AzTrials
AzTrials

Non-small Cell Lung Cancer (NSCLC)Phase 3SOLARNCT02588261

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

A Phase 3 study testing naquotinib mesilate, Erlotinib and Gefitinib in people with Non-small Cell Lung Cancer (NSCLC), run by Astellas Pharma Global Development, Inc. at 167 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
naquotinib mesilate, Erlotinib and Gefitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
530 participants
Where
167 sitesin 23 countries
Study dates
11 Feb 2016to 21 Dec 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

167 sites in 23 countries.

167 sites in 23 countries

United States25 sites

  • Site US10045

    Albuquerque, New Mexico, 87106

  • Site US10050

    Atlanta, Georgia, 30342

  • Site US10013

    Aventura, Florida, 33180

  • Site US10042

    Baton Rouge, Louisiana, 70809

  • Site US10021

    Bethlehem, Pennsylvania, 18015

  • Site US10029

    Beverly Hills, California, 90211

  • Site US10034

    Boston, Massachusetts, 02111

  • Site US10025

    Fountain Valley, California, 90806

  • Site US10047

    Glenwood Springs, Colorado, 81601

  • Site US10036

    La Jolla, California, 92093

  • Site US10011

    Lacey, Washington, 98503

  • Site US10051

    Loma Linda, California, 92350

  • Site US10033

    Los Angeles, California, 90033

  • Site US10046

    Milwaukee, Wisconsin, 53226

  • Site US10030

    Minneapolis, Minnesota, 55455

  • Site US10012

    Mount Kisco, New York, 10549

  • Site US10009

    Nashville, Tennessee, 37203

  • Site US10023

    Nashville, Tennessee, 37232

  • Site US10031

    Oxnard, California, 93030

  • Site US10052

    Redondo Beach, California, 90277

  • Site US10027

    Rochester, Minnesota, 55905

  • Site US10003

    Santa Monica, California, 90404

  • Site US10037

    Scarborough, Maine, 04074

  • Site US10048

    St. Petersburg, Florida, 33705

  • Site US10018

    Whittier, California, 90603

Other trials in United States

Japan21 sites

  • Site JP81021

    Hirakata, Ôsaka [Osaka], 573-1191

  • Site JP81013

    Hiroshima, Hirosima [Hiroshima], 730-8518

  • Site JP81015

    Kanazawa, Isikawa [Ishikawa], 920-8530

  • Site JP81024

    Kobe, Hyōgo, 650-0047

  • Site JP81016

    Kurashiki, Okayama-ken, 710-8602

  • Site JP81008

    Kurume, Hukuoka, 830-0011

  • Site JP81018

    Matsuyama, Ehime, 791-0280

  • Site JP81005

    Miyakojima-ku, Osaka, 534-0021

  • Site JP81022

    Niigata, 951-8122

  • Site JP81006

    Okayama, 700-8558

  • Site JP81002

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

  • Site JP81017

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

  • Site JP81020

    Osakasayama-shi, Osaka, 569-8511

  • Site JP81014

    Sapporo, Hokkaidô, 003-0804

  • Site JP81012

    Sendai, Miyagi, 980-0873

  • Site JP81019

    Sunto-gun, Shizuoka, 411-8777

  • Site JP81001

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

  • Site JP81004

    Tokyo, Tôkyô [Tokyo], 135-8550

  • Site JP81023

    Wakayama, 641-8510

  • Site JP81010

    Yokohama, Kanagawa, 236-0051

  • Site JP81025

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

South Korea16 sites

  • Site KR82017

    Bundang, Gyeonggido, 13620

  • Site KR82010

    Busan Gwang'yeogsi, Busan Gwang'yeogsi, 48108

  • Site KR82005

    Cheongiu, North Chungcheong, 28644

  • Site KR82003

    Jeonju, Jeonrabugdo[Chollabuk-do], 54907

  • Site KR82009

    Jinju, Gyeongsangnam-do, 660-702

  • Site KR82002

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 028-481

  • Site KR82001

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 05505

  • Site KR82013

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 135-720

  • Site KR82007

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 139-706

  • Site KR82008

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 152-703

  • Site KR82006

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 156-707

  • Site KR82015

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 5368

  • Site KR82014

    Seoul, Seoul Teugbyeolsi, 130-701

  • Site KR82004

    Suwon, Gyeonggi-do, 16499

  • Site KR82016

    Suwon, Gyeonggido [Kyonggi-do], 16427

  • Site KR82011

    Ulsan, Ulsan Gwang'yeogsi, 682-714

Other trials in South Korea

Italy10 sites

  • Site IT39011

    Aviano, Pordenone, 33081

  • Site IT39003

    Bergamo, 24127

  • Site IT39015

    Brescia, 25123

  • Site IT39002

    Cremona, 26100

  • Site IT39013

    Lucca, 55100

  • Site IT39014

    Milan, 20142

  • Site IT39004

    Monza, Lombardy, 20052

  • Site IT39012

    Piacenza, 29100

  • Site IT39008

    Roma, 00128

  • Site IT39009

    Rozzano, Lombardy, 20089

Other trials in Italy

Spain10 sites

