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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02588261




Registration number
NCT02588261
Ethics application status
Date submitted
26/10/2015
Date registered
27/10/2015
Date last updated
12/02/2019

Titles & IDs
Public title
A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
Scientific title
An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
Secondary ID [1] 0 0
2015-002894-39
Secondary ID [2] 0 0
8273-CL-0302
Universal Trial Number (UTN)
Trial acronym
SOLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - naquotinib mesilate
Treatment: Drugs - Erlotinib
Treatment: Drugs - Gefitinib

Experimental: ASP8273 - Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).

Active comparator: erlotinib or gefitinib - Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).


Treatment: Drugs: naquotinib mesilate
Participants received ASP8273 300 mg orally once daily on an empty stomach (no food for at least 2 hours before and 1 hour after taking drug) at approximately the same time every day.

Treatment: Drugs: Erlotinib
Participants received erlotinib 150 mg orally once daily on an empty stomach (no food for at least 2 hours before and 1 hour after taking drug) at approximately the same time every day. At the beginning of the trial, prior to site initiation and shipment of study drug supplies, each investigator selected either erlotinib or gefitinib to be utilized for all participants randomized to the comparator arm at their site.

Treatment: Drugs: Gefitinib
Participants received gefitinib 250 mg was taken orally once daily with water, with or without food, at approximately the same time every day. At the beginning of the trial, prior to site initiation and shipment of study drug supplies, each investigator selected either erlotinib or gefitinib to be utilized for all participants randomized to the comparator arm at their site.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Assessed by Independent Radiologic Review (IRR)
Timepoint [1] 0 0
From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)
Secondary outcome [1] 0 0
Percentage of Deaths
Timepoint [1] 0 0
From date of randomization up to data cut-off date 21 Dec 2017 (approximately 22 months)
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response (OR)
Timepoint [2] 0 0
From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)
Secondary outcome [3] 0 0
PFS as Assessed by the Investigator
Timepoint [3] 0 0
From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)
Secondary outcome [4] 0 0
Percentage of Participants With Disease Control
Timepoint [4] 0 0
From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
From date of first response up to data cut-off date 09 May 2017 (approximately 15 months)
Secondary outcome [6] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [6] 0 0
From first dose of study drug up to 30 days after last dose of study drug taken up to data cut-off 09 May 2017
Secondary outcome [7] 0 0
Functional Assessment of Cancer Therapy - EGFR Inhibitors Subscale (FACT-EGFRI-18) Questionnaire
Timepoint [7] 0 0
Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)
Secondary outcome [8] 0 0
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC-QLQ-LC13)
Timepoint [8] 0 0
Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)
Secondary outcome [9] 0 0
European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)
Timepoint [9] 0 0
Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)
Secondary outcome [10] 0 0
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Timepoint [10] 0 0
Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)

Eligibility
Key inclusion criteria
* Subject agrees not to participate in another interventional study while on treatment.
* Female subject must either:

* Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile
* Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; And have a negative serum pregnancy test at Screening; And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least 1 of which must be a highly effective method and one must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
* Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
* Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
* Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.
* Male subject must not donate sperm starting at Screening and throughout the study period and for 90 days after the final study drug administration.
* Subject has Eastern Cooperative Oncology Group (ECOG) performance status = 2.
* Subject has histologically confirmed locally advanced, metastatic or unresectable Stage IIIB/IV adenocarcinoma NSCLC (newly diagnosed or recurrent). Subjects with mixed histology are eligible if adenocarcinoma is the predominant histology.
* Subject has predicted life expectancy = 12 weeks in the opinion of the investigator.
* Subject must meet all of the following criteria on the laboratory tests that will be analyzed centrally within 7 days prior to the first dose of study drug. In case of multiple laboratory data within this period, the most recent data should be used.

