Lung Cancer Clinical Trial

AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary

A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

View Full Description

Full Description

This is a phase III, open label, randomized study assessing Osimertinib (80 mg, orally, once daily) versus platinum-based doublet chemotherapy (standard of care) in subjects with confirmed diagnosis of Epidermal Growth Factor Receptor (EGFR) mutation positive NSCLC, who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent and whose tumours harbour a T790M mutation within the EGFR Gene. Subjects must be chemotherapy naive and must agree to provide a biopsy for central confirmation of T790 mutation status following confirmed disease progression on their first line EGFR-TKI treatment (e.g. erlotinib, gefitinib or afatinib). Suitable subjects will then be randomized to receive either Osimertinib (80mg orally, once daily) or platinum-based doublet chemotherapy (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve AUC 5 or pemetrexed 500 mg/m2 + cisplatin 75 mg/m2) on Day 1 of every 21-day cycle in a 2:1 (Osimertinib: platinum-based doublet chemotherapy) ratio. Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review, they will be given the opportunity to begin treatment with Osimertinib 80mg, once daily. These subjects may continue treatment with Osimertinib even after disease progression, as long as they are continuing to show clinical benefit, as judged by the investigator. The primary objective of the study is to assess the efficacy of Osimertinib compared with platinum-based doublet chemotherapy by assessment of Progression Free Survival (PFS), using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1), as well as asensitivity analysis of Progression Free Survival using Blinded Independent Central Review (BICR).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subjects with histologically or cytologically documented NSCLC.
Locally advanced or metastatic NSCLC
Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
Eligible to receive treatment with the selected doublet-chemotherapy
Central confirmation of T790M+ mutation status
World Health Organization (WHO) performance status 0-1
At least one lesion, not previously irradiated.

Exclusion Criteria:

• Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
Treatment with more than one prior line of treatment for advanced NSCLC
Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment
Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
Previous treatment with Osimertinib, or a 3rd generation EGFR TKI

For subjects who cross-over to Osimertinib:

Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review.
At least 14 days since last dose of platinum-based doublet chemotherapy

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

419

Study ID:

NCT02151981

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 146 Locations for this study

