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JOURNAL ONKOLOGIE – STUDIE

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Rekrutierend

NCT-Nummer:
NCT03052608

Studienbeginn:
April 2017

Letztes Update:
20.01.2021

Wirkstoff:
Lorlatinib, Crizotinib

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

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 167)

Uberortliche Radiologische Gemeinschaftspraxis Dr. med. Marc Amler
01309 Dresden
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Technische Universitat Dresden , Medizinische Fakultat Carl Gustav Carus
D-01307 Dresden
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Thoraxklinik Heidelberg gGmbH
D-69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Heidelberg
D-69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätsklinikum des Saarlandes, Innere Medizin V
66421 Homburg - Saar
(Saarland)
GermanyNoch nicht rekrutierend» Google-Maps
Universitäts-Brustzentrum am Universitätsklinikum des Saarlandes
Kirrberger Straße 100
66424 Homburg
DeutschlandNoch nicht rekrutierend» Google-Maps
Universitatsklinikum Regensburg, Institut fur Rontgendiagnostik
93053 Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II
93053 Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps
Florida Cancer Specialists
32701 Altamonte Springs
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33511 Brandon
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33761 Clearwater
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32605 Gainesville
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33770 Largo
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34461 Lecanto
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34655 New Port Richey
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32763 Orange City
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32806 Orlando
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33705 Saint Petersburg
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34608 Spring Hill
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33607 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32778 Tavares
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32159 The Villages
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32792 Winter Park
United StatesAktiv, nicht rekrutierend» Google-Maps
Massachusetts Eye and Ear Infirmary
02114 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
Ophthalmic Consultants of Boston Inc
02114 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
The William P. Beetham Eye Institute, Joslin Diabetes Center
02215 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Rochester Cancer Center Pharmacy
14642 Rochester
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Rochester Medical Center
14642 Rochester
United StatesAktiv, nicht rekrutierend» Google-Maps
Tennessee Oncology, PLLC
37055 Dickson
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37067 Franklin
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37066 Gallatin
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37076 Hermitage
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37090 Lebanon
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37129 Murfreesboro
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37203 Nashville
United StatesAbgebrochen» Google-Maps
The Sarah Cannon Research Institute.
37203 Nashville
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37205 Nashville
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37207 Nashville
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37211 Nashville
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37160 Shelbyville
United StatesAbgebrochen» Google-Maps
Tennessee Oncology, PLLC
37167 Smyrna
United StatesAbgebrochen» Google-Maps
University of Washington Medical Center
98195 Seattle
United StatesAktiv, nicht rekrutierend» Google-Maps
Centro de Investigacion Pergamino SA
B2700CPM Pergamino
ArgentinaRekrutierend» Google-Maps
Bendigo Day Surgery Collection Centre and Laboratory
3550 Bendigo
AustraliaRekrutierend» Google-Maps
Bendigo Medical Imaging, Bendigo Hospital
3550 Bendigo
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Grand Hopital de Charleroi - Site Notre Dame
6000 Charleroi
BelgiumAktiv, nicht rekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
McGill University Health Centre
H4A 3J1 Montreal
CanadaRekrutierend» Google-Maps
The Affiliated Hospital of Military Medical Sciences
100071 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps
Jilin Provincial Cancer Hospital
130012 Changchun
ChinaAktiv, nicht rekrutierend» Google-Maps
Department of Respiratory,the First Affiliated Hospital of College of Medicine, Zhejiang University
310003 Hangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps
The Second Affiliated Hospital of Zhejiang University School of Medicine
310009 Hangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps
Guangdong General Hospital
510000 Guangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps
Fakultni nemocnice Olomouc, Klinika plicnich nemoci a tuberkulozy
779 00 Olomouc
CzechiaAktiv, nicht rekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze
128 08 Praha 2
CzechiaRekrutierend» Google-Maps
Hopital Haut-Léveque-Centre François Magendie
33604 Pessac
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital de Chevilly Larue
94550 Chevilly Larue
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Paoli-Calmettes
13273 Marseille cedex 09
FranceRekrutierend» Google-Maps
Département d'Imagerie Médicale
13915 Marseille cedex 20
FranceRekrutierend» Google-Maps
Service Ophtalmologie
13915 Marseille cedex 20
FranceRekrutierend» Google-Maps
Clinique Monticelli-Paradis-Dr Stephan Fauquier
13008 Marseille
FranceRekrutierend» Google-Maps
Groupe Hospitalier Bichat Claude Bernard, AP-HP
75018 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
CHU de Rennes Hopital Pontchaillou
35033 Rennes cedex 9
FranceAbgebrochen» Google-Maps
CHU de Rennes, Hopital Pontchaillou
35033 Rennes cedex 9
FranceAbgebrochen» Google-Maps
Hopital Larrey
31059 Toulouse Cedex 9
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Pierre Paul Riquet
31059 Toulouse cedex 9
FranceAktiv, nicht rekrutierend» Google-Maps
Hôpital Larrey
31059 Toulouse Cedex 9
FranceAktiv, nicht rekrutierend» Google-Maps
Department d'imagerie medicale
94805 Villejuif
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Gustave Roussy
94805 Villejuif
FranceAktiv, nicht rekrutierend» Google-Maps
The University of Hong Kong, Department of Clinical Oncology
Hong Kong
Hong KongAktiv, nicht rekrutierend» Google-Maps
The University of Hong Kong, Department of Medicine
Hong Kong
Hong KongAktiv, nicht rekrutierend» Google-Maps
Tuen Mun Hospital
Hong Kong
Hong KongAktiv, nicht rekrutierend» Google-Maps
Artemis Hospital
122001 Gurugram
IndiaAktiv, nicht rekrutierend» Google-Maps
Srinivasam Cancer Care Multispeciality Hospitals India Pvt Ltd
560072 Bangalore
IndiaAktiv, nicht rekrutierend» Google-Maps
Sahyadri Clinical Research and Development Centre
411004 Pune
IndiaAktiv, nicht rekrutierend» Google-Maps
Sahyadri Specialty Hospital
411004 Pune
IndiaAktiv, nicht rekrutierend» Google-Maps
AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico
95123 Catania
ItalyAktiv, nicht rekrutierend» Google-Maps
IRCCS Ospedale San Raffaele
20132 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera di Perugia - Ospedale S. M. Misericordia
06132 Perugia
ItalyRekrutierend» Google-Maps
Centro di Riferimento Oncologico-IRCCS
33081 Pordenone
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria di Parma
43126 Parma
ItalyAbgebrochen» Google-Maps
Istituto Nazionale Tumori Regina Elena
00144 Roma
ItalyAktiv, nicht rekrutierend» Google-Maps
Azienda Ospedaliera Dei Colli Ospedale Monaldi
80131 Napoli
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori di Napoli
80131 Napoli
ItalyRekrutierend» Google-Maps
Ausl della Romagna- Ravenna
48121 Ravenna
ItalyAktiv, nicht rekrutierend» Google-Maps
Aichi cancer center central hospital
464-8681 Nagoya
JapanAbgebrochen» Google-Maps
Nagoya University Hospital
466-8560 Nagoya
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama
JapanAktiv, nicht rekrutierend» Google-Maps
Kurume University Hospital
830-0011 Kurume
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanAktiv, nicht rekrutierend» Google-Maps
Kanazawa University Hospital
920-8641 Kanazawa
JapanAbgebrochen» Google-Maps
Kanagawa Cancer Center
241-8515 Yokohama
JapanAktiv, nicht rekrutierend» Google-Maps
Sendai Kousei Hospital
980-0873 Sendai
JapanAktiv, nicht rekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Kindai University Hospital
589-8511 Osakasayama
JapanAktiv, nicht rekrutierend» Google-Maps
Shizuoka Cancer Center
411-8777 Sunto-gun
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-Ku