* Neutrophil count > 1,000/mm3
* Platelet count = 7.5 x 104 /mm3
* Hemoglobin > 8.0 g/dL
* Serum creatinine ? 2.0 x upper limit of normal (ULN) or an estimated glomerular filtration rate (eGFR) of > 50 mL/min as calculated by the Cockcroft Gault Method
* Total bilirubin ?1.5 x ULN (except for subjects with documented Gilbert's syndrome)
* AST and ALT ? 3.0 x ULN or = 5 x ULN if subject has documented liver metastases
* Serum sodium level is = 130 mmol/L
* Subject has an EGFR activating mutation (exon 19 deletion or exon 21 L858R), with or without T790M mutation, by local or central testing on examination of a NSCLC FFPE specimen (archival or fresh biopsy). Subjects harboring both exon 19 deletion and exon 21 L858R mutations are not eligible. A tissue sample from the same block used to determine eligibility by local testing should be available to send to the central lab for confirmatory testing. Subjects randomized based on local results indicating presence of EGFR mutation may remain on study if central results are discordant.
* Subject must have at least 1 measureable lesion based on RECIST V1.1. Previously irradiated lesions will not be considered as measurable lesions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has received intervening anticancer treatment or previous treatment with chemotherapy for metastatic disease other than palliative local radiation to painful bone metastases completed at least 1 week prior to the first dose of study drug. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized = 6 months before the first dose of study drug.
* Subject has received a prior treatment with a therapeutic agent targeting EGFR (e.g., afatinib, dacomitinib, ASP8273, etc).
* Subject has received investigational therapy within 28 days or 5 half-lives prior to the first dose of study drug.
* Subject has received radiotherapy within 1 week prior to the first dose of study drug. If the subject received radiotherapy > 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.
* Subject has symptomatic central nervous system (CNS) metastasis. Subject with previously treated brain or CNS metastases are eligible provided that the subject has recovered from any acute effects of radiotherapy, does not have brain metastasis related symptoms, is not requiring systemic steroids for at least 2 weeks prior to study drug administration, and any whole brain radiation therapy was completed at least 4 weeks prior to study drug administration, or any stereotactic radiosurgery (SRS) was completed at least 2 weeks prior to study drug administration. Steroid inhaler use or ointment treatment for other concomitant medical disease is permitted.
* Subject has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug.
* Subject has had a major surgical procedure (other than a biopsy) within 14 days prior to the first dose of study drug, or one is planned during the course of the study.
* Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection.
* Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP8273, erlotinib or gefitinib.
* Subject has evidence of an active infection requiring systemic therapy within 14 days prior to the planned first dose of study drug.
* Subject has severe or uncontrolled systemic diseases including uncontrolled hypertension (blood pressure > 150/100 mmHg) or active bleeding diatheses.
* Subject has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD.
* Subject has ongoing cardiac arrhythmia that is Grade = 2 or uncontrolled atrial fibrillation of any grade.
* Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.
* Subject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the planned first dose of study drug.
* Subject has history of gastrointestinal ulcer or gastrointestinal bleeding within 3 months prior to the planned first dose of study drug.
* Subject has concurrent corneal disorder or any ophthalmologic condition which, in the investigator's opinion, makes the subject unsuitable for study participation (i.e., advanced cataracts, glaucoma).
* Subject has difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drug.
* Subject has another past or active malignancy which requires treatment. Prior carcinoma in situ or non-melanoma skin cancer after curative resection are permitted.
* Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation.
* Subject has received potent CYP 3A4 inhibitors within 7 days prior to first dose of study drug or proton pump inhibitors such as omeprazole within 14 days prior to first dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2017
Sample size
Target
Accrual to date
Final
530
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Site AU61003 - Randwick
Recruitment hospital [2] 0 0
Site AU61007 - Woolloongabba
Recruitment hospital [3] 0 0
Site AU61005 - Adelaide
Recruitment hospital [4] 0 0
Site AU61008 - East Melbourne
Recruitment hospital [5] 0 0
Site AU61002 - Fitzroy
Recruitment hospital [6] 0 0
Site AU61004 - Footscray
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
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Florida
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United States of America
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Georgia
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Louisiana
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Maine
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Massachusetts
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Minnesota
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New York
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Pennsylvania
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Tennessee
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Washington
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United States of America
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Wisconsin
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Belgium
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West-Vlaanderen
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Región Metropolitana De Santia
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Chile
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Valparaíso
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France
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Gironde
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France
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Hauts-de-Seine
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France
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Ilej-de-France
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France
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Indre-et-Loire
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France
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Isère
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Loire
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Pyrénées-Atlantiques
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Rhône
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Germany
