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 (SOLAR)

• ClinicalTrials.gov Identifier: NCT02588261
• Recruitment Status: Terminated
• First Posted: October 27, 2015
• Results First Posted: February 12, 2019
• Last Update Posted: February 12, 2019
• Sponsor: Astellas Pharma Global Development, Inc.
• Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer (NSCLC)	Drug: naquotinib mesilate; Drug: Erlotinib; Drug: Gefitinib	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 530 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: February 11, 2016
• Actual Primary Completion Date: December 21, 2017
• Actual Study Completion Date: December 21, 2017

Arms and Interventions

Arm	Intervention/treatment
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).	Drug: 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.; Other Name: ASP8273
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).	Drug: 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.; Other Names: Tarceva; OSI-774; Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival (PFS) as Assessed by Independent Radiologic Review (IRR) [ Time Frame: From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months) ]
   PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by IRR. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If progression or death occurred after missing 2 scheduled radiological assessments, the participant was censored at the date of last radiological assessment or at the date of randomization if no post-baseline radiological assessment was available.

Secondary Outcome Measures :

1. Percentage of Deaths [ Time Frame: From date of randomization up to data cut-off date 21 Dec 2017 (approximately 22 months) ]
   All events of death after the first study drug administration were included.
2. Percentage of Participants With Objective Response (OR) [ Time Frame: From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months) ]
   Percentage of participants with OR was defined as the proportion of participants with best overall response as complete response (CR) or partial response (PR) without confirmation based on the RECIST v1.1 as assessed by the blinded IRR. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.
3. PFS as Assessed by the Investigator [ Time Frame: From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months) ]
   PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on RECIST V1.1, as assessed by local investigator. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If progression or death occurred after missing 2 scheduled radiological assessments, the participant was censored at the date of last radiological assessment or at the date of randomization if no post-baseline radiological assessment was available.
4. Percentage of Participants With Disease Control [ Time Frame: From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months) ]
   Percentage of participants with disease control was defined as the proportion of participants whose best overall response was rated as CR, PR or stable disease (SD) among all analyzed participants based on RECIST V1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug.
5. Duration of Response (DOR) [ Time Frame: From date of first response up to data cut-off date 09 May 2017 (approximately 15 months) ]
   DOR was defined as the time from the date of the first response CR/PR (whichever was first recorded) as assessed by IRR to the date of radiographical progression or date of censoring. If a participant had not progressed, the participant was censored at the date of last radiological assessment or at the date of first CR/PR if no post-baseline radiological assessment was available. Results are based Kaplan-Meier estimate.
6. Number of Participants With Adverse Events (AEs) [ Time Frame: 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 ]
   Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.
7. Functional Assessment of Cancer Therapy - EGFR Inhibitors Subscale (FACT-EGFRI-18) Questionnaire [ Time Frame: Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months) ]
   ACT-EGFRI-18 is an 18-item Likert-scaled questionnaire, used to assess the effect of EGFR inhibitors on quality of life (QoL). The questionnaire is arranged in three HRQL dimensions: physical (seven items), social/emotional (six items), and functional well-being (five items). The response scores ranged from 0 to 4, and the response categories include "not at all", "a little bit", "somewhat", "quite a bit", and "very much." Negatively worded items (e.g., "My skin bleeds easily "or "My skin condition affects my mood") are reverse-scored, so that participants who experience a higher impact of symptom burden on HRQL receive a lower score (range 0-72).
8. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC-QLQ-LC13) [ Time Frame: Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months) ]
   The EORTC-QLQ-LC13 is a validated module of the EORTC-QLQ-Core 30, which includes module items that evaluate symptoms such as cough, hemoptysis, shortness of breath, sore mouth or tongue, dysphagia, tingling hands or feet, hair loss and pain. The total score for the questionnaire ranges from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
9. European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) [ Time Frame: Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months) ]
   EORTC-QLQ-LC30 is a 30-item cancer-specific questionnaire with multitrait scaling was used to create five functional domain scales: Physical, Role, Emotional, Social and Cognitive; two items evaluate global QoL; in addition, three symptom scales assess Fatigue, Pain and Emesis; and six single items assess other symptoms. The total score ranges from 0 to 100, with a high score for a functional scale representing a high/healthy level of functioning and a high score for a symptom scale or item representing a high level of symptomatology or problems.
10. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months) ]
    The EQ-5D is a generic preference-based measure that indirectly measures the utility for health that generates an index-based summary score based upon societal preference weights. The EQ-5D-5L consists of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale (VAS) for health status. Each item has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The VAS ranges from 0 (worst health status) and 100 (best health status).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

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.

Contacts and Locations

Locations

United States, California

Site US10029

Beverly Hills, California, United States, 90211

Site US10025

Fountain Valley, California, United States, 90806

Site US10036

La Jolla, California, United States, 92093

Site US10051

Loma Linda, California, United States, 92350

Site US10033

Los Angeles, California, United States, 90033

Site US10031

Oxnard, California, United States, 93030

Site US10052

Redondo Beach, California, United States, 90277

Site US10003

Santa Monica, California, United States, 90404

Site US10018

Whittier, California, United States, 90603

United States, Colorado

Site US10047

Glenwood Springs, Colorado, United States, 81601

United States, Florida

Site US10013

Aventura, Florida, United States, 33180

Site US10048

Saint Petersburg, Florida, United States, 33705

United States, Georgia

Site US10050

Atlanta, Georgia, United States, 30342

United States, Louisiana

Site US10042

Baton Rouge, Louisiana, United States, 70809

United States, Maine

Site US10037

Scarborough, Maine, United States, 04074

United States, Massachusetts

Site US10034

Boston, Massachusetts, United States, 02111

United States, Minnesota

Site US10030

Minneapolis, Minnesota, United States, 55455

Site US10027

Rochester, Minnesota, United States, 55905

United States, New Mexico

Site US10045

Albuquerque, New Mexico, United States, 87106

United States, New York

Site US10012

Mount Kisco, New York, United States, 10549

United States, Pennsylvania

Site US10021

Bethlehem, Pennsylvania, United States, 18015

United States, Tennessee

Site US10009

Nashville, Tennessee, United States, 37203

Site US10023

Nashville, Tennessee, United States, 37232

United States, Washington

Site US10011

Lacey, Washington, United States, 98503

United States, Wisconsin

Site US10046

Milwaukee, Wisconsin, United States, 53226

Australia, New South Wales

Site AU61003

Randwick, New South Wales, Australia, 2031

Australia, Queensland

Site AU61007

Woolloongabba, Queensland, Australia, 4102

Australia, South Australia

Site AU61005

Adelaide, South Australia, Australia, 5000

Australia, Victoria

Site AU61008

East Melbourne, Victoria, Australia, 3002

Site AU61002

Fitzroy, Victoria, Australia, 3065

Site AU61004

Footscray, Victoria, Australia, 3011

Belgium

Site BE32002

Gent, West-Vlaanderen, Belgium, 9000

Canada, Ontario

Site CA15006

Toronto, Ontario, Canada, M5G 2C4

Canada, Quebec

Site CA15002

Montreal, Quebec, Canada, H49 1C5

Chile

Site CL56001

Santiago, Región Metropolitana De Santia, Chile, 8380455

Site CL56002

Vina del Mar, Valparaíso, Chile, 2520612

Site CL56007

Vina del Mar, Valparaíso, Chile, 2540364

France

Site FR33010

Pessac, Gironde, France, 33604

Site FR33011

Suresnes, Hauts-de-Seine, France, 92150

Site FR33003

Creteil, Ilej-de-France, France, 94010

Site FR33004

Tours, Indre-et-Loire, France, 37044

Site FR33006

Grenoble, Isère, France, 38043

Site FR33009

Saint Priest en Jarez, Loire, France, 42270

Site FR33012

Bayonne, Pyrénées-Atlantiques, France, 64100

Site FR33007

Pierre Benite, Rhône, France, 69310

Germany

Site DE49008

Freiburg, Baden-Württemberg, Germany, 79106

Site DE49005

Karlsruhe, Baden-Württemberg, Germany, 76137

Site DE49003

Gauting, Bayern, Germany, 82131

Site DE49006

Wurzburg, Bayern, Germany, 97080

Site DE49007

Kassel, Hessen, Germany, 34125

Site DE49004

Köln, Nordrhein-Westfalen, Germany, 51109

Hungary

Site HU36002

Szekesfehervar, Fejér, Hungary, H 8000

Site HU36003

Tatabanya, Tatabánya, Hungary, H-2800

Site HU36006

Szombathely, Vas, Hungary, H 9700

Site HU36004

Farkasgyepu, Veszprém, Hungary, 8582

Site HU36007

Budapest, Hungary, 1121

Site HU36001

Budapest, Hungary, 1125

Italy

