Trial Title:
A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib
NCT ID:
NCT06378892
Condition:
Non Small Cell Lung Cancer Metastatic
ALK Gene Mutation
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Disease Progression
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lorlatinib
Description:
Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an
induction phase of four cycles. The choice between Carboplatin or Cisplatin is entrusted
to the clinician. Subsequently, patients with response or stability of disease at
radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in
21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent.
Arm group label:
Lorlatinib
Summary:
This study aims to evaluate the activity and safety of the combination of
platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell
Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib.
Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an
induction phase of four cycles. Subsequently, patients with response or stability of
disease at radiological assessment will start the maintenance phase with
pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death,
or withdrawal of consent.
Detailed description:
This is a multicentre, phase II, interventional, prospective, single arm, non-randomised
study focused on ALK+ NSCLC with extracranial progression on Lorlatinib.Treatment phase
include the period starting from cycle 1 day 1 visit to discontinuation of study therapy
and consists of two phases: induction phase and maintenance phase. Platinum-pemetrexed
based chemotherapy plus Lorlatinib will be administered for an induction phase of four
cycles. Subsequently, patients with response or stability of disease at radiological
assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles
until progression, unacceptable toxicity, death, or withdrawal of consent.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC.
- Patients must be in progression extracranially on Lorlatinib; Lorlatinib may be in
first- or further-line, without limitations regarding previously received therapies.
- Age at the time of signing the informed consent at least 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients must have measurable disease according to RECIST 1.1 by computed tomography
(CT) and magnetic resonance imaging (MRI).
- Radiologically confirmed multiple extracranial progression on Lorlatinib without
progression in the central nervous system (CNS) defined as absence of CNS metastasis
or CNS metastasis stable on Lorlatinib and/or stereotactic brain irradiation (SBRT).
- Adequate organ function (kidney, bone marrow and liver).
- Estimated life expectancy of at least 3 months irrespective of the diagnosis of ALK+
NSCLC.
- For women of childbearing potential and males with partners of childbearing
potential: agreement to remain abstinent (refrain from heterosexual intercourse) or
use contraceptive methods that result in a failure rate of < 1% per year during the
treatment period and for at least 6 months after the last dose of study drugs.
Key Exclusion Criteria:
- Known hypersensitivity reaction to one of the compounds or substances used in this
protocol.
- Diagnosis of any secondary malignancy within the last 3 years except for: adequately
treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix,
definitively treated nonmetastatic prostate cancer or patients with another primary
malignancy who are definitively relapse-free with at least 3 years elapsed since the
diagnosis of the other primary malignancy.
- Patients deemed unsuitable by the investigator for treatment of chemo-Lorlatinib
combination.
- Presence of toxicities contraindicating the continuation of therapy with Lorlatinib.
- Concomitant use of potent CYP3A4/5 inducers.
Other inclusion/exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO) IRCCS
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandra Bearz
Phone:
0434659294
Email:
abearz@cro.it
Facility:
Name:
Azienda Ospedaliero-Universitaria Careggi Oncologia Medica
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Lorenzo Antonuzzo
Phone:
0557947298
Email:
antonuzzol@aou-careggi.toscana.it
Facility:
Name:
Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia
Address:
City:
Lido Di Camaiore
Zip:
55049
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Camerini Andrea
Phone:
05846057282
Email:
andrea.camerini@uslnordovest.toscana.it
Facility:
Name:
Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori"
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Delmonte Angelo
Phone:
0543739100
Email:
angelo.delmonte@irst.emr.it
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori
Address:
City:
Monza
Zip:
20900
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Cortinovis Diego Luigi
Phone:
0392336040
Email:
diegoluigi.cortinovis@irccs-sangerardo.it
Facility:
Name:
IOV Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Pasello Giulia
Phone:
0498215608
Email:
giulia.pasello@iov.veneto.it
Facility:
Name:
Azienda Ospedaliero-Universitaria di Parma
Address:
City:
Parma
Zip:
43126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Tiseo Marcello
Phone:
0521702316
Email:
mtiseo@ao.pr.it
Facility:
Name:
Azienda Ospedaliera di Perugia
Address:
City:
Perugia
Zip:
06129
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Metro Giulio
Phone:
0755783695
Email:
giulio.metro@ospedale.perugia.it
Facility:
Name:
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Address:
City:
Udine
Zip:
33010
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giacomo Pellizzari
Phone:
0432552754
Email:
giacomo.pelizzari@asufc.sanita.fvg.it
Start date:
March 15, 2024
Completion date:
May 2028
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378892
