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An Efficacy Study Comparing Brigatinib Versus Alectinib in Advanced Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small-Cell Lung Cancer (NSCLC) Participants Who Have Progressed on Crizotinib (ALTA-3) - Brigatinib-3001

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC.
- 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).
- 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).
- Treatment with crizotinib for at least 4 weeks before progression.
- Have had no other ALK inhibitor other than crizotinib.
- 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).
- Have at least 1 measurable (that is, target) lesion per RECIST v1.1.
- 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).
- 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.
Suitable venous access for study-required blood sampling (that is, including pharmacokinetic [PK] and laboratory safety tests).

Criteri di esclusione: 

- Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L).
- Had received crizotinib within 7 days of randomization.
- Have a history or presence at baseline of pulmonary interstitial disease, drug related pneumonitis, or radiation pneumonitis.
- Have uncontrolled hypertension. Participants with hypertension should be under treatment for control of blood pressure upon study entry.
- 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.
- Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before randomization.
- Had received chemotherapy or radiation therapy within 14 days of randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.
- Had received antineoplastic monoclonal antibodies within 30 days of randomization.
- Had major surgery within 30 days of randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.
- 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.
- Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
- 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.
- Had cerebrovascular accident or transient ischemic attack within 6 months before first dose of study drug.
- Have malabsorption syndrome or other gastrointestinal illness or condition that could affect oral absorption of the study drug.
- Have an ongoing or active infection, including but not limited to, the requirement for intravenous antibiotics.
- Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history.
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
- Have a known or suspected hypersensitivity to brigatinib or alectinib or their excipients.
- Life-threatening illness unrelated to cancer.

Schema di trattamento: 

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.

Alectinib 600 mg, capsules, orally twice daily until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.

Trattamento sperimentale: 

Brigatinib

Trattamento di controllo: 

Alectinib

Obiettivi primari dello studio: 

The purpose of this study is to compare the efficacy of brigatinib versus alectinib in participants with ALK+ locally advanced or metastatic NSCLC who have progressed on crizotinib as evidenced by progression-free survival (PFS) as assessed by response evaluation criteria in solid tumors (RECIST) v1.1.

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

 

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

 

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN

 

Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA
Ospedale Santa Maria delle Croci

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-001957-29

Data di inserimento: 01.07.2020

Promotore

Takeda (Ariad Pharmaceuticals)

CRO

na

Principal Investigator ITALIA

Riferimento: Dr.ssa non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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