  • Site ES34003

    Barcelona, Catalonia, 08036

  • Site ES34006

    Madrid, 28046

  • Site ES34016

    Madrid, 28050

  • Site ES34010

    Málaga, Málaga, 29010

  • Site ES34004

    Ourense, 32004

  • Site ES34008

    San Sebastian, Guipuzcoa, Guipúzcoa, 20014

  • Site ES34005

    Seville, 41009

  • Site ES34015

    Valencia, 46010

  • Site ES34017

    Valencia, 46014

  • Site ES34002

    Valencia, 46026

Other trials in Spain

Taiwan9 sites

  • Site TW88606

    Kaohsiung City, 83301

  • Site TW88605

    Taichung, Taichung, 40447

  • Site TW88603

    Taichung, 40705

  • Site TW88601

    Tainan, 70403

  • Site TW88604

    Tainan, 736

  • Site TW88608

    Taipei, 100

  • Site TW88609

    Taipei, 11217

  • Site TW88611

    Taipei, 11490

  • Site TW88607

    Taoyuan Hsien, Taoyuan, 33305

Other trials in Taiwan

France8 sites

  • Site FR33012

    Bayonne, Pyrénées-Atlantiques, 64100

  • Site FR33003

    Créteil, Ilej-de-France, 94010

  • Site FR33006

    Grenoble, Isère, 38043

  • Site FR33010

    Pessac, Gironde, 33604

  • Site FR33007

    Pierre-Bénite, Rhône, 69310

  • Site FR33009

    Saint Priest En Jarez, Pays de la Loire Region, 42270

  • Site FR33011

    Suresnes, Hauts-de-Seine, 92150

  • Site FR33004

    Tours, Indre-et-Loire, 37044

Other trials in France

Ukraine8 sites

  • Site UA38006

    Chernivtsi, Chernivtsi Oblast, 58013

  • Site UA38001

    Dnipropetrovsk, Dnipropetrovsk Oblast, 49102

  • Site UA38008

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76000

  • Site UA38005

    Kryvyi Rih, Dnipropetrovsk Oblast, 50048

  • Site UA38007

    Lutsk, Volyn Oblast, 43018

  • Site UA38004

    Lviv, Lviv Oblast, 79031

  • Site UA38009

    Uzhhorod, Zakarpattia Oblast, 88000

  • Site UA38003

    Uzhhorod, Zakarpattia Oblast, 88014

Other trials in Ukraine

Romania7 sites

  • Site RO40012

    Bucharest, 031422

  • Site RO40001

    Craiova, Dolj, 200347

  • Site RO40010

    Craiova, Dolj, 200385

  • Site RO40004

    Floreşti, Cluj, 407280

  • Site RO40007

    Ploieşti, Prahova, 100010

  • Site RO40006

    Sibiu, 550245

  • Site RO40008

    Timișoara, Timiș County, 300210

Other trials in Romania

Australia6 sites

  • Site AU61005

    Adelaide, South Australia, 5000

  • Site AU61008

    East Melbourne, Victoria, 3002

  • Site AU61002

    Fitzroy, Victoria, 3065

  • Site AU61004

    Footscray, Victoria, 3011

  • Site AU61003

    Randwick, New South Wales, 2031

  • Site AU61007

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany6 sites

  • Site DE49004

    Cologne, North Rhine-Westphalia, 51109

  • Site DE49008

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Site DE49003

    Gauting, Bavaria, 82131

  • Site DE49005

    Karlsruhe, Baden-Wurttemberg, 76137

  • Site DE49007

    Kassel, Hesse, 34125

  • Site DE49006

    Würzburg, Bavaria, 97080

Other trials in Germany

Hungary6 sites

  • Site HU36007

    Budapest, 1121

  • Site HU36001

    Budapest, 1125

  • Site HU36004

    Farkasgyepű, Veszprém megye, 8582

  • Site HU36002

    Székesfehérvár, Fejér, H 8000

  • Site HU36006

    Szombathely, Vas County, H 9700

  • Site HU36003

    Tatabánya, Tatabánya, H-2800

Other trials in Hungary

Russia6 sites

  • Site RU70012

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Site RU70009

    Magnitogorsk, Chelyabinsk Oblast, 455001

  • Site RU70016

    Nal'chik, Kabardino-Balkarskaya Respublika, 360000

  • Site RU70008

    Pyatigorsk, Stavropol Kray, 357502

  • Site RU70001

    Saint Petersburg, 197022

  • Site RU70017

    Ufa, Bashkortostan Republic, 450054

Other trials in Russia

Thailand6 sites

  • Site TH66001

    Bangkok, Krung Thep Maha Nakhon [Bangkok], 10330

  • Site TH66012

    Bangkok, Krung Thep Maha Nakhon [Bangkok], 10400

  • Site TH66002

    Chiang Rai, 57000

  • Site TH66011

    Chom Thong, Chiang Mai, 50200

  • Site TH66004

    Khon Kaen, 40002

  • Site TH66006

    Songkhla, 90110

Other trials in Thailand

Portugal4 sites

  • Site PT35101

    Amadora, Lisbon District, 2720-276

  • Site PT35103

    Coimbra, 3041-801

  • Site PT35104

    Lisbon, Lisbon District, 1099-023

  • Site PT35102

    Lisbon, 1400-038

Other trials in Portugal

Chile3 sites

  • Site CL56001

    Santiago, Región Metropolitana de Santia, 8380455

  • Site CL56002

    Viña del Mar, Valparaiso, 2520612

  • Site CL56007

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Malaysia3 sites

  • Site MY60002

    George Town, Pulau Pinang, 10450

  • Site MY60001

    Kuantan Pahang, Pahang, 25100

  • Site MY60004

    Kuching, Sarawak, 93586

Other trials in Malaysia

Peru3 sites

  • Site PE51001

    Cercado de Lima, Arequipa, 04001

  • Site PE51008

