JOURNAL ONKOLOGIE – STUDIE

Study of Lorlatinib In Participants With Anaplastic Lymphoma Kinase (ALK) -Positive NSCLC

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04362072

Studienbeginn:
September 2020

Letztes Update:
18.02.2021

Wirkstoff:
Lorlatinib

Indikation (Clinical Trials):
Lymphoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 4

Sponsor:
Pfizer

Collaborator:
-

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com» Kontaktdaten anzeigen

Studienlocations (3 von 30)

UCI Medical Center/Chao Family Comprehensive Cancer Center
92868 Orange
United StatesNoch nicht rekrutierend» Google-Maps

University Cancer & Blood Center, Llc
30607 Athens
United StatesNoch nicht rekrutierend» Google-Maps

Ospedale San Gerardo ASST Monza Centro Ricerca Fase 1
20900 Monza
ItalyNoch nicht rekrutierend» Google-Maps

IRCCS Ospedale San Raffaele
20132 Milano
ItalyNoch nicht rekrutierend» Google-Maps

Ospedale San Gerardo ASST Monza Oncologia Medica
20900 Monza
ItalyNoch nicht rekrutierend» Google-Maps

Centro Riferimento Oncologico di Aviano - IRCCS SOC Oncologia Medica e dei Tumori Immunocorrelati
33081 Aviano
ItalyRekrutierend» Google-Maps

AOU San Luigi Gonzaga
10043 Orbassano
ItalyNoch nicht rekrutierend» Google-Maps

Azienda Ospedaliera San Giuseppe Moscati
83100 Avellino
ItalyNoch nicht rekrutierend» Google-Maps

IRCCS Istituto Tumori "Giovanni Paolo II"
70124 Bari
ItalyNoch nicht rekrutierend» Google-Maps

Ms Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spolka Jawna
20-064 Lublin
PolandNoch nicht rekrutierend» Google-Maps

Elkardia Lubelskie Centrum Kardiologii
20-091 Lublin
PolandNoch nicht rekrutierend» Google-Maps

Centrum Medyczne Luxmed Sp. z o.o.
20-504 Lublin
PolandNoch nicht rekrutierend» Google-Maps

Centrum Medyczne EVOMED
70-382 Szczecin
PolandNoch nicht rekrutierend» Google-Maps

Dom Lekarski Centrum Medyczne Outlet Park
70-784 Szczecin
PolandNoch nicht rekrutierend» Google-Maps

Dom Lekarski S.A.
71-064 Szczecin
PolandNoch nicht rekrutierend» Google-Maps

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Tadeusza Sokolowskiego Pomorskiego UM
71-252 Szczecin
PolandNoch nicht rekrutierend» Google-Maps

Hospital Universitario Puerta de Hierro Majadahonda
28222 Majadahonda
SpainNoch nicht rekrutierend» Google-Maps

Hospital Teresa Herrera (C.H.U.A.C)
15006 A Coruña
SpainNoch nicht rekrutierend» Google-Maps

Hospital de la Santa Creu i Sant Pau
08025 Barcelona
SpainNoch nicht rekrutierend» Google-Maps

CETIR Centre Mèdic
08029 Barcelona
SpainNoch nicht rekrutierend» Google-Maps

Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps

Hospital de la Santa Creu i Sant Pau
08041 Barcelona
SpainNoch nicht rekrutierend» Google-Maps

ICO L'Hospitalet (Hospital Duran i Reynals)
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps

Hospital Universitario Ramon y Cajal
28034 Madrid
SpainNoch nicht rekrutierend» Google-Maps

Hospital Regional Universitario de Malaga
29010 Malaga
SpainNoch nicht rekrutierend» Google-Maps

Hospital Regional Universitario de Malaga (Hospital Civil)
29011 Malaga
SpainNoch nicht rekrutierend» Google-Maps

Clínica Radiológica Mario Gallegos
29016 Málaga
SpainNoch nicht rekrutierend» Google-Maps

Vithas
29016 Málaga
SpainNoch nicht rekrutierend» Google-Maps

Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainNoch nicht rekrutierend» Google-Maps

