Study Stopped
Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies
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
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
2 other identifiers
interventional
530
23 countries
167
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2016
167 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2015
CompletedFirst Posted
Study publicly available on registry
October 27, 2015
CompletedStudy Start
First participant enrolled
February 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2017
CompletedResults Posted
Study results publicly available
February 12, 2019
CompletedDecember 10, 2024
November 1, 2024
1.9 years
October 26, 2015
December 10, 2018
November 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) as Assessed by Independent Radiologic Review (IRR)
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.
From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)
Secondary Outcomes (10)
Percentage of Deaths
From date of randomization up to data cut-off date 21 Dec 2017 (approximately 22 months)
Percentage of Participants With Objective Response (OR)
From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)
PFS as Assessed by the Investigator
From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)
Percentage of Participants With Disease Control
From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)
Duration of Response (DOR)
From date of first response up to data cut-off date 09 May 2017 (approximately 15 months)
- +5 more secondary outcomes
Study Arms (2)
ASP8273
EXPERIMENTALParticipants 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).
erlotinib or gefitinib
ACTIVE COMPARATORParticipants 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).
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (167)
Site US10029
Beverly Hills, California, 90211, United States
Site US10025
Fountain Valley, California, 90806, United States
Site US10036
La Jolla, California, 92093, United States
Site US10051
Loma Linda, California, 92350, United States
Site US10033
Los Angeles, California, 90033, United States
Site US10031
Oxnard, California, 93030, United States
Site US10052
Redondo Beach, California, 90277, United States
Site US10003
Santa Monica, California, 90404, United States
Site US10018
Whittier, California, 90603, United States
Site US10047
Glenwood Springs, Colorado, 81601, United States
Site US10013
Aventura, Florida, 33180, United States
Site US10048
St. Petersburg, Florida, 33705, United States
Site US10050
Atlanta, Georgia, 30342, United States
Site US10042
Baton Rouge, Louisiana, 70809, United States
Site US10037
Scarborough, Maine, 04074, United States
Site US10034
Boston, Massachusetts, 02111, United States
Site US10030
Minneapolis, Minnesota, 55455, United States
Site US10027
Rochester, Minnesota, 55905, United States
Site US10045
Albuquerque, New Mexico, 87106, United States
Site US10012
Mount Kisco, New York, 10549, United States
Site US10021
Bethlehem, Pennsylvania, 18015, United States
Site US10009
Nashville, Tennessee, 37203, United States
Site US10023
Nashville, Tennessee, 37232, United States
Site US10011
Lacey, Washington, 98503, United States
Site US10046
Milwaukee, Wisconsin, 53226, United States
Site AU61003
Randwick, New South Wales, 2031, Australia
Site AU61007
Woolloongabba, Queensland, 4102, Australia
Site AU61005
Adelaide, South Australia, 5000, Australia
Site AU61008
East Melbourne, Victoria, 3002, Australia
Site AU61002
Fitzroy, Victoria, 3065, Australia
Site AU61004
Footscray, Victoria, 3011, Australia
Site BE32002
Ghent, West-Vlaanderen, 9000, Belgium
Site CA15006
Toronto, Ontario, M5G 2C4, Canada
Site CA15002
Montreal, Quebec, H49 1C5, Canada
Site CL56002
