Actively Recruiting
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
Led by Centro di Riferimento Oncologico - Aviano · Updated on 2024-04-23
45
Participants Needed
9
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of stage IV ALK positive Non-Small Cell Lung Cancer
- Extracranial disease progression on Lorlatinib treatment
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease by CT and MRI according to RECIST 1.1 criteria
- Multiple extracranial progression without brain progression or stable brain metastases
- Adequate kidney, bone marrow, and liver function
- Estimated life expectancy of at least 3 months
- Agreement to use effective contraception or abstain from heterosexual intercourse during treatment and for 6 months after last dose for patients of childbearing potential
You will not qualify if you...
- Known allergy or hypersensitivity to study drugs or compounds used
- Diagnosis of secondary cancer within last 3 years except certain treated skin, cervical, or prostate cancers
- Unsuitability for chemo-Lorlatinib treatment as judged by investigator
- Existing toxicities preventing continuation of Lorlatinib therapy
- Use of strong CYP3A4/5 inducer medications
- Other criteria as applicable
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Centro di Riferimento Oncologico (CRO) IRCCS
Aviano, Italy, 33081
Actively Recruiting
2
Azienda Ospedaliero-Universitaria Careggi Oncologia Medica
Florence, Italy, 50134
Not Yet Recruiting
3
Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia
Lido di Camaiore, Italy, 55049
Not Yet Recruiting
4
Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori"
Meldola, Italy, 47014
Not Yet Recruiting
5
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Not Yet Recruiting
6
IOV Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Not Yet Recruiting
7
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Not Yet Recruiting
8
Azienda Ospedaliera di Perugia
Perugia, Italy, 06129
Not Yet Recruiting
9
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine, Italy, 33010
Not Yet Recruiting
Research Team
A
Alessandra Bearz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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