Cantonal Hospital Winterthur
8400 Winterthur
SwitzerlandNoch nicht rekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

A Phase 4 study to assess Overall and Intracranial Response Rate of single-agent lorlatinib

in participants with advanced ALK-positive NSCLC whose disease has progressed on alectinib or

ceritinib as the first ALK tyrosine kinase inhibitor (TKI)therapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants must have evidence of histologically or cytologically confirmed diagnosis

of metastatic NSCLC (Stage IV, American Joint Committee on Cancer [AJCC] v7.0) that

carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)

approved fluorescence in situ hybridization (FISH) assay (Abbott Molecular Inc) or by

Immunohistochemistry (IHC) (Ventana Inc).

- Disease Status Requirements: disease progression after alectinib or ceritinib as first

line therapy (the study will limit enrollment of participants with best response of

progression or indeterminate on prior alectinib to 8 participants). Participants may

have had prior chemotherapy, but only if before starting treatment with alectinib or

ceritinib.

- Tumor Requirements: All Participants must have at least one measurable target

extracranial lesion according to RECIST v1.1. Participants with asymptomatic CNS

metastases (including participants controlled with stable or decreasing steroid use

within the last 2 weeks prior to study entry) will be eligible. Participants who have

leptomeningeal disease (LM) or carcinomatous meningitis (CM) will be eligible if the

LM/CM is visualized on magnetic resonance imaging (MRI) or if documented baseline

cerebral spinal fluid (CSF) positive cytology is available.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

- Adequate bone marrow functioning, pancreatic function, renal function and liver

function

- Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade ≤1

except for adverse events (AEs) that in the investigator' judgment do not constitute a

safety risk for the participant.

- Systemic anti-cancer therapy with alectinib or ceritinib discontinued within a minimum

of 5 half-lives prior to first dose of lorlatinib on the study (unless clinically

meaningful tumor flare per discretion of the investigator, in which discussion with

the sponsor is warranted).

- Male participants are eligible to participate if they agree to use proper

contraception during the intervention period and for at least 98 days after the last

dose of study intervention

- Female participants are eligible to participate if they are not pregnant or

breastfeeding, and agree to use proper contraception during the intervention period

and for at least 35 days after the last dose of study intervention.

- Capable of giving signed informed consent and willingness and ability to comply with

the study scheduled visits and other procedures.

Exclusion criteria:

- Prior ALK TKI treatment or anti-cancer treatment other than first line alectinib or

ceritinib.

- Spinal cord compression unless the participant has good pain control attained through

therapy, and there is stabilization or recovery of neurological function for the 4

weeks prior to randomization.

- Gastrointestinal abnormalities, including inability to take oral medication;

requirement for intravenous alimentation; prior surgical procedures affecting

absorption including total gastric resection or lap band; active inflammatory

gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease;

treatment for active peptic ulcer disease in the past 6 months; malabsorption

syndromes.

- Active and clinically significant bacterial, fungal, or viral infection including

hepatitis B virus (HBV) or hepatitis C virus (HCV), known human immunodeficiency virus

(HIV), or acquired immunodeficiency syndrome (AIDS) related illness.

- Clinically significant vascular (both arterial and venous) and non-vascular cardiac

conditions, (active or within 3 months prior to enrollment)

- Participants presenting with abnormal Left Ventricular Ejection Fraction (LVEF) by

echocardiogram or Multi-Gated Acquisition Scan according to institutional lower

limits.

- Participants with predisposing characteristics for acute pancreatitis according to

investigator judgment

- History or known presence of interstitial fibrosis, interstitial lung disease,

pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative

bronchiolitis, and pulmonary fibrosis.

- Other severe acute or chronic medical or psychiatric condition, including recent

(within the past year) or active suicidal ideation or behavior, or laboratory

abnormality that may increase the risk associated with study participation or

investigational product administration or may interfere with the interpretation of

study results and, in the judgment of the investigator, would make the participant

inappropriate for entry into this study.

- Evidence of active malignancy (other than current NSCLC, non-melanoma skin cancer, in

situ cervical cancer, papillary thyroid cancer, ductal carcinoma in situ (DCIS) of the

breast or localized and presumed cured prostate cancer) within the last 3 years prior

to randomization.

- Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study

entry. Palliative radiation must have been completed at least 48 hours prior to study

entry. Stereotactic or small field brain irradiation must have completed at least 2

weeks prior to study entry. Whole brain radiation must have completed at least 4 weeks

prior to study entry.

- Prior irradiation to >25% of the bone marrow.

- Concurrent use of any of the following food or drugs within 12 days prior to the first

dose of lorlatinib: known strong CYP3A inducers, known strong CYP3A inhibitors, known

CYP3A substrates with narrow therapeutic index, known permeability glycoprotein (P-gp)

substrates with a narrow therapeutic index

- Major surgery within 4 weeks prior to enrollment.

- Known prior or suspected severe hypersensitivity to study interventions or any

component in their formulations.

- Investigator site staff members directly involved in the conduct of the study and

their family members, site staff members otherwise supervised by the investigator, or

Pfizer employees, including their family members, directly involved in the conduct of

the study.

Studien-Rationale

Primary outcome:

1. Percentage of Patients With Overall Objective Response (OR) based on independent central review (ICR) (Time Frame - every 6 weeks up to 3.5 years):
OR (Objective Response) based on ICR assessment is defined as complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.

Secondary outcome:

1. Percentage of Patients With Overall OR based on Investigator (INV) (Time Frame - every 6 weeks up to 3.5 years):
OR based on INV assessment is defined as CR or PR according to RECIST v1.1. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.

2. Percentage of Patients With Intra-Cranial Objective Response (IC-OR) based on ICR/derived INV (Time Frame - every 6 weeks up to 3.5 years):
IC-OR is defined as Intra-Cranial complete response (IC-CR) or partial response (IC-PR) according to RECIST v1.1. Both IC-CR and IC-PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.

3. Time to Response (TTR) based on ICR/derived INV (Time Frame - every 6 weeks up to 3.5 years):
TTR is defined, for participants with a confirmed OR, as the time from the date of first dose to the first documentation of objective response (CR or PR) which is subsequently confirmed.

4. Time to Intra-Cranial Response (IC-TTR) based on ICR/derived investigator (Time Frame - every 6 weeks up to 3.5 years):
IC-TTR is defined, for participants with a confirmed intra-cranial objective response, as the time from the date of first dose to the first documentation of objective intra-cranial response (CR or PR) which is subsequently confirmed.

5. Duration of Response (DoR) based on ICR/ derived investigator (Time Frame - every 6 weeks up to 3.5 years):
DoR is defined, for participants with a confirmed objective response, as the time from first documentation of objective response (CR or PR whichever is earlier) to the date of first documentation of PD or death due to any cause, whichever occurs first

6. Duration of Intra-Cranial Response (IC-DoR) based on ICR/ derived INV (Time Frame - every 6 weeks up to 3.5 years):
IC-DoR is defined, for participants with a confirmed objective intra-cranial response, as the time from first documentation of objective intra-cranial response (CR or PR whichever is earlier) to the date of first documentation of PD in brain or death due to any cause, whichever occurs first.

7. Progression Free Survival (PFS) based on ICR/derived INV (Time Frame - every 6 weeks up to 3.5 years):
PFS is defined as the time from date of first dose to the date of the first documentation of PD (per RECIST v1.1) or death due to any cause, whichever occurs first.

8. Time To Progression (TTP) based on ICR/derived INV (Time Frame - every 6 weeks up to 3.5 years):
TTP is defined as the time from date of first dose to the date of the first documentation of PD (per RECIST v1.1).

9. Adverse Event (AE) as graded by NCI CTCAE (v 4.03) (Time Frame - From study start up to 3.5 years):
Frequency of patients experiencing treatment-emergent AEs (TEAEs)

Geprüfte Regime

Lorlatinib:
25 milligram (mg) tablet

Quelle: ClinicalTrials.gov

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