Viña del Mar, Región de Valparaíso, 2520612, Chile
Site CL56007
Viña del Mar, Región de Valparaíso, 2540364, Chile
Site CL56001
Santiago, Región Metropolitana de Santia, 8380455, Chile
Site FR33010
Pessac, Gironde, 33604, France
Site FR33011
Suresnes, Hauts-de-Seine, 92150, France
Site FR33003
Créteil, Ilej-de-France, 94010, France
Site FR33004
Tours, Indre-et-Loire, 37044, France
Site FR33006
Grenoble, Isère, 38043, France
Site FR33009
Saint Priest En Jarez, Pays de la Loire Region, 42270, France
Site FR33012
Bayonne, Pyrénées-Atlantiques, 64100, France
Site FR33007
Pierre-Bénite, Rhône, 69310, France
Site DE49008
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Site DE49005
Karlsruhe, Baden-Wurttemberg, 76137, Germany
Site DE49003
Gauting, Bavaria, 82131, Germany
Site DE49006
Würzburg, Bavaria, 97080, Germany
Site DE49007
Kassel, Hesse, 34125, Germany
Site DE49004
Cologne, North Rhine-Westphalia, 51109, Germany
Site HU36002
Székesfehérvár, Fejér, H 8000, Hungary
Site HU36003
Tatabánya, Tatabánya, H-2800, Hungary
Site HU36006
Szombathely, Vas County, H 9700, Hungary
Site HU36004
Farkasgyepű, Veszprém megye, 8582, Hungary
Site HU36007
Budapest, 1121, Hungary
Site HU36001
Budapest, 1125, Hungary
Site IT39004
Monza, Lombardy, 20052, Italy
Site IT39009
Rozzano, Lombardy, 20089, Italy
Site IT39011
Aviano, Pordenone, 33081, Italy
Site IT39003
Bergamo, 24127, Italy
Site IT39015
Brescia, 25123, Italy
Site IT39002
Cremona, 26100, Italy
Site IT39013
Lucca, 55100, Italy
Site IT39014
Milan, 20142, Italy
Site IT39012
Piacenza, 29100, Italy
Site IT39008
Roma, 00128, Italy
Site JP81018
Matsuyama, Ehime, 791-0280, Japan
Site JP81013
Hiroshima, Hirosima [Hiroshima], 730-8518, Japan
Site JP81014
Sapporo, Hokkaidô, 003-0804, Japan
Site JP81017
Osakasayama-shi, Hukuoka [Fukuoka], 589-8511, Japan
Site JP81008
Kurume, Hukuoka, 830-0011, Japan
Site JP81024
Kobe, Hyōgo, 650-0047, Japan
Site JP81015
Kanazawa, Isikawa [Ishikawa], 920-8530, Japan
Site JP81010
Yokohama, Kanagawa, 236-0051, Japan
Site JP81025
Yokohama, Kanagawa, 241-8515, Japan
Site JP81012
Sendai, Miyagi, 980-0873, Japan
Site JP81016
Kurashiki, Okayama-ken, 710-8602, Japan
Site JP81005
Miyakojima-ku, Osaka, 534-0021, Japan
Site JP81020
Osakasayama-shi, Osaka, 569-8511, Japan
Site JP81019
Sunto-gun, Shizuoka, 411-8777, Japan
Site JP81001
Sunto-gun, Sizuoka [Shizuoka], 411-8777, Japan
Site JP81004
Tokyo, Tôkyô [Tokyo], 135-8550, Japan
Site JP81022
Niigata, 951-8122, Japan
Site JP81006
Okayama, 700-8558, Japan
Site JP81023
Wakayama, 641-8510, Japan
Site JP81021
Hirakata, Ôsaka [Osaka], 573-1191, Japan
Site JP81002
Ōsaka-sayama, Ôsaka [Osaka], 589-8511, Japan
Site MY60001
Kuantan Pahang, Pahang, 25100, Malaysia
Site MY60002
George Town, Pulau Pinang, 10450, Malaysia
Site MY60004
Kuching, Sarawak, 93586, Malaysia
Site NL31001
Arnhem, Gelderland, 6815 AD, Netherlands
Site NL31006
Alkmaar, North Holland, 1815 JD, Netherlands
Site PE51001
Cercado de Lima, Arequipa, 04001, Peru
Site PE51008
Miraflores, Lima region, L18, Peru
Site PE51004
San Isidro, Lima region, 1501, Peru
Site PT35101
Amadora, Lisbon District, 2720-276, Portugal
Site PT35104
Lisbon, Lisbon District, 1099-023, Portugal
Site PT35103
Coimbra, 3041-801, Portugal
Site PT35102
Lisbon, 1400-038, Portugal
Site RO40004
Floreşti, Cluj, 407280, Romania
Site RO40001
Craiova, Dolj, 200347, Romania
Site RO40010
Craiova, Dolj, 200385, Romania
Site RO40007
Ploieşti, Prahova, 100010, Romania
Site RO40008
Timișoara, Timiș County, 300210, Romania
Site RO40012
Bucharest, 031422, Romania
Site RO40006
Sibiu, 550245, Romania
Site RU70012
Arkhangelsk, Arkhangelskaya oblast, 163045, Russia
Site RU70017
Ufa, Bashkortostan Republic, 450054, Russia
Site RU70009
Magnitogorsk, Chelyabinsk Oblast, 455001, Russia
Site RU70016
Nal'chik, Kabardino-Balkarskaya Respublika, 360000, Russia
Site RU70008
Pyatigorsk, Stavropol Kray, 357502, Russia
Site RU70001
Saint Petersburg, 197022, Russia
Site SG65001
Singapore, Central Singapore, 188770, Singapore
Site SG65002
Singapore, Central Singapore, 308433, Singapore
Site KR82010
Busan Gwang'yeogsi, Busan Gwang'yeogsi, 48108, South Korea
Site KR82004
Suwon, Gyeonggi-do, 16499, South Korea
Site KR82016
Suwon, Gyeonggido [Kyonggi-do], 16427, South Korea
Site KR82017
Bundang, Gyeonggido, 13620, South Korea
Site KR82009
Jinju, Gyeongsangnam-do, 660-702, South Korea
Site KR82003
Jeonju, Jeonrabugdo[Chollabuk-do], 54907, South Korea
Site KR82005
Cheongiu, North Chungcheong, 28644, South Korea
Site KR82002
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 028-481, South Korea
Site KR82001
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 05505, South Korea
Site KR82013
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 135-720, South Korea
Site KR82007
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 139-706, South Korea
Site KR82008
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 152-703, South Korea
Site KR82006
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 156-707, South Korea
Site KR82015
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 5368, South Korea
Site KR82014
Seoul, Seoul Teugbyeolsi, 130-701, South Korea
Site KR82011
Ulsan, Ulsan Gwang'yeogsi, 682-714, South Korea
Site ES34003
Barcelona, Catalonia, 08036, Spain
Site ES34008
San Sebastian, Guipuzcoa, Guipúzcoa, 20014, Spain
Site ES34010
Málaga, Málaga, 29010, Spain
Site ES34006
Madrid, 28046, Spain
Site ES34016
Madrid, 28050, Spain
Site ES34004
Ourense, 32004, Spain
Site ES34005
Seville, 41009, Spain
Site ES34015
Valencia, 46010, Spain
Site ES34017
Valencia, 46014, Spain
Site ES34002
Valencia, 46026, Spain
Site TW88605
Taichung, Taichung, 40447, Taiwan
Site TW88607
Taoyuan Hsien, Taoyuan, 33305, Taiwan
Site TW88606
Kaohsiung City, 83301, Taiwan
Site TW88603
Taichung, 40705, Taiwan
Site TW88601
Tainan, 70403, Taiwan
Site TW88604
Tainan, 736, Taiwan
Site TW88608
Taipei, 100, Taiwan
Site TW88609
Taipei, 11217, Taiwan
Site TW88611
Taipei, 11490, Taiwan
Site TH66011
Chom Thong, Chiang Mai, 50200, Thailand
Site TH66001
Bangkok, Krung Thep Maha Nakhon [Bangkok], 10330, Thailand
Site TH66012
Bangkok, Krung Thep Maha Nakhon [Bangkok], 10400, Thailand
Site TH66002
Chiang Rai, 57000, Thailand
Site TH66004
Khon Kaen, 40002, Thailand
Site TH66006
Songkhla, 90110, Thailand
Site UA38006
Chernivtsi, Chernivtsi Oblast, 58013, Ukraine
Site UA38001
Dnipropetrovsk, Dnipropetrovsk Oblast, 49102, Ukraine
Site UA38005
Kryvyi Rih, Dnipropetrovsk Oblast, 50048, Ukraine
Site UA38008
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76000, Ukraine
Site UA38004
Lviv, Lviv Oblast, 79031, Ukraine
Site UA38007
Lutsk, Volyn Oblast, 43018, Ukraine
Site UA38009
Uzhhorod, Zakarpattia Oblast, 88000, Ukraine
Site UA38003
Uzhhorod, Zakarpattia Oblast, 88014, Ukraine
Site GB44002
Middlesex, Hertfordshire, HA6 2RN, United Kingdom
Site GB44001
Liverpool, Wirral, CH63 4JY, United Kingdom
Site GB44003
Sheffield, S10 2SJ, United Kingdom
Related Publications (1)
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.
PMID: 31070709DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Medical Director
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Astellas Pharma Global Development, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2015
First Posted
October 27, 2015
Study Start
February 11, 2016
Primary Completion
December 21, 2017
Study Completion
December 21, 2017
Last Updated
December 10, 2024
Results First Posted
February 12, 2019
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.