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New treatment option for Non Small Cell Lung Cancer Metastatic
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
ClinicalTrials.gov ID: NCT06378892
What this study is testing
What is Lorlatinib?
Lorlatinib is an investigational medicine, being studied as a potential treatment for non small cell lung cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aviano, Italy
- Florence, Italy
- Lido di Camaiore, Italy
- Meldola, Italy
- Monza, Italy
- Padova, Italy
- Parma, Italy
- Perugia, