Clinical trial NCT03052608: A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
Official title: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: ALK; anaplastic lymphoma kinase; Non-Small-Cell Lung cancer; NSCLC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment
timeFrame: From time of Study Start up to 33 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From time of Study Start up to 33 months
measure: Progression-Free Survival (PFS) Based on Investigator's Assessment
timeFrame: From time of Study Start up to 33 months
measure: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment
timeFrame: From time of Study Start up to 33 months
measure: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment
timeFrame: From time of Study Start up to 33 months
measure: Intracranial Objective Response Rate (IC-ORR) - Percentage of Participants With Intracranial Objective Response (IC-OR) Based on BICR Assessment
timeFrame: From time of Study Start up to 33 months
measure: Intracranial Time to Progression (IC-TTP) Based on BICR Assessment
timeFrame: From time of Study Start up to 33 months
measure: Duration of Response (DR) Based on BICR Assessment
timeFrame: From time of Study Start up to 33 months
measure: Intracranial Duration of Response (IC-DR) Based on BICR Assessment
timeFrame: From time of Study Start up to 33 months
measure: Time to Tumor Response (TTR) Based on BICR Assessment
timeFrame: From time of Study Start up to 33 months
measure: Intracranial Time to Tumor Response (IC-TTR) Based on BICR Assessment
timeFrame: From time of Study Start up to 33 months
measure: PFS2 Based on Investigator's Assessment
timeFrame: From time of Study Start up to 45 months
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs; All-Causality and Treatment-Related)
timeFrame: From time of Study Start up to 33 months
measure: Number of Participants With Changes in Hematology Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4
timeFrame: From Baseline up to 33 months
measure: Number of Participants With Changes in Chemistry Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4
timeFrame: From Baseline up to 33 months
measure: Number of Participants With Changes in Lipid Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4
timeFrame: From Baseline up to 33 months
measure: Number of Participant With Vital Signs and Body Weight Data Meeting Pre-defined Criteria
timeFrame: From Baseline up to 33 months
measure: Number of Participant With Maximum Increase From Baseline in Electrocardiogram (ECG) Data Meeting Pre-defined Criteria
timeFrame: From Baseline up to 33 months
measure: Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Points in Left Ventricular Ejection Fraction (LVEF) Percentage
timeFrame: From Baseline up to 33 months
measure: Change From Baseline in Total Scores of Beck Depression Inventory (BDI)-II (Mood Assessment) Across Time
timeFrame: Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C8D1, C10D1, C12D1, C14D1, C16D1, C18D1, C20D1, C22D1, C24D1, C26D1, C28D1, C30D1, C32D1, C34D1, C36D1, C38D1 and End of Treatment
measure: Number of Participants With Suicidal Ideation and Suicidal Behavior Across Time
timeFrame: Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C8D1, C10D1, C12D1, C14D1, C16D1, C18D1, C20D1, C22D1, C24D1, C26D1, C28D1, C30D1, C32D1, C34D1, C36D1, C38D1 and End of Treatment
measure: Change From Baseline in Global Quality of Life (QOL), Functional Scales and Symptoms Scales as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) During Overall Treatment
timeFrame: From Baseline up to Cycle 38 Day 1
measure: Change From Baseline in Lung Cancer Symptoms as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) During Overall Treatment
timeFrame: From Baseline up to Cycle 38 Day 1
measure: Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Visual Analogue Scale (VAS) Across Time
timeFrame: Baseline, Day 1 of all cycles from Cycle 2 to Cycle 38, and End of Treatment
measure: Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Index Across Time
timeFrame: Baseline, Day 1 of all cycles from Cycle 2 to Cycle 38, and End of Treatment
measure: Time to Deterioration (TTD) in Participant Reported Pain in Chest, Dyspnea, or Cough From QLQ-LC13
timeFrame: From Baseline up to 33 months
measure: Number of Participant With ALK Domain Mutation in Plasma Circulating Nucleic Acid (CNA) Analysis at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
timeFrame: at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
measure: Number of Participant With ALK Fusion Variant in Plasma Circulating Nucleic Acid (CNA) Analysis at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
timeFrame: at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
Other outcomes:
Locations:
city: Altamonte Springs
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Brandon
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Clearwater
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Largo
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lecanto
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orange City
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Spring Hill
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tavares
country: United States
facility: Florida Cancer Specialists
state: Florida
city: The Villages
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Winter Park
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston Inc
state: Massachusetts
city: Boston
country: United States
facility: The William P. Beetham Eye Institute, Joslin Diabetes Center
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester Cancer Center Pharmacy
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Dickson
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Gallatin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute.
