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JOURNAL ONKOLOGIE – STUDIE

TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Rekrutierend

NCT-Nummer:
NCT04129502

Studienbeginn:
Januar 2020

Letztes Update:
29.01.2021

Wirkstoff:
TAK-788, Pemetrexed, Cisplatin, Carboplatin

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Millennium Pharmaceuticals, Inc.

Collaborator:
-

Studienleiter

Medical Director
Study Director
Millennium Pharmaceuticals, Inc.

Kontakt

Studienlocations
(3 von 168)

Klinik Schillerhohe
70839 Gerlingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
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Phone: +4971562037658
E-Mail: evelin.sandner@klinik-schillerhoehe.de
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Thoraxklinik-Heidelberg gGmbH
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
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Site Contact
Phone: +4962213961301
E-Mail: michael.thomas@med.uni-heidelberg.de
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Malteser Krankenhaus St. Franziskus-Hospital
24939 Flensburg
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
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Site Contact
Phone: +494618162512
E-Mail: nadezda.basara@malteser.org
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LungenClinic Grosshansdorf GmbH
22927 Grosshansdorf
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
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Site Contact
Phone: +4941026012101
E-Mail: m.reck@lungenclinic.de
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Levine Cancer Institute (Main Campus)
28204 Charlotte
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: 980-442-2000
E-Mail: kathryn.mileham@carolinashealthcare.org
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The First Affiliated Hospital, College of Medicine, Zhejiang University
310003 Hangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +86057187236876
E-Mail: drzjy@163.com
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Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
47014 Meldola
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +390543739100
E-Mail: angelo.delmonte@irst.emr.it
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Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
95122 Catania
ItalyRekrutierend» Google-Maps
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Site Contact
Phone: +390953751496
E-Mail: hsotoparra.ctu@gmail.com
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The Catholic University of Korea, Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +82222587563
E-Mail: oncologykang@naver.com
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Centro Hospitalar do Porto Hospital de Santo Antonio
4520-211 Santa Maria Da Feira
PortugalRekrutierend» Google-Maps
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Phone: +351222077500
E-Mail: amfaraujo@netcabo.pt
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Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente
1769-001 Lisboa
PortugalRekrutierend» Google-Maps
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Phone: 351217 548 085
E-Mail: encarnacaoteixeira@gmail.com
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Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
4200-072 Porto
PortugalRekrutierend» Google-Maps
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Phone: +3512250840007743
E-Mail: Ana.fernandes.rodrigues@ipoporto.min-saude.pt
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GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
197758 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
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Phone: +79119192688
E-Mail: moiseenkofv@gmail.com
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Scientific Research Institute of Oncology n.a. N.N. Petrov
197758 St. Petersburg
Russian FederationRekrutierend» Google-Maps
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Site Contact
Phone: +78125968538
E-Mail: onco.lev@gmail.com
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Hospital Universitario Puerta de Hierro - Majadahonda
28222 Majadahonda
SpainRekrutierend» Google-Maps
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Phone: 34911917147
E-Mail: mprovencio.ensayosclinicos@gmail.com
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Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
622 Dalin
TaiwanRekrutierend» Google-Maps
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Phone: +88652648000x5007
E-Mail: CHESTLAI@tzuchi.com.tw; albertla@ms8.hinet.net
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Baskent University Medical Faculty Adana Practice and Research Center
01120 Yuregir
TurkeyRekrutierend» Google-Maps
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Phone: +905053067506
E-Mail: ozyilkano@hotmail.com
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Saguk Bankanligi Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi
34772 Kadikoy
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +905063509061
E-Mail: mgumus@superonline.com
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Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS
49102 Dnipropetrovsk
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +380562585372
E-Mail: oncology@dsma.dp.ua
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Municipal Non-profit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC
76018 Ivano-Frankivsk
UkraineRekrutierend» Google-Maps
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Site Contact
Phone: 380502094000
E-Mail: anna.nivska@gmail.com
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Private Enterprise Private Manufacturing Company Acinus
25006 Kropyvnytskyi
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: 380503219357
E-Mail: doctor.ursol25006@gmail.com
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The Christie NHS Foundation Trust - PPDS
M20 4GJ Manchester
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +4401614463745
E-Mail: Raffaele.califano@christie.nhs.uk
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Alle anzeigen

Studien-Informationen

Detailed Description:

The drug being tested in this study is called TAK-788. TAK-788 is being tested to evaluate

the efficacy as a first line treatment compare with platinum-based chemotherapy in the

participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose

tumors harbor EGFR exon 20 insertion mutations.

The study will enroll approximately 318 patients. Participants will be randomly assigned to

one of the two treatment groups-

- TAK-788 group (Arm A)

- Platinum-based chemotherapy group (Arm B)

The participants will be administered with TAK-788 orally in arm A and Pemetrexed/Cisplatin

or Pemetrexed/Carboplatin intravenously (IV) in arm B until the participants experience

progressive disease (PD) as assessed by blinded independent review committee (IRC),

intolerable toxicity or another discontinuation criteria. Participants in the chemotherapy

group may cross over to treatment with TAK-788 after IRC-assessed PD is documented.