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization, Yamaguchi-Ube Medical Center
755-0241 Ube
JapanAktiv, nicht rekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Koto-ku, Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanAktiv, nicht rekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanAktiv, nicht rekrutierend» Google-Maps
Osaka City General Hospital
534-0021 Osaka
JapanAktiv, nicht rekrutierend» Google-Maps
Tokushima University Hospital
770-8503 Tokushima
JapanAktiv, nicht rekrutierend» Google-Maps
Wakayama Medical University Department of Pulmonary Medicine and Oncology
641-8509 Wakayama
JapanAktiv, nicht rekrutierend» Google-Maps
The Catholic University of Korea, St. Vincents Hospital
16247 Suwon
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Division of Medical Oncology, Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Ulsan University Hospital
44033 Ulsan
Korea, Republic ofRekrutierend» Google-Maps
Promotora Medica Aguascalientes SA de CV
20230 Aguascalientes
MexicoRekrutierend» Google-Maps
Instituto Nacional de Cancerologia
14080 Distrito Federal
MexicoRekrutierend» Google-Maps
Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas
14080 Distrito Federal
MexicoRekrutierend» Google-Maps
University Medical Center Groningen
9713 GZ Groningen
NetherlandsRekrutierend» Google-Maps
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
80-214 Gdansk
PolandAktiv, nicht rekrutierend» Google-Maps
Centrum Medyczne Dom Lekarski S.A.
70-784 Szczecin
PolandRekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
02-781 Warszawa
PolandRekrutierend» Google-Maps
RBHI Kursk Regional Clinical Oncology Dispensary
305 524 Kislino, Ryshkovsky Rural Council
Russian FederationAbgebrochen» Google-Maps
Budgetary Healthcare Institution Omsk Region "Clinical Oncological Dispensary"
644013 Omsk
Russian FederationRekrutierend» Google-Maps
LEC at SBIH "Saint-Petersburg Clinical Research Practical Center of specialized types of
197758 Pesochniy Poselok
Russian FederationRekrutierend» Google-Maps
Private Medical Institution "Euromedservice"
196603 Pushkin
Russian FederationRekrutierend» Google-Maps
RBHI Kursk Regional Clinical Oncology Dispensary
305 035 Kursk
Russian FederationAbgebrochen» Google-Maps
FSBI "N.N.Blokhin Medical Research Center of Oncology"
115478 Moscow
Russian FederationRekrutierend» Google-Maps
National University Hospital
119074 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
Raffles Hospital
188770 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
Institut Catala d'Oncologia L'Hospitalet
08908 L'Hospitalet de Llobregat
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Insular de Gran Canaria
35016 Las Palmas de Gran Canaria
SpainAbgebrochen» Google-Maps
Hospital Universitario Puerta de Hierro Majadahonda
28222 Majadahonda
SpainAktiv, nicht rekrutierend» Google-Maps
Complejo Hospitalario De Navarra
31008 Pamplona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Teresa Herrera C.H.U.A.C.
15006 A Coruna
SpainRekrutierend» Google-Maps
Hospital De La Santa Creu I Sant Pau
08025 Barcelona
SpainAbgebrochen» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinic i Provincial de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital De La Santa Creu I Sant Pau
08041 Barcelona
SpainAbgebrochen» Google-Maps
Institut Catala d'Oncologia Girona
17007 Girona
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico San Carlos
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Fundacion Jimenez Diaz
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Memorial Hospital - Kaohsiung Branch
83301 Kaohsiung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Chung Shan Medical University Hospital
402 Taichung
TaiwanAbgebrochen» Google-Maps
Taichung Veterans General Hospital
40705 Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taipei Veterans General Hospital
112 Taipei
TaiwanRekrutierend» Google-Maps
Cukurova University Medical Faculty
01330 Adana
TurkeyAktiv, nicht rekrutierend» Google-Maps
Istanbul University Oncology Institute
34093 Istanbul
TurkeyAktiv, nicht rekrutierend» Google-Maps
Marmara Univ Pendik Training and Research Hospital
34899 Istanbul
TurkeyAbgebrochen» Google-Maps
The Ipswich Hospital NHS Trust
IP4 5PD Ipswich
United KingdomAktiv, nicht rekrutierend» Google-Maps
Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital
B9 5SS Birmingham
United KingdomAktiv, nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to

crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC

patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to

overall survival in the same population

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic

ALK-positive NSCLC; at least 1 extracranial measurable target lesion not previously

irradiated. CNS metastases allowed if asymptomatic and not currently requiring

corticosteroid treatment.

- Availability of an archival FFPE tissue specimen.

- No prior systemic NSCLC treatment.

- ECOG PS 0, 1, or 2.

- Age ≥18 years .

- Adequate Bone Marrow, Liver, Renal, Pancreatic Function

- Negative pregnancy test for females of childbearing potential

Exclusion Criteria:

- Spinal cord compression unless good pain control attained

- Major surgery within 4 weeks prior to randomization.

- Radiation therapy within 2 weeks prior to randomization, including stereotactic or

partial brain irradiation. Whole brain irradiation within 4 weeks prior to

randomization

- Active bacterial, fungal, or viral infection

- Clinically significant cardiovascular disease, active or within 3 months prior to

enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,

bradycardia or congenital long QT syndrome

- Predisposing characteristics for acute pancreatitis in the last month prior to

randomization.

- History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial

fibrosis or interstitial lung disease

- Active malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical

cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate

cancer) within the last 3 years prior to randomization.

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

dose of lorlatinib or crizotinib.

1. known strong CYP3A inhibitors .

2. known strong CYP3A inducers

3. known P gp substrates with a narrow therapeutic index

- Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days

prior to the first dose of lorlatinib or crizotinib.

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

active suicidal ideation or behavior, or laboratory abnormality that may increase the

risk associated with study participation or interfere with the interpretation of study

results

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

their family members, or Pfizer employees, including their family members, directly

involved in the conduct of the study.

- Participation in other studies involving investigational drug(s) within 2 weeks prior

to study entry and/or during study participation.

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) based on blinded independent central review (BICR) assessment (Time Frame - From time of Study Start up to 33 months):
PFS is defined as the time from randomization to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.



Secondary outcome:

1. Overall Survival (OS) (Time Frame - From time of Study Start up to 125 months):
OS is defined as time from date of randomization to date of death due to any cause

2. PFS based on Investigator's assessment (Time Frame - From time of Study Start up to 33 months):
PFS is defined as the time from randomization to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.

3. Objective Response (OR) based on BICR and on Investigator's assessments (Time Frame - From time of Study Start up to 33 months):
OR defined as complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy

4. Intracranial Objective Response (IC-OR) based on BICR assessment (Time Frame - From time of Study Start up to 33 months):
IC-OR defined as complete response (CR) or partial response (PR) based on intracranial disease in the subset of patients with at least 1 intracranial lesion per RECIST version 1.1 (modified) recorded from randomization until disease progression or start of new anti-cancer therapy

5. Intracranial Time to Progression (IC-TTP) based on BIRC assessment (Time Frame - From time of Study Start up to 33 months):
IC-TTP defined as the time from randomization to the date of the first documentation of objective progression of intracranial disease, based on either new brain metastases or progression of existing brain metastases

6. Duration of Response (DR) based on BIRC assessment (Time Frame - From time of Study Start up to 33 months):
DR defined, for patients with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first

7. intracranial Duration of Response (IC-DR) based on BICR assessment (Time Frame - From time of Study Start up to 33 months):
IC-DR defined, for patients with an IC-BOR of CR or PR, as the time from the first documentation of intracranial objective response (CR or PR) per RECIST 1.1 to the date of first documentation of intracranial objective progression of disease (PD) or death due to any cause.

8. Time to Tumor Response (TTR) based on BIRC assessment (Time Frame - From time of Study Start up to 33 months):
TTR defined, for patients with a confirmed OR, as the time from the date of randomization to the first documentation of objective response (CR or PR) which is subsequently confirmed

9. Intracranial Time to Tumor Response (IC-TTR) based on BICR assessment (Time Frame - from time of Study Start up to 33 months):
IC-TTR is defined, for patients with a confirmed IC-OR, as the time from the date of randomization to the first documentation of intracranial objective response (CR or PR) which is subsequently confirmed.