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Shelbyville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Smyrna
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
state: Buenos Aires
city: Caba
country: Argentina
facility: Centro Medico Austral
city: Bendigo
country: Australia
facility: Bendigo Day Surgery Collection Centre and Laboratory
state: Victoria
city: Bendigo
country: Australia
facility: Bendigo Medical Imaging, Bendigo Hospital
state: Victoria
city: Bendigo
country: Australia
facility: Melbourne Pathology
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi - Site Notre Dame
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Beijing
country: China
facility: The Affiliated Hospital of Military Medical Sciences
state: Beijing
city: Changchun
country: China
facility: Jilin Provincial Cancer Hospital
state: Jilin
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Department of Respiratory,the First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc, Klinika plicnich nemoci a tuberkulozy
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Pessac
country: France
facility: Hopital Haut-Léveque-Centre François Magendie
state: Aquitaine
city: Chevilly Larue
country: France
facility: Hopital de Chevilly Larue
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Marseille cedex 09
country: France
facility: Institut Paoli-Calmettes
city: Marseille cedex 20
country: France
facility: Département d'Imagerie Médicale
city: Marseille cedex 20
country: France
facility: Hôpital Nord
city: Marseille cedex 20
country: France
facility: Service Ophtalmologie
city: Paris
country: France
facility: Groupe Hospitalier Bichat Claude Bernard, AP-HP
city: Rennes cedex 9
country: France
facility: CHU de Rennes Hopital Pontchaillou
city: Rennes cedex 9
country: France
facility: CHU de Rennes, Hopital Pontchaillou
city: Suresnes
country: France
facility: Hopital Foch
city: Toulouse Cedex 9
country: France
facility: Hopital Larrey
city: Toulouse cedex 9
country: France
facility: Hopital Pierre Paul Riquet
city: Toulouse Cedex 9
country: France
facility: Hôpital Larrey
city: Villejuif
country: France
facility: Department d'imagerie medicale
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Dresden
country: Germany
facility: Uberortliche Radiologische Gemeinschaftspraxis Dr. med. Marc Amler
city: Dresden
country: Germany
facility: Technische Universitat Dresden , Medizinische Fakultat Carl Gustav Carus
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Homburg - Saar
country: Germany
facility: Universitätsklinikum des Saarlandes, Innere Medizin V
city: Homburg - Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Regensburg
country: Germany
facility: Universitatsklinikum Regensburg, Institut fur Rontgendiagnostik
city: Regensburg
country: Germany
facility: Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong, Department of Clinical Oncology
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong, Department of Medicine
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Gurugram
country: India
facility: Artemis Hospital
state: Haryana
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Bangalore
country: India
facility: Srinivasam Cancer Care Multispeciality Hospitals India Pvt Ltd
state: Karnataka
city: Pune
country: India
facility: Sahyadri Clinical Research and Development Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Specialty Hospital
state: Maharashtra
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico
state: CT
city: Monza
country: Italy
facility: ASST Monza - A.O. San Gerardo
state: MB
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: MI
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Ospedale S. M. Misericordia
state: PG
city: Pordenone
country: Italy
facility: Centro di Riferimento Oncologico-IRCCS
state: PN
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: PR
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
state: RM
city: Roma
country: Italy
facility: Az.Osp.San Camillo-Forlanini
state: RM
city: Napoli
country: Italy
facility: Azienda Ospedaliera Dei Colli Ospedale Monaldi
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori di Napoli
city: Ravenna
country: Italy
facility: Ausl della Romagna- Ravenna
city: Nagoya
country: Japan
facility: Aichi cancer center central hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Ube
country: Japan
facility: National Hospital Organization, Yamaguchi-Ube Medical Center
state: Yamaguchi
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Department of Pulmonary Medicine and Oncology
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincents Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Division of Medical Oncology, Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Aguascalientes
country: Mexico
facility: Médicos Especialistas en Cancer S.C. / San Peregrino.
city: Distrito Federal
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Distrito Federal
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Gdansk
country: Poland
facility: Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o.o.
city: Szczecin
country: Poland
facility: Centrum Medyczne Dom Lekarski S.A.
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
city: Kislino
country: Russian Federation
facility: RBHI Kursk Regional Clinical Oncology Dispensary
state: Kursk Region
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution Omsk Region "Clinical Oncological Dispensary"
state: OMSK Region
city: Pesochniy Poselok
country: Russian Federation
facility: LEC at SBIH "Saint-Petersburg Clinical Research Practical Center of specialized types of
state: Saint-petersburg
city: Pushkin
country: Russian Federation
facility: Private Medical Institution "Euromedservice"
state: Saint-petersburg
city: Kursk
country: Russian Federation
facility: RBHI Kursk Regional Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: FSBI "N.N.Blokhin Medical Research Center of Oncology"
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Raffles Hospital
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia L'Hospitalet
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
state: Canarias
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario De Navarra
state: Navarra
city: A Coruna
country: Spain
facility: Hospital Teresa Herrera C.H.U.A.C.
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Girona
country: Spain
facility: Institut Catala d'Oncologia Girona
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Taiwan ROC
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung Branch
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Oncology Institute
city: Istanbul
country: Turkey
facility: Marmara Univ Pendik Training and Research Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Ipswich
country: United Kingdom
facility: The Ipswich Hospital NHS Trust
state: Suffolk
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital
state: WEST Midlands
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Solomon BJ, Bauer TM, Ignatius Ou SH, Liu G, Hayashi H, Bearz A, Penkov K, Wu YL, Arrieta O, Jassem J, Calella AM, Peltz G, Polli A, Thurm H, Mok T. Post Hoc Analysis of Lorlatinib Intracranial Efficacy and Safety in Patients With ALK-Positive Advanced Non-Small-Cell Lung Cancer From the Phase III CROWN Study. J Clin Oncol. 2022 Nov 1;40(31):3593-3602. doi: 10.1200/JCO.21.02278. Epub 2022 May 23.
citation: Solomon BJ, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Shaw AT. Plain language summary of the CROWN study comparing lorlatinib with crizotinib for people with untreated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(34):4649-4656. doi: 10.2217/fon-2021-0904. Epub 2021 Sep 29.
citation: Shaw AT, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Solomon BJ; CROWN Trial Investigators. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med. 2020 Nov 19;383(21):2018-2029. doi: 10.1056/NEJMoa2027187.
citation: Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. doi: 10.1016/S1470-2045(17)30680-0. Epub 2017 Oct 23.
citation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available.