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Lebanon New Hampshire, 03756, United States
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Commack New York, 11725, United States
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New York New York, 10032, United States
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Houston Texas, 77030, United States
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San Antonio Texas, 78229, United States
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Fairfax Virginia, 22031, United States
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Seattle Washington, 98104, United States
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Linz , 4020, Austria
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Vienna , , Austria
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Wien , 1210, Austria
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Barretos , 14784, Brazil
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Belo Horizonte , 30110, Brazil
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Bento Goncalves , 95700, Brazil
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Fortaleza , 60135, Brazil
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Ibirapuera , 04501, Brazil
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Jau , 17204, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90610, Brazil
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Recife , 52010, Brazil
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Ribeirão Preto , 14021, Brazil
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Rio de Janeiro , 22271, Brazil
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Santa Maria , 97015, Brazil
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Sao Paulo , 01321, Brazil
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Sao Paulo , 01327, Brazil
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São José do Rio Preto , 15090, Brazil
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São Paulo , 04038, Brazil
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Panagyurishte , 4500, Bulgaria
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Pleven , 5804, Bulgaria
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Plovdiv , 4004, Bulgaria
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Sofia , 1113, Bulgaria
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Sofia , 1407, Bulgaria
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Sofia , 1527, Bulgaria
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Sofia , 1618, Bulgaria
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H2X 0, Canada
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Montreal Quebec, H4A 3, Canada
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La Serena , 17204, Chile
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Las Condes , 75609, Chile
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Providencia , 75100, Chile
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Santiago , 75007, Chile
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Santiago , 75009, Chile
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Santiago , 75203, Chile
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Santiago , 83804, Chile
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Santiago , 84203, Chile
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Viña del Mar , 25404, Chile
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Beijing , 10002, China
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Beijing , 10002, China
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Beijing , 10014, China
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Beijing , 10019, China
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Beijing , CN-10, China
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Changsha , 41000, 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 , 51006, China
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Guangzhou , 51009, China
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Guangzhou , 51012, China
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Guangzhou , 51051, China
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Hangzhou , 31000, China
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Hangzhou , 31000, China
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Hangzhou , 31002, China
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Hefei , 23000, China
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Kunming , 65011, China
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Linhai , 31700, China
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Nanchang , 33000, China
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Nanjing , 21002, China
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Nantong , 22600, China
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Shandong , , China
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Shanghai , 20003, China
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Shanghai , 20003, China
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Shanghai , 20043, China
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Shenzhen , 51805, China
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Suzhou , 21500, China
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Urumqi , 83000, China
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Wanzhou , 40400, China
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Wenzhou , CN-32, China
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Xiamen , 36100, China
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Yangzhou , 22500, China
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Zhengzhou , 45000, China
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Angers , 49033, France
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Avignon Cedex , 84902, France
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Bordeaux , 33000, France
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Clermont Ferrand , 63011, France
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Lyon , 69373, France
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Toulon Cedex 9 , 83800, France
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Berlin , 12351, Germany
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Bielefeld , 33611, Germany
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Esslingen a.N. , 73730, Germany
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Freiburg , 79106, Germany
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Gauting , 82131, Germany
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Georgsmarienhuette , 49124, Germany
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Halle , 06120, Germany
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Hamburg , 21075, Germany
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Heidelberg , 69126, Germany
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Homburg , 66421, Germany
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Köln , 51109, Germany
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Oldenburg , 26121, Germany
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Würzburg , 97067, Germany
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Delhi , 11008, India
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Kolkata , 70016, India
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Manipal , 57610, India
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Mumbai , 40001, India
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Mumbai , 40003, India
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Namakkal , 63700, India
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New Delhi , 11002, India
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Varanasi , 221 0, India
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Haifa , 31096, Israel
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Jerusalem , 91120, Israel
