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JOURNAL ONKOLOGIE – STUDIE
ALTA-3

A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT03596866

Studienbeginn:
April 2019

Letztes Update:
24.02.2021

Wirkstoff:
Brigatinib, Alectinib

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Takeda

Collaborator:
-

Studienleiter

Medical Director Clinical Science
Study Director
Takeda

Kontakt

Studienlocations
(3 von 113)

Lungenkrebszentrum des NCT Heidelberg; Thoraxklinik Heidelberg
Im Neuenheimer Feld 672
69126 Heidelberg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +4962213960
E-Mail: michael.thomas@med.uni-heidelberg.de
» Ansprechpartner anzeigen
New York Oncology Hematology - Albany Medical Center
12208 Albany
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: 518-262-6696
E-Mail: makenzi.evangelist@usoncology.com
» Ansprechpartner anzeigen
Centro Para la Atencion Integral del Paciente Oncologico
4000 San Miguel De Tucuman
ArgentinaRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +5403814305518
E-Mail: fpalazzo98@hotmail.com
» Ansprechpartner anzeigen
The First Affiliated Hospital of Guangzhou Medical University
510120 Guangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +8613802777270
E-Mail: drjianxing.he@gmail.com
» Ansprechpartner anzeigen
Affiliated Tumor Hospital of Harbin Medical University - The 3rd Affiliated Hospital of HMU
150081 Harbin
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +86 13633668886
E-Mail: chengongyan@163.com
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Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
31059 Toulouse Cedex 9
FranceRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +33567771818
E-Mail: mazieres.j@chu-toulouse.fr
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Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
83056 Toulon
FranceRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +33494145870
E-Mail: clarisse.audigier-valette@ch-toulon.fr
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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
47014 Meldola
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +39543739100
E-Mail: angelo.delmonte@irst.emr.it
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Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +39512142204
E-Mail: andrea.ardizzoni@aosp.bo.it
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The Catholic University of Korea St. Vincent's Hospital
16247 Suwon-si
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +82312497114
E-Mail: shimby@catholic.ac.kr
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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: +8225901081
E-Mail: oncologykang@naver.com
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Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucaresti
022328 Bucuresti
RomaniaRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +400212271001
E-Mail: auralexandru@yahoo.com
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State Institution of Healthcare Arkhangelsk Regional Clinical Oncology Dispensary
163045 Arkhangelsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +78182276501
E-Mail: sm_nechaev@mail.ru
» Ansprechpartner anzeigen
Saint Petersburg Clinical Scientific and Practical Center of Specialized Types of Medical Aid
197758 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +79214399506
E-Mail: moiseenkofv@gmail.com
» Ansprechpartner anzeigen
State Budget Institution National Medical Research Center of Radiology of the Ministry of Heal
125284 Moscow
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +79262110975
E-Mail: fedenko@eesg.ru
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Omsk Regional Clinical Oncologic Dispensary
644013 Omsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +7 9136 882 778
E-Mail: mvdvorkin@gmail.com
» Ansprechpartner anzeigen
Saint Petersburg State Healthcare Institution Municipal Clinical Oncology Dispensary
197758 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +79111019156
E-Mail: spboncologycenter@yandex.ru
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to

benefit people with ALK+ NSCLC.

The comparator drug is called alectinib. Alectinib has been demonstrated to benefit people

with ALK+ NSCLC. Both drugs belong to a class of drugs called anaplastic lymphoma kinase

(ALK) inhibitors. Both drugs are taken by mouth. Both drugs are approved by the United States

Food and Drug Administration (US FDA).

The study will enroll approximately 246 participants. Participants will be randomly assigned

(by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups:

- Brigatinib

- Alectinib

All participants will be asked to take brigatinib or alectinib at the same time each day

throughout the study.

This multi-center trial will be conducted in the United States, Argentina, Austria, Canada,

Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia,

South Korea, Spain, Sweden, Taiwan, and Thailand. The overall time to participate in this

study is 5 years. Participants will make multiple visits to the clinic, and 30 days after

last dose of study drug for a follow-up assessment.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

2. Have histologically or cytologically confirmed stage IIIB (locally advanced or

recurrent) or stage IV NSCLC.

3. Must meet one of the following criteria:

- Have documentation of ALK rearrangement by a positive result from the Vysis ALK

Break-Apart fluorescence in situ hybridization (FISH) Probe Kit or the Ventana

ALK (D5F3) CDx Assay or Foundation Medicine's FoundationOne CDx.