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Anaheim California, 92801, United States
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Orange California, 92868, United States
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Santa Rosa California, 95403, United States
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Norwalk Connecticut, 06856, United States
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Gainesville Florida, 32610, United States
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Orlando Florida, 32804, United States
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Pembroke Pines Florida, 33028, United States
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Atlanta Georgia, 30322, United States
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Park Ridge Illinois, 60068, United States
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Indianapolis Indiana, 46202, United States
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Marrero Louisiana, 70072, United States
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Chevy Chase Maryland, 20815, United States
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Lebanon New Hampshire, 03756, United States
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Brick New Jersey, 08724, United States
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New York New York, 10032, United States
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Hershey Pennsylvania, 17033, United States
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Charleston South Carolina, 29425, United States
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Houston Texas, 77030, United States
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Lacey Washington, 98503, United States
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Tacoma Washington, 98405, United States
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Milwaukee Wisconsin, 53226, United States
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Darlinghurst , 2010, Australia
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Heidelberg , 3084, Australia
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Kogarah , 2217, Australia
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Nedlands , 6009, Australia
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Woolloongabba , 4102, Australia
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Edmonton Alberta, T6G 1, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Halifax Nova Scotia, B3H 1, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H2L 4, Canada
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Beijing , 10002, China
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Beijing , 10014, China
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Changchun , 13000, China
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Chongqing , 40003, China
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Chongqing , 40004, China
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Fuzhou , 35001, China
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Guangzhou , 51006, China
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Guangzhou , 51010, China
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Hangzhou , 31000, China
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Harbin , 15004, China
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Nanchang , 33000, China
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Shanghai , 20003, China
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Shanghai , CN-20, China
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Tianjin , 30006, China
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Zhengzhou , 45000, China
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Ürümqi , 83000, China
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Clermont Ferrand , 63003, France
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Dijon , 21079, France
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Lille , 59000, France
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Marseille Cedex 20 , 13915, France
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Paris , 75020, France
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Strasbourg Cedex , 67091, France
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Toulouse Cedex 09 , 31059, France
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Villejuif , 94800, France
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Essen , 45122, Germany
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Frankfurt , 60590, Germany
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Gerlingen , 70839, Germany
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Oldenburg , 26121, Germany
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Regensburg , 93053, Germany
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Würzburg , 97080, Germany
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Hong Kong , , Hong Kong
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Shatin , 00000, Hong Kong
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Budapest , 1121, Hungary
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Avellino , 83100, Italy
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Meldola , 47014, Italy
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Milano , 20133, Italy
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Orbassano , 10043, Italy
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Roma , 00128, Italy
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Akashi-shi , 673-8, Japan
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Bunkyo-ku , 113-8, Japan
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Fukuoka , 812-8, Japan
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Hirakata-shi , 573-1, Japan
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Kanazawa , 920-8, Japan
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Kitaadachi-gun , 362-0, Japan
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Kobe-shi , 650-0, Japan
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Kurashiki-shi , 710-8, Japan
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Kyoto-shi , 606-8, Japan
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Matsuyama-shi , 791-0, Japan
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Nagoya-shi , 464-8, Japan
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Natori-shi , 981-1, Japan
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Niigata-shi , 951-8, Japan
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Okayama-shi , 700-8, Japan
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Osaka-shi , 534-0, Japan
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Osaka-shi , 541-8, Japan
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Osakasayama , 589-8, Japan
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Sakai-shi , 591-8, Japan
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Shinjuku-ku , 160-0, Japan
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Sunto-gun , 411-8, Japan
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Takatsuki-shi , 569-8, Japan
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Wakayama-shi , 641-8, Japan
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Yokohama-shi , 236-0, Japan
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Yokohama-shi , 236-0, Japan
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Yokohama-shi , 241-8, Japan
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Busan , 47392, Korea, Republic of
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Cheongju-si , 28644, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Incheon , 21565, Korea, Republic of
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Jinju-si , 660-7, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Seoul , 156-7, Korea, Republic of
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Seoul , 6351, Korea, Republic of
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Suwon-si , 16499, Korea, Republic of
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Ulsan , 44033, Korea, Republic of
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Mexico , 52763, Mexico
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Oaxaca , 68000, Mexico
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Amsterdam , 1066 , Netherlands
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Amsterdam , 1081 , Netherlands
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Groningen , 9713 , Netherlands
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Ekaterinburg , 62090, Russian Federation
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Moscow , 11547, Russian Federation
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Omsk , 64401, Russian Federation
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Saint Petersburg, , 19775, Russian Federation
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Saint Petersburg , 19734, Russian Federation
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Saint-Petersburg , 19718, Russian Federation
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Madrid , 08035, Spain
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Madrid , 28034, Spain
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Madrid , 28041, Spain
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Málaga , 29010, Spain
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Sevilla , 41013, Spain
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Zaragoza , 50009, Spain
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Göteborg , 413 4, Sweden
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Lund , 221 8, Sweden
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Stockholm , 171 7, Sweden
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Changhua , 500, Taiwan
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Hsinchu , 300, Taiwan
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Kaohsiung City , 83301, Taiwan
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Kaohsiung , 81362, Taiwan
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Kaohsiung , 82445, Taiwan
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Taichung , 40447, Taiwan
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Taichung , 40705, Taiwan
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Tainan , 704, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 112, Taiwan
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Taoyuan , 333, Taiwan
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Aberdeen , AB2 2, United Kingdom
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Bristol , BS2 8, United Kingdom
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Glasgow , G12 0, United Kingdom
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Huddersfield , HD3 3, United Kingdom
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London , SW10 , United Kingdom
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London , W1G 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Newcastle-Upon-Tyne , NE7 7, United Kingdom
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Nottingham , NG5 1, United Kingdom
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Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

419

Study ID:

NCT02151981

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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