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
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 and 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 (eg., 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 (including any known or suspected synchronous primary lung cancer), 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; Any synchronous Stage IA primary lung cancer that is ≤2 cm and planned to be resected during surgery for the Stage II to IIIB N2 lung tumour.
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 great vessels, the carina, the trachea, the oesophagus, the heart, and/or the vertebral body; 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)
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There are 211 Locations for this study
Birmingham Alabama, 35233, United States
Duarte California, 91010, United States
Irvine California, 92618, United States
Los Angeles California, 90048, United States
San Francisco California, 94143, United States
Santa Monica California, 90404, United States
Santa Rosa California, 95403, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States
Chicago Illinois, 60637, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Lebanon New Hampshire, 03756, United States
Commack New York, 11725, United States
New York New York, 10032, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98104, United States
Graz , 8036, Austria
Linz , 4020, Austria
Vienna , , Austria
Wien , 1210, Austria
Barretos , 14784, Brazil
Belo Horizonte , 30110, Brazil
Bento Goncalves , 95700, Brazil
Fortaleza , 60135, Brazil
Ibirapuera , 04501, Brazil
Jau , 17204, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90610, Brazil
Recife , 52010, Brazil
Ribeirão Preto , 14021, Brazil
Rio de Janeiro , 22271, Brazil
Santa Maria , 97015, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 01327, Brazil
São José do Rio Preto , 15090, Brazil
São Paulo , 04038, Brazil
Panagyurishte , 4500, Bulgaria
Pleven , 5804, Bulgaria
Plovdiv , 4004, Bulgaria
Sofia , 1113, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1527, Bulgaria
Sofia , 1618, Bulgaria
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H4A 3, Canada
Concepcion , 40701, Chile
Las Condes , 75609, Chile
Santiago , 75007, Chile
Santiago , 75009, Chile
Santiago , 75203, Chile
Santiago , 83804, Chile
Viña del Mar , 25404, Chile
Beijing , 10002, China
Beijing , 10002, China
Beijing , 10014, China
Beijing , 10019, China
Beijing , CN-10, China
Changchun , 13000, China
Changsha , 41000, China
Changsha , 41001, China
Chengdu , 61004, China
Chongqing , 40003, China
Guangzhou , 51006, China
Guangzhou , 51009, China
Guangzhou , 51012, China
Guangzhou , 51051, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31002, China
Hefei , 23000, China
Kunming , 65011, China
Linhai , 31700, China
Nanchang , 33000, China
Nanjing , 21002, China
Nantong , 22600, China
Shandong , , China
Shanghai , 20003, China
Shanghai , 20003, China
Shanghai , 20043, China
Shenyang , 11004, China
Shenzhen , 51805, China
Suzhou , 21500, China
Urumqi , 83000, China
Wanzhou , 40400, China
Wenzhou , CN-32, China
Xiamen , 36100, China
Yangzhou , 22500, China
Zhengzhou , 45000, China
Angers , 49033, France
Avignon Cedex , 84902, France
Bordeaux , 33000, France
Clermont Ferrand , 63011, France
Lyon , 69373, France
Toulon Cedex 9 , 83800, France
Berlin , 12351, Germany
Bielefeld , 33611, Germany
Esslingen a.N. , 73730, Germany
Freiburg , 79106, Germany
Gauting , 82131, Germany
Georgsmarienhuette , 49124, Germany
Halle , 06120, Germany
Hamburg , 21075, Germany
Heidelberg , 69126, Germany
Homburg , 66421, Germany
Köln , 51109, Germany
Oldenburg , 26121, Germany
Würzburg , 97067, Germany
Delhi , 11008, India
Kolkata , 70016, India
Manipal , 57610, India
Mumbai , 40001, India
Mumbai , 40003, India
Namakkal , 63700, India
New Delhi , 11002, India
Varanasi , 22100, India
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar Saba , 95847, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 62748, Israel
Bari , 70124, Italy
Firenze , 50134, Italy
Monza , 20900, Italy
Orbassano , 10043, Italy
Padova , 35128, Italy
Roma , 00144, Italy
Rozzano , 20089, Italy
Varese , 21100, Italy
Akashi-shi , 673-8, Japan
Bunkyo-ku , 113-8, Japan
Chiba-shi , 260-8, Japan
Hiroshima-shi , 734-8, Japan
Kashiwa , 227-8, Japan
Koto-ku , 135-8, Japan
Kyoto-shi , 606-8, Japan
Niigata-shi , 951-8, Japan
Osaka-shi , 541-8, Japan
Osakasayama-shi , 589-8, Japan
Sakai-shi , 591-8, Japan
Sendai-shi , 980-0, Japan
Shinjuku-ku , 160-0, Japan
Sunto-gun , 411-8, Japan
Yokohama-shi , 241-8, Japan
Daegu , 41404, Korea, Republic of
Hwasun-gun , 58128, Korea, Republic of
Incheon , 21431, Korea, Republic of
Seoul , 02447, Korea, Republic of
Seoul , 05030, Korea, Republic of
Seoul , 08308, Korea, Republic of
Seoul , 42601, Korea, Republic of
Yangsan-si , 50612, Korea, Republic of
Aguascalientes , 20230, Mexico
D.F , 14050, Mexico
Mexico City , '1408, Mexico
Mexico City , 06720, Mexico
La Libertad , 13013, Peru
Lima , 0051, Peru
Lima , 15036, Peru
Lima , 15038, Peru
Lima , L41, Peru
Lima , Lima , Peru
Lima , LIMA , Peru
Białystok , 15-54, Poland
Kraków , 31-20, Poland
Olsztyn , 10-35, Poland
Otwock , 05-40, Poland
Poznań , 60-56, Poland
Szczecin , 71-45, Poland
Warszawa , 02-78, Poland
Warszawa , 04-14, Poland
Wrocław , 53-43, Poland
Kazan , 42002, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Moscow , 10522, Russian Federation
Moscow , 12120, Russian Federation
Nizhniy Novgorod , 60308, Russian Federation
Obninsk , 24903, Russian Federation
Perm , 61499, Russian Federation
Saint Petersburg , 19103, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg , 19775, Russian Federation
St. Petersburg , 19702, Russian Federation
Tomsk , 63406, Russian Federation
Singapore , 30843, Singapore
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28040, Spain
Majadahonda , 28222, Spain
Málaga , 29010, Spain
Bellinzona , 6500, Switzerland
Winterthur , 8401, Switzerland
Zürich , CH-80, Switzerland
Taichung , 40201, Taiwan
Taichung , 40447, Taiwan
Tainan City , 73657, Taiwan
Taipei City , 110, Taiwan
Taipei , 10002, Taiwan
Taipei , 112, Taiwan
Taipei , 235, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Chiang Mai , 50200, Thailand
Khon Kaen , 40002, Thailand
Pathumthani , 12120, Thailand
Pathumwan , 10330, Thailand
Phisanulok , 65000, Thailand
Ankara , 06010, Turkey
Ankara , 06800, Turkey
Ankara , 6500, Turkey
Istanbul , 34010, Turkey
Istanbul , 34214, Turkey
Izmir , 35110, Turkey
Malatya , 44280, Turkey
Birmingham , B9 5S, United Kingdom
Liverpool , L7 8Y, United Kingdom
Manchester , M23 9, United Kingdom
Hanoi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
Ho Chi Minh , 70000, Vietnam
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