- Have documented ALK rearrangement by a different test and be able to provide

tumor sample to the central laboratory. (Note: central laboratory ALK

rearrangement testing results are not required to be obtained before

randomization).

4. Had PD while on crizotinib, as assessed by the investigator or treating physician.

(Note: crizotinib does not need to be the last therapy a participant received. The

participant may have received chemotherapy as his/her last therapy).

5. Treatment with crizotinib for at least 4 weeks before progression.

6. Have had no other ALK inhibitor other than crizotinib.

7. Have had no more than 2 prior regimens of systemic anticancer therapy (other than

crizotinib) in the locally advanced or metastatic setting. Note: a systemic anticancer

therapy regimen will be counted if it is administered for at least 1 complete cycle. A

new anticancer agent used as maintenance therapy will be counted as a new regimen.

Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen

if disease progression/recurrence occurred within 12 months upon completion of this

neoadjuvant or adjuvant therapy. (Systemic therapy followed by maintenance therapy

will be considered as one regimen if the maintenance therapy consists of a drug or

drugs that were used in the regimen that immediately preceded maintenance).

8. Have at least 1 measurable (that is, target) lesion per RECIST v1.1.

9. Have recovered from toxicities related to prior anticancer therapy to national cancer

institute common terminology criteria for adverse events (NCI CTCAE) v4.03 grade less

than or equal to (<=)1. (Note: treatment-related alopecia or peripheral neuropathy

that are grade greater than (>) 1 are allowed, if deemed irreversible).

10. Have adequate organ function, as determined by:

- Total bilirubin <=1.5 times the upper limit of normal (ULN).

- Estimated glomerular filtration rate greater than equal to (>=) 30 milliliter per

minute (mL/min)/1.73 square meter [m^2], using the modification of diet in renal

disease equation.

- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <=2.5*ULN;

<=5*ULN is acceptable if liver metastases are present.

- Serum lipase <=1.5*ULN.

- Platelet count >=75*10^9 per liter [/L].

- Hemoglobin >=9 gram per deciliter (g/dL).

- Absolute neutrophil count >=1.5*10^9 / L.

11. Suitable venous access for study-required blood sampling (that is, including

pharmacokinetic [PK] and laboratory safety tests).

Exclusion Criteria:

1. Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L).

2. Had received crizotinib within 7 days before randomization.

3. Have a history or presence at baseline of pulmonary interstitial disease, drug related

pneumonitis, or radiation pneumonitis.

4. Have uncontrolled hypertension. Participants with hypertension should be under

treatment for control of blood pressure upon study entry.

5. Had received systemic treatment with strong cytochrome P-450 (CYP) 3A inhibitors,

moderate CYP3A inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14

days before randomization.

6. Treatment with any investigational systemic anticancer agents within 14 days or 5

half-lives, whichever is longer, before randomization.

7. Have been diagnosed with another primary malignancy other than NSCLC, except for

adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively

treated nonmetastatic prostate cancer; or patients with another primary malignancy who

are definitively relapse-free with at least 3 years elapsed since the diagnosis of the

other primary malignancy.

8. Had received chemotherapy or radiation therapy within 14 days before randomization

except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.

9. Had received antineoplastic monoclonal antibodies within 30 days of randomization.

10. Had major surgery within 30 days of randomization. Minor surgical procedures, such as

catheter placement or minimally invasive biopsies, are allowed.

11. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening

(participants with asymptomatic brain metastases or participants who have stable

symptoms and did not require an increased dose of corticosteroids to control symptoms

within 7 days before randomization will be enrolled). Note: If a participant has

worsening neurological symptoms or signs due to CNS metastasis, the participant needs

to complete local therapy and be neurologically stable (with no requirement for an

increasing dose of corticosteroids or use of anticonvulsants) for 7 days before

randomization.

12. Have current spinal cord compression (symptomatic or asymptomatic and detected by

radiographic imaging). Participants with leptomeningeal disease and without cord

compression are allowed.

13. Have significant, uncontrolled, or active cardiovascular disease, specifically

including, but not restricted to the following:

- Myocardial infarction within 6 months before randomization.

- Unstable angina within 6 months before randomization.

- New York Heart Association Class III or IV heart failure within 6 months before

randomization.

- History of clinically significant atrial arrhythmia (including clinically

significant bradyarrhythmia), as determined by the treating physician.

- Any history of clinically significant ventricular arrhythmia.