10. PFS2 based on investigator's assessment (Time Frame - From time of Study Start up to 45 months):
PFS2 is defined as the time from randomization to the date of progression of disease on first subsequent systemic anti-cancer therapy, or death from any cause, whichever occurs first

11. Adverse Event (AE) as graded by NCI CTCAE v 4.03) (Time Frame - From time of Study Start up to 33 months):
Frequency of patients experiencing treatment-emergent AEs (TEAEs)

12. Laboratory abnormalities as graded by NCI CTCAE v 4.03) (Time Frame - From time of Study Start up to 33 months):
Frequency of patients with laboratory test abnormalities

13. Vital signs (blood pressure, pulse rate) and body weight (Time Frame - From time of Study Start up to 33 months):
Summary of actual values and changes from baseline

14. Electrocardiograms (ECG) (Time Frame - From time of Study Start up to 33 months):
Summary of actual values and changes from baseline

15. Echocardiograms or multigated acquisition scan (MUGA) (Time Frame - From time of Study Start up to 33 months):
Summary of actual values and changes from baseline

16. Ophthalmology (Time Frame - From time of Study Start up to 33 months):
Summary of changes from screning results

17. PRO as assessed by EORTC QLQ-C30, EORTC QLQ LC13, and EQ-5D-5L (Time Frame - From time of Study Start up to 33 months):
Summary of absolute scores and mean change of absolute scores from baseline

18. Tumor tissue biomarkers (Time Frame - From time of Study Start up to 33 months):
Summary of baseline levels and changes from baseline

19. Peripheral blood cfDNA (circulating free Deoxyribonucleic acid) biomarkers (Time Frame - From time of Study Start up to 33 months):
Summary of baseline levels and changes from baseline

Studien-Arme

  • Experimental: Lorlatinib
    Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
  • Active Comparator: Crizotinib
    Crizotinib single agent, 250 mg (1 x 250) oral capsules, BID, continuously

Geprüfte Regime

  • Lorlatinib (PF-06463922):
    ALK-positive NSCL treatment
  • Crizotinib (Xalkori):
    ALK-positive NSCL treatment

Quelle: ClinicalTrials.gov


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Kinder mit Leukämie – eine Herausforderung für die ganze Familie
© pingpao - stock.adobe.com

Wird bei einem Kind Leukämie diagnostiziert, so hat das für die ganze Familie dramatische Veränderungen zur Folge. Neben den gesundheitlichen Sorgen, tun sich weitere Problemfelder auf: Wie kann der Alltag organisiert werden trotz hoher physischer und emotionaler Belastung? Wie lassen sich Beruf, Betreuung des kranken Kindes in der Klinik und die Fürsorge für die Geschwister vereinbaren und welche finanziellen Konsequenzen hat das? Zum Weltleukämietag am 28. Mai...

Brustkrebs bei Männern

Brustkrebs bei Männern
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Jährlich erkranken zwischen 600 und 700 Männer an Brustkrebs. Das macht rund ein Prozent aller Brustkrebsfälle aus. Da es für Männer keine Brustkrebs-Früherkennungsprogramme gibt und der Gedanke an Krebs zunächst fern liegt, wird die Erkrankung beim Mann meist erst in späteren Stadien diagnostiziert als bei Frauen. Dadurch verstreicht wertvolle Zeit, die bei der Behandlung fehlt. Wie Brustkrebs beim Mann entsteht, erkannt und behandelt wird,...

Mit neuer Website „psyche-hilft-koerper.de“ finden Krebspatienten schnell und einfach psychoonkologische Hilfe

Mit neuer Website „psyche-hilft-koerper.de“ finden Krebspatienten schnell und einfach psychoonkologische Hilfe
© www.psyche-hilft-koerper.de

Die Website „psyche-hilft-koerper.de“ ermöglicht es, über eine Postleitzahl-Suche Psychoonkologen in der Region, in der man lebt, zu finden. Eine psychoonkologische Betreuung unterstützt Patienten u. a. dabei, ihre Krebserkrankung zu verarbeiten, das seelische Befinden zu verbessern sowie körperliche Ressourcen zu stärken (1). Novartis Oncology hat sich nicht nur der Entwicklung innovativer Arzneimittel verpflichtet, sondern möchte durch Initiativen...