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Baden-Württemberg
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Bayern
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Hessen
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Nordrhein-Westfalen
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Fejér
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Tatabánya
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Vas
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Pordenone
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Milano
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Hukuoka
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Hyogo
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Isikawa [Ishikawa]
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Kanagawa
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Miyagi
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Okayama
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Osaka
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Shizuoka
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Sizuoka [Shizuoka]
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Tôkyô [Tokyo]
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Niigata
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Wakayama
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Ôsaka [Osaka]
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Korea, Republic of
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Korea, Republic of
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Gyeonggi-do
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Gyeonggido [Kyonggi-do]
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Gyeongsangnamdo
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Korea, Republic of
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Jeonrabugdo[Chollabuk-do]
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Korea, Republic of
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Seoul Teugbyeolsi [Seoul-T'ukp]
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Ulsan Gwang'yeogsi
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Korea, Republic of
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Busan Gwang'yeogsi
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Malaysia
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Pahang
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Malaysia
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Pulau Pinang
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Malaysia
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Sarawak
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Netherlands
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Gelderland
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Netherlands
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Noord-Holland
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Peru
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Arequipa
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Peru
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Lima
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Portugal
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Lisboa
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Portugal
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Coimbra
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Prahova
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Romania
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Timis
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Romania
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Bucuresti
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Romania
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Sibiu
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Russian Federation
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Arkhangel'skaya Oblast'
Country [89] 0 0
Russian Federation
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Bashkortostan
Country [90] 0 0
Russian Federation
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Chelyabinskaya Oblast'
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Kabardino-Balkarskaya Respublika
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Russian Federation
State/province [92] 0 0
Stavropol'skiy Kray
Country [93] 0 0
Russian Federation
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Saint Petersburg
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Singapore
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Central Singapore
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Spain
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Catalunya
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Spain
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Guipúzcoa
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Spain
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Málaga
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Spain
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Madrid
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Spain
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Ourense
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Taichung
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Taiwan
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Taoyuan
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Taiwan
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Kaohsiung
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Taiwan
State/province [105] 0 0
Tainan
Country [106] 0 0
Taiwan
State/province [106] 0 0
Taipei
Country [107] 0 0
Thailand
State/province [107] 0 0
Chiang Mai
Country [108] 0 0
Thailand
State/province [108] 0 0
Krung Thep Maha Nakhon [Bangkok]
Country [109] 0 0
Thailand
State/province [109] 0 0
Chiang Rai
Country [110] 0 0
Thailand
State/province [110] 0 0
Khon Kaen
Country [111] 0 0
Thailand
State/province [111] 0 0
Songkla
Country [112] 0 0
Ukraine
State/province [112] 0 0
Chernivets'ka Oblast'
Country [113] 0 0
Ukraine
State/province [113] 0 0
Dnipropetrovs'ka Oblast'
Country [114] 0 0
Ukraine
State/province [114] 0 0
Ivano-Frankivs'ka Oblast'
Country [115] 0 0
Ukraine
State/province [115] 0 0
L'vivs'ka Oblast'
Country [116] 0 0
Ukraine
State/province [116] 0 0
Volyns'ka Oblast'
Country [117] 0 0
Ukraine
State/province [117] 0 0
Zakarpats'ka Oblast'
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Hertfordshire
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Wirral
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.
Trial website
https://clinicaltrials.gov/study/NCT02588261
Trial related presentations / publications
Kelly RJ, Shepherd FA, Krivoshik A, Jie F, Horn L. A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer. Ann Oncol. 2019 Jul 1;30(7):1127-1133. doi: 10.1093/annonc/mdz128.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Astellas Pharma Global Development, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02588261