    Miraflores, Lima region, L18

  • Site PE51004

    San Isidro, Lima region, 1501

Other trials in Peru

United Kingdom3 sites

  • Site GB44001

    Liverpool, Wirral, CH63 4JY

  • Site GB44002

    Middlesex, Hertfordshire, HA6 2RN

  • Site GB44003

    Sheffield, S10 2SJ

Other trials in United Kingdom

Canada2 sites

  • Site CA15002

    Montreal, Quebec, H49 1C5

  • Site CA15006

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Netherlands2 sites

  • Site NL31006

    Alkmaar, North Holland, 1815 JD

  • Site NL31001

    Arnhem, Gelderland, 6815 AD

Other trials in Netherlands

Singapore2 sites

  • Site SG65001

    Singapore, Central Singapore, 188770

  • Site SG65002

    Singapore, Central Singapore, 308433

Other trials in Singapore

Belgium1 site

  • Site BE32002

    Ghent, West-Vlaanderen, 9000

Other trials in Belgium

About this study

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

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.

Being tested
naquotinib mesilate, Erlotinib, Gefitinib
Keywords
erlotinib, EGFR mutation, naquotinib, Non-small cell lung cancer (NSCLC), ASP8273, gefitinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • naquotinib mesilateDrug

    Also called ASP8273

    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.

  • ErlotinibDrug

    Also called Tarceva, OSI-774

    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.

  • GefitinibDrug

    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.

Study groups in NCT02588261
Study groupRoleWhat they receive
ASP8273ExperimentalParticipants 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).
Receives: Drug: naquotinib mesilate
erlotinib or gefitinibActive 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).
Receives: Drug: Erlotinib; Drug: Gefitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)

Secondary outcomes (10)

  1. Percentage of Deaths

    All events of death after the first study drug administration were included.

    Measured: From date of randomization up to data cut-off date 21 Dec 2017 (approximately 22 months)

  2. Percentage of Participants With Objective Response (OR)

    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.

    Measured: From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)

  3. PFS as Assessed by the Investigator

    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.

    Measured: From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)

  4. Percentage of Participants With Disease Control

    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.

    Measured: From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)

  5. Duration of Response (DOR)

    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.

    Measured: From date of first response up to data cut-off date 09 May 2017 (approximately 15 months)

  6. Number of Participants With Adverse Events (AEs)

    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.

    Measured: 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

  7. Functional Assessment of Cancer Therapy - EGFR Inhibitors Subscale (FACT-EGFRI-18) Questionnaire

    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).

    Measured: Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)

  8. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC-QLQ-LC13)

    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.

    Measured: Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)

  9. European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)

    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.

    Measured: Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)

  10. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    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).

    Measured: Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2015 (estimated)
  2. Study start11 Feb 2016
  3. Primary completion21 Dec 2017
  4. Study completion21 Dec 2017

Why it stopped: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02588261
Sponsor's protocol ID
8273-CL-0302
Other IDs
2015-002894-39, 2015
Acronym
SOLAR
Status last verified
Nov 2024
First submitted
26 Oct 2015
Last updated
10 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/.

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.

    PubMed 31070709

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing naquotinib mesilate, Erlotinib and Gefitinib in people with Non-small Cell Lung Cancer (NSCLC), run by Astellas Pharma Global Development, Inc. at 167 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Japan, South Korea, Italy, Spain and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02588261, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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