PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer

NCT03439215 | Unknown Phase 2

• 1 other identifier: FoRT 01/2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 20

Brief Summary

This is a phase II study assessing response rate to PF-06463922 in patients with ROS1 translocation resistant to previous crizotinib therapy. Eligible patients will be treated with the study drug until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks according to RECIST criteria.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

ROS1 positive; NSCLC

Outcome Measures

Primary Outcomes (1)

• Response rate to PF-06463922 in patients with ROS1 translocation resistant to crizotinib

  Response rate to PF-06463922 in patients with ROS1 translocation resistant to crizotinib

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 months

Secondary Outcomes (4)

• Progression-free survival (PFS), The length of time during and after the treatment of a disease,that a patient lives with the disease but it doesn't get worse.

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 months

• Overall Survival (OS): Time from the start of treatment until death from any cause

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 months

• Correlation with additional tumor biomarkers in tumor tissue or blood

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 months

Study Arms (1)

Lorlatinb Arm

EXPERIMENTAL

Eligible patients will be treated with Lorlatinib at the dose of 100 mg QD p.o.

Drug: Lorlatinib

Interventions

Lorlatinib DRUG

Lorlatinib is a novel small-molecule ROS1/ALK inhibitor that was optimized for robust brain penetration.

Also known as: Lorlatinb

Lorlatinb Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• Male or female patient ages ≥ 18 years;
• Histologically/cytologically confirmed diagnosis of NSCLC with evidence of ROS1 rearrangement;
• Possibility to perform a new tumor biopsy or tumor tissue collected at the time or after crizotinib failure;
• Patient pretreated with crizotinib with evidence of disease progression during crizotinib therapy;
• At least one radiological measurable disease according to RECIST criteria;
• At least 1 previous standard chemotherapy regimen;
• Performance status 0-2 (ECOG);
• Patient compliance to trial procedures
• Adequate bone marrow function (ANC ≥ 1.5x109/L, platelets ≥ 100x109/L, haemoglobin \> 9 g/dl);
• Adequate liver function (bilirubin \< grade 2, transaminases no more than 3xULN/\<5xULN in present of liver metastases);
• Normal level of alkaline phosphatase and creatinine;
• If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method \[intrauterine contraceptive device (IUD), birth control pills, or barrier device\] during and for ninety (90) days after end of treatment.

You may not qualify if:

• \. No ROS1 rearrangement 2. No previous therapy with crizotinib; 3. No evidence of crizotinib failure; 4. No post-crizotinib tumor tissue available; 5. Absence of any measurable lesions; 6. No previous chemotherapy; 7. Concomitant radiotherapy or chemotherapy; 8. Symptomatic brain metastases; 9. Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin; 10. Predisposing factors for acute pancreatitis (e.g., uncontrolled hyperglycaemia, current gallstone disease, alcoholism); 11. History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis (but not history of prior radiation pneumonitis); 12. Pregnancy or lactating female; 13. Other serious illness or medical condition potentially interfering with the study.

Sponsors & Collaborators

• Fondazione Ricerca Traslazionale: lead
• Clinical research technology Srl: collaborator

Study Sites (20)

IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)- Oncologia Medica

Meldola, Forlì- Cesena, 47014, Italy

Location

Sacro Cuore- Don Calabria Hospital- U.O.C. Oncologia Medica

Negrar, Verona, 37024, Italy

Location

Istituto Toscano Tumori Ospedale San Donato- U.O.C. di Oncologia Medica Dipartimento di Oncologia USL-8

Arezzo, 52100, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"

Avellino, 83100, Italy

Location

IRCCS Istituto Tumori Giovanni Paolo II

Bari, 70124, Italy

Location

IRCCS A.O.U. San Martino- IST- Istituto Nazionale per la Ricerca sul Cancro- U.O.S. Tumori Polmonari

Genova, 16132, Italy

Location

Istituto Europeo di Oncologia - Divisione di Oncologia Toracica

Milan, 20141, Italy

Location

A.O.U. Policlinico di Modena- Oncologia Ematologia e Malattie Apparato Respiratorio

Modena, 41124, Italy

Location

A.O. San Gerardo

Monza, 20900, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, 80131, Italy

Location

Istituto Oncologico Veneto IRCCS- UOS Oncologia Toracica UOC. Oncologia Medica 2

Padua, 35128, Italy

Location

Casa di Cura La Maddalena- U.O. Oncologia medica

Palermo, 90146, Italy

Location

Azienda Ospedaliera Universitaria di Parma- Struttura Complessa di Oncologia Medica

Parma, 43126, Italy

Location

Azienda Ospedaliera di Perugia- S.C. Oncologia Medica

Perugia, 06132, Italy

Location

Ospedale di Ravenna- Oncologia Medica

Ravenna, 48121, Italy

Location

Ospedale "Infermi" Rimini

Rimini, 47900, Italy

Location

ASST della Valle Olona - Ospedale di Saronno

Saronno, 21047, Italy

Location

A.O.U. San Luigi Gonzaga

Torino, 10043, Italy

Location

Azienda ULSS 9 TREVISO-UOC Oncologia Medica

Treviso, 31100, Italy

Location

Policlinico 'G.B.Rossi' Borgo Roma - A.O.U. Integrata (Giampaolo Tortora)- Oncologia Medica

Verona, 37134, Italy

Location

Related Links

• PFROST trial

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

lorlatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 20, 2018
• Study Start: June 13, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)