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Kfar Saba , 95847, Israel
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Petah Tikva , 49100, Israel
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Ramat Gan , 52656, Israel
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Tel Aviv , 62748, Israel
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Bari , 70124, Italy
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Firenze , 50134, Italy
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Monza , 20900, Italy
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Orbassano , 10043, Italy
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Padova , 35128, Italy
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Roma , 00144, Italy
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Roma , 00168, Italy
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Rozzano , 20089, Italy
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Varese , 21100, Italy
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Akashi-shi , 673-8, Japan
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Bunkyo-ku , 113-8, Japan
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Chiba-shi , 260-8, Japan
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Hiroshima-shi , 734-8, Japan
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Kashiwa , 227-8, Japan
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Koto-ku , 135-8, Japan
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Kyoto-shi , 606-8, Japan
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Niigata-shi , 951-8, Japan
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Osaka-shi , 541-8, Japan
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Osakasayama-shi , 589-8, Japan
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Sakai-shi , 591-8, Japan
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Sendai-shi , 980-0, Japan
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Shinjuku-ku , 160-0, Japan
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Sunto-gun , 411-8, Japan
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Yokohama-shi , 241-8, Japan
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Daegu , 41404, Korea, Republic of
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Daegu , 41931, Korea, Republic of
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Hwasun-gun , 58128, Korea, Republic of
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Incheon , 21431, Korea, Republic of
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Seoul , 02447, Korea, Republic of
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Seoul , 05030, Korea, Republic of
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Seoul , 08308, Korea, Republic of
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Yangsan-si , 50612, Korea, Republic of
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Aguascalientes , 20230, Mexico
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D.F , 14050, Mexico
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Mexico City , '1408, Mexico
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Mexico City , 06720, Mexico
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La Libertad , 13013, Peru
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Lima , 15036, Peru
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Lima , L41, Peru
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Lima , Lima , Peru
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Lima , LIMA , Peru
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Białystok , 15-54, Poland
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Kraków , 31-20, Poland
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Olsztyn , 10-35, Poland
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Otwock , 05-40, Poland
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Poznań , 60-56, Poland
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Szczecin , 71-45, Poland
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Warszawa , 02-78, Poland
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Warszawa , 04-14, Poland
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Wrocław , 53-43, Poland
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Kazan , 42002, Russian Federation
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Krasnoyarsk , 66013, Russian Federation
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Moscow , 10522, Russian Federation
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Moscow , 12120, Russian Federation
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Nizhniy Novgorod , 60308, Russian Federation
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Obninsk , 24903, Russian Federation
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Perm , 61499, Russian Federation
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Saint Petersburg , 19103, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Saint-Petersburg , 19775, Russian Federation
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St. Petersburg , 19702, Russian Federation
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Tomsk , 63406, Russian Federation
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Singapore , 30843, Singapore
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Barcelona , 08035, Spain
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Barcelona , 08036, Spain
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Madrid , 28040, Spain
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Majadahonda , 28222, Spain
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Málaga , 29010, Spain
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Bellinzona , 6500, Switzerland
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Winterthur , 8401, Switzerland
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Zürich , CH-80, Switzerland
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Taichung , 40201, Taiwan
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Taichung , 40447, Taiwan
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Tainan City , 73657, Taiwan
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Taipei City , 110, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 112, Taiwan
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Taipei , 235, Taiwan
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Bangkok , 10330, Thailand
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Bangkok , 10400, Thailand
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Chiang Mai , 50200, Thailand
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Khon Kaen , 40002, Thailand
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Pathumthani , 12120, Thailand
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Pathumwan , 10330, Thailand
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Phisanulok , 65000, Thailand
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Ankara , 06010, Turkey
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Ankara , 6500, Turkey
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Istanbul , 34010, Turkey
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Istanbul , 34214, Turkey
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Izmir , 35110, Turkey
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Malatya , 44280, Turkey
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Birmingham , B9 5S, United Kingdom
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Liverpool , L7 8Y, United Kingdom
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Manchester , M23 9, United Kingdom
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Hanoi , 10000, Vietnam
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Ho Chi Minh , 70000, 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:

328

Study ID:

NCT04351555

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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