14. Had cerebrovascular accident or transient ischemic attack within 6 months before first

dose of study drug.

15. Have malabsorption syndrome or other gastrointestinal illness or condition that could

affect oral absorption of the study drug.

16. Have an ongoing or active infection, including but not limited to, the requirement for

intravenous antibiotics.

17. Have a known history of human immunodeficiency virus (HIV) infection. Testing is not

required in the absence of history.

18. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C

infection. Testing is not required in the absence of history.

19. Any serious medical condition or psychiatric illness that could, in the investigator's

opinion, potentially compromise patient safety or interfere with the completion of

treatment according to this protocol.

20. Have a known or suspected hypersensitivity to brigatinib or alectinib or their

excipients.

21. Life-threatening illness unrelated to cancer.

22. Female patients who are lactating and breastfeeding.

23. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.

Studien-Rationale

Primary outcome:

1. PFS as Assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1 (Time Frame - Up to 5 years):
PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by BIRC, or death due to any cause, whichever occurs first, in the full analysis set. PFS will be censored for participants without documented disease progression or death at the last valid tumor response assessment.



Secondary outcome:

1. Overall Survival (OS) (Time Frame - Up to 5 years):
OS is defined as the time interval from the date of randomization until death due to any cause in the full analysis set. It will be censored on the date of last contact for those participants who are alive.

2. PFS as Assessed by Investigator per RECIST v1.1 (Time Frame - Up to 5 years):
PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by investigator, or death due to any cause, whichever occurs first, in the full analysis set. PFS will be censored for participants without documented disease progression or death at the last valid tumor response assessment.

3. Objective Response Rate (ORR) as Assessed by Investigator and BIRC per RECIST v1.1 (Time Frame - Up to 5 years):
ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), using RECIST v1.1 after the initiation of study treatment.

4. Duration of Response (DOR) as Assessed by Investigator and BIRC (Time Frame - Up to 5 years):
DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the progressive disease (PD) is objectively documented or death, as assessed by the investigator and BIRC, using RECIST v1.1.

5. Time to Response as Assessed by Investigator and BIRC (Time Frame - Up to 5 years):
Time to response is defined as the time interval from randomization until the initial observation of CR or PR, as assessed by the investigator and BIRC, using RECIST v1.1. Time to response will be summarized using descriptive statistics in participants with confirmed objective response.

6. Intracranial Objective Response Rate (iORR) as Assessed by BIRC per Modified RECIST v1.1 (Time Frame - Up to 5 years):
iORR, as assessed by the BIRC, is defined as the percentage of the participants who have achieved CR or PR in the central nervous system (CNS) per a modification RECIST v1.1 after the initiation of study treatment in participants with CNS metastases at baseline.

7. Intracranial Duration of Response (iDOR) as Assessed by the BIRC per Modified RECIST v1.1 (Time Frame - Up to 5 years):
iDOR, as assessed by the BIRC per modified RECIST v1.1, is defined as the time interval from the time that the measurement criteria are first met for CR or PR in the CNS (whichever is first recorded) until the first date that the PD in the CNS is objectively documented or death.

8. Time to Intracranial Disease Progression (iPD) as Assessed by BIRC per Modified RECIST v1.1 (Time Frame - Up to 5 years):
Time to iPD, as assessed by the BIRC, is defined as the time interval from the date of randomization until the first date at which iPD is objectively documented via a modification of RECIST v1.1. Time to iPD will be censored for participants without documented iPD at the last valid intracranial tumor response assessment.

9. Health-Related Quality of Life (HRQOL) from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score (Time Frame - First dose of study drug up to 30 days after last dose (approximately 5 years)):
EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL.

10. HRQOL from EORTC QLQ- Lung Cancer (LC) 13 (Time Frame - First dose of study drug up to 30 days after last dose (approximately 5 years)):
HRQOL scores will be assessed with European Organization for Research and Treatment (EORTC), its lung cancer module QLQ-LC13. QLQ-LC13 contains 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. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.

Studien-Arme

  • Experimental: Brigatinib
    Brigatinib 90 milligram (mg), tablets, orally, once daily 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.
  • Active Comparator: Alectinib
    Alectinib 600 mg, capsules, orally twice daily until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.

Geprüfte Regime

  • Brigatinib (Alunbrig):
    Brigatinib Tablets.
  • Alectinib (Alecensa):
    Alectinib Capsules.

Quelle: ClinicalTrials.gov


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