Site IT39004

Monza, Lombardia, Italy, 20052

Site IT39009

Rozzano, Lombardia, Italy, 20089

Site IT39011

Aviano, Pordenone, Italy, 33081

Site IT39003

Bergamo, Italy, 24127

Site IT39015

Brescia, Italy, 25123

Site IT39002

Cremona, Italy, 26100

Site IT39013

Lucca, Italy, 55100

Site IT39014

Milano, Italy, 20142

Site IT39012

Piacenza, Italy, 29100

Site IT39008

Roma, Italy, 00128

Japan

Site JP81018

Matsuyama, Ehime, Japan, 791-0280

Site JP81013

Hiroshima, Hirosima [Hiroshima], Japan, 730-8518

Site JP81014

Sapporo, Hokkaidô, Japan, 003-0804

Site JP81017

Osakasayama-shi, Hukuoka [Fukuoka], Japan, 589-8511

Site JP81008

Kurume, Hukuoka, Japan, 830-0011

Site JP81024

Kobe, Hyogo, Japan, 650-0047

Site JP81015

Kanazawa, Isikawa [Ishikawa], Japan, 920-8530

Site JP81010

Yokohama, Kanagawa, Japan, 236-0051

Site JP81025

Yokohama, Kanagawa, Japan, 241-8515

Site JP81012

Sendai, Miyagi, Japan, 980-0873

Site JP81016

Kurashiki, Okayama, Japan, 710-8602

Site JP81005

Miyakojima-ku, Osaka, Japan, 534-0021

Site JP81020

Osakasayama-shi, Osaka, Japan, 569-8511

Site JP81019

Sunto-gun, Shizuoka, Japan, 411-8777

Site JP81001

Sunto-gun, Sizuoka [Shizuoka], Japan, 411-8777

Site JP81004

Tokyo, Tôkyô [Tokyo], Japan, 135-8550

Site JP81022

Niigata, Japan, 951-8122

Site JP81006

Okayama, Japan, 700-8558

Site JP81023

Wakayama, Japan, 641-8510

Site JP81021

Hirakata, Ôsaka [Osaka], Japan, 573-1191

Site JP81002

Osaka-sayama, Ôsaka [Osaka], Japan, 589-8511

Korea, Republic of

Site KR82005

Cheongiu, Chungcheongbugdo, Korea, Republic of, 28644

Site KR82004

Suwon-si, Gyeonggi-do, Korea, Republic of, 16499

Site KR82016

Suwon-si, Gyeonggido [Kyonggi-do], Korea, Republic of, 16427

Site KR82017

Bundang, Gyeonggido, Korea, Republic of, 13620

Site KR82009

Jinju-si, Gyeongsangnamdo, Korea, Republic of, 660-702

Site KR82003

Jeonju, Jeonrabugdo[Chollabuk-do], Korea, Republic of, 54907

Site KR82002

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of, 028-481

Site KR82001

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of, 05505

Site KR82013

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of, 135-720

Site KR82007

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of, 139-706

Site KR82008

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of, 152-703

Site KR82006

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of, 156-707

Site KR82015

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of, 5368

Site KR82014

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 130-701

Site KR82011

Ulsan, Ulsan Gwang'yeogsi, Korea, Republic of, 682-714

Site KR82010

Busan Gwang'yeogsi, Korea, Republic of, 48108

Malaysia

Site MY60001

Kuantan Pahang, Pahang, Malaysia, 25100

Site MY60002

Georgetown, Pulau Pinang, Malaysia, 10450

Site MY60004

Kuching, Sarawak, Malaysia, 93586

Netherlands

Site NL31001

Arnhem, Gelderland, Netherlands, 6815 AD

Site NL31006

Alkmaar, Noord-Holland, Netherlands, 1815 JD

Peru

Site PE51001

Cercado De Lima, Arequipa, Peru, 04001

Site PE51008

Miraflores, Lima, Peru, L18

Site PE51004

San Isidro, Lima, Peru, 1501

Portugal

Site PT35101

Amadora, Lisboa, Portugal, 2720-276

Site PT35104

Lisbon, Lisboa, Portugal, 1099-023

Site PT35103

Coimbra, Portugal, 3041-801

Site PT35102

Lisboa, Portugal, 1400-038

Romania

Site RO40004

Floresti, Cluj, Romania, 407280

Site RO40001

Craiova, Dolj, Romania, 200347

Site RO40010

Craiova, Dolj, Romania, 200385

Site RO40007

Ploiesti, Prahova, Romania, 100010

Site RO40008

Timisoara, Timis, Romania, 300210

Site RO40012

Bucuresti, Romania, 031422

Site RO40006

Sibiu, Romania, 550245

Russian Federation

Site RU70012

Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation, 163045

Site RU70017

Ufa, Bashkortostan, Russian Federation, 450054

Site RU70009

Magnitogorsk, Chelyabinskaya Oblast', Russian Federation, 455001

Site RU70016

Nalchik, Kabardino-Balkarskaya Respublika, Russian Federation, 360000

Site RU70008

Pyatigorsk, Stavropol'skiy Kray, Russian Federation, 357502

Site RU70001

Saint Petersburg, Russian Federation, 197022

Singapore

Site SG65001

Singapore, Central Singapore, Singapore, 188770

Site SG65002

Singapore, Central Singapore, Singapore, 308433

Spain

Site ES34003

Barcelona, Catalunya, Spain, 08036

Site ES34008

San Sebastian, Guipuzcoa, Guipúzcoa, Spain, 20014

Site ES34010

Malaga, Málaga, Spain, 29010

Site ES34006

Madrid, Spain, 28046

Site ES34016

Madrid, Spain, 28050

Site ES34004

Ourense, Spain, 32004

Site ES34005

Sevilla, Spain, 41009

Site ES34015

Valencia, Spain, 46010

Site ES34017

Valencia, Spain, 46014

Site ES34002

Valencia, Spain, 46026

Taiwan

Site TW88605

Taichung City, Taichung, Taiwan, 40447

Site TW88607

Taoyuan Hsien, Taoyuan, Taiwan, 33305

Site TW88606

Kaohsiung, Taiwan, 83301

Site TW88603

Taichung, Taiwan, 40705

Site TW88601

Tainan, Taiwan, 70403

Site TW88604

Tainan, Taiwan, 736

Site TW88608

Taipei, Taiwan, 100

Site TW88609

Taipei, Taiwan, 11217

Site TW88611

Taipei, Taiwan, 11490

Thailand

Site TH66011

Chom Thong, Chiang Mai, Thailand, 50200

Site TH66001

Bangkok, Krung Thep Maha Nakhon [Bangkok], Thailand, 10330

Site TH66012

Bangkok, Krung Thep Maha Nakhon [Bangkok], Thailand, 10400

Site TH66002

Chiang Rai, Thailand, 57000

Site TH66004

Khon Kaen, Thailand, 40002

Site TH66006

Songkla, Thailand, 90110

Ukraine

Site UA38006

Chernivtsi, Chernivets'ka Oblast', Ukraine, 58013

Site UA38001

Dnipropetrovsk, Dnipropetrovs'ka Oblast', Ukraine, 49102

Site UA38005

Kryvyi Rih, Dnipropetrovs'ka Oblast', Ukraine, 50048

Site UA38008

Ivano-Frankivsk, Ivano-Frankivs'ka Oblast', Ukraine, 76000

Site UA38004

Lviv, L'vivs'ka Oblast', Ukraine, 79031

Site UA38007

Lutsk, Volyns'ka Oblast', Ukraine, 43018

Site UA38009

Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88000

Site UA38003

Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88014

United Kingdom

Site GB44002

Middlesex, Hertfordshire, United Kingdom, HA6 2RN

Site GB44001

Liverpool, Wirral, United Kingdom, CH63 4JY

Site GB44003

Sheffield, United Kingdom, S10 2SJ

Sponsors and Collaborators

Astellas Pharma Global Development, Inc.

Investigators

• Study Director: Medical Monitor; Astellas Pharma Global Development, Inc.

  Study Documents (Full-Text)

Documents provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

Study Protocol  [PDF] February 19, 2016

Statistical Analysis Plan  [PDF] August 11, 2016

More Information

Additional Information:

Link to results on the Astellas Clinical Study Results website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Astellas Pharma Global Development, Inc.
• ClinicalTrials.gov Identifier: NCT02588261
• Other Study ID Numbers: 8273-CL-0302; 2015-002894-39 ( EudraCT Number )
• First Posted: October 27, 2015
• Results First Posted: February 12, 2019
• Last Update Posted: February 12, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com

:

• Supporting Materials: Study Protocol; Clinical Study Report (CSR)
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data..
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• URL: https://www.clinicalstudydatarequest.com/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

erlotinib; EGFR mutation; naquotinib; Non-small cell lung cancer (NSCLC); ASP8273; gefitinib

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Erlotinib Hydrochloride; Gefitinib; Naquotinib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action