Randomized treatment with TAK-788 or platinum-based chemotherapy may be continued after PD,

at the discretion of the investigator and with the sponsor's approval, if there is still

evidence of clinical benefit.

This multi-center trial will be conducted in United States, Europe, and Asia. The overall

time to participate in this study is until 3 years after the last participant is randomized.

Participants will make multiple visits to the clinic and will be followed for survival,

subsequent anticancer therapy, subsequent disease assessment outcome until disease

progression on a subsequent anticancer therapy, and participant-reported health status

(EQ-5D-5L) for 3 years after the last participant is randomized in the study and 30 days

after the last dose of study drug for safety follow-up.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically confirmed nonsquamous cell locally advanced not

suitable for definitive therapy, recurrent, or metastatic (Stage IV) non-small cell

lung cancer (NSCLC)

- Documented epithelial growth factor receptor (EGFR) in-frame exon 20 insertion

mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified

(United States [US] sites) or an accredited (outside of the US) local laboratory The

EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR

or HER2 mutations except EGFR mutations for which there are approved anti-EGFR TKIs

(ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino

acid)

- Adequate tumor tissue available, either from primary or metastatic sites, for central

laboratory confirmation of EGFR exon 20 insertion mutation

- At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST)

version 1.1

- Life expectancy ≥3 months

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

- Received prior systemic treatment for locally advanced or metastatic disease

- Received radiotherapy ≤14 days before randomization or has not recovered from

radiotherapy-related toxicities

- Received a moderate or strong cytochrome P-450 (CYP)3A inhibitor or moderate or strong

CYP3A inducer within 10 days before randomization

- Have been diagnosed with another primary malignancy other than NSCLC

- Have current spinal cord compression or leptomeningeal disease

- Have uncontrolled hypertension. Participants with hypertension should be under

treatment on study entry to control blood pressure

- Received a live vaccine within 4 weeks before randomization per Summary of product

characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Time Frame - Up to approximately 40 months after the first participant is randomized):
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for PD according to RECIST version 1.1 are met or death, whichever occurs first.



Secondary outcome:

1. Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1 (Time Frame - Up to approximately 40 months after the first participant is randomized):
Confirmed ORR is defined as the proportion of participants who are confirmed to have achieved complete response (CR) or partial response (PR). Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.

2. Overall Survival (OS) (Time Frame - Up to approximately 40 months after the first participant is randomized):
OS is defined as the interval from the date of randomization until death.

3. Progression Free Survival (PFS) as Assessed by the Investigator (Time Frame - Up to approximately 40 months after the first participant is randomized):
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST version 1.1 are met or death, whichever occurs first.

4. Confirmed Objective Response Rate (ORR) as Assessed by the Investigator (Time Frame - Up to approximately 40 months after the first participant is randomized):
Confirmed ORR is defined as the proportion of participants who are confirmed to have achieved CR or PR. Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.

5. Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator (Time Frame - Up to approximately 40 months after the first participant is randomized):
Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented.

6. Time to Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator (Time Frame - Up to approximately 40 months after the first participant is randomized):
Time to response is defined as the time interval from the date of randomization until the initial observation of CR or PR.

7. Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator (Time Frame - Up to approximately 40 months after the first participant is randomized):
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study drug.

8. Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 (Time Frame - Up to approximately 40 months after the first participant is randomized):
EORTC QLQ-C30 is a cancer-specific questionnaire which comprises of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores will be converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL (i.e., a low level of symptomatology/problems).

9. Participant-reported Symptoms as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13) (Time Frame - Up to approximately 40 months after the first participant is randomized):
EORTC QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Raw scores will be converted into scale scores ranging from 0 to 100. Higher scores represent a high level of symptomatology/problems.

Studien-Arme

  • Experimental: TAK-788 Group (Arm A)
    TAK-788 160 mg, capsules, orally, once daily until the participants experience progressive disease (PD) as assessed by blinded independent review committee (IRC), intolerable toxicity, or another discontinuation criteria.
  • Active Comparator: Platinum-based Chemotherapy Group (Arm B)
    Pemetrexed 500 mg/m^2 plus Cisplatin 75 mg/m^2, infusion, intravenously, once on Day 1 of 21-day cycle pemetrexed 500 mg/m^2 plus Carboplatin, infusion, intravenously, once at a dose calculated to produce area under curve (AUC) of 5 mg*min/mL on Day 1 of 21-day cycle until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. Pemetrexed/Cisplatin or pemetrexed/Carboplatin will be repeated every 3 weeks for 4 cycles, followed by maintenance treatment with pemetrexed 500 mg/m^2, on Day 1 of a 21-day cycle thereafter.

Geprüfte Regime

  • TAK-788 (AP32788):
    TAK-788 capsule
  • Pemetrexed (Alimta):
    Pemetrexed IV infusion
  • Cisplatin:
    Cisplatin IV infusion
  • Carboplatin:
    Carboplatin IV infusion

Quelle: ClinicalTrials.gov


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