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B7461027 - Single-Arm Study of Lorlatinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Generation ALK Tyrosine Kinase Inhibitor (TKI)

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: IV

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- 18 Years and older
- 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.

Criteri di esclusione: 

- 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.

Numero di pazienti previsti: 

25 (in Italia)

Schema di trattamento: 

Participants will take 100 mg (four, 25 mg tablets) once daily.

Trattamento sperimentale: 


Trattamento di controllo: 


Obiettivi primari dello studio: 

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.

Data di inizio dell'arruolamento: 08.10.2020

Data di fine dell'arruolamento: 15.06.2023

Centri partecipanti

Nord Italia

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Dipartimento di Oncologia Medica

Riferimento: Dr.ssa Alessandra Bulotta
Telefono: 0226437627


A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB
Oncologia Medica

Riferimento: Prof. Diego Cortinovis
Telefono: 0392339678


Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR
UOC Oncologia Medica - Dipartimento di Medica Generale e Specialistica

Riferimento: Prof. Marcello Tiseo


Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
SOC Oncologia Medica e dei Tumori Immunocorrelati

Riferimento: Dr.ssa Alessandra Bearz
Telefono: 0434659294


IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO
NB: Arruolamento pazienti non ancora attivo

Riferimento: Dr.ssa Vanesa Gregorc
Telefono: 0119933844


Centro Italia

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG
NB: Arruolamento pazienti non ancora attivo

Riferimento: Prof. Fausto Roila


Ospedale S. Salvatore
Via Lombroso 1 - 61122 Pesaro - PU

Riferimento: Dr.ssa Rita Chiari


Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM
UOSD Pneumologia Oncologica

Riferimento: Dr.ssa Maria Rita Migliorino
Telefono: 065554670


Sud Italia e isole

A.O.S.G. Moscati
Contrada Amoretta - 83100 Avellino - AV
U.O. Oncologia Medica

Telefono: 0825203945

Informazioni Generali


Numero di iscrizione a registro: 2019-002504-41

Data di inserimento: 25.01.2022

Data di aggiornamento: 28.03.2023





Principal Investigator ITALIA

Centro di Riferimento Oncologico di Aviano (PN)

Riferimento: Dr.ssa Alessandra Bearz

Telefono: 0434659294


Localita: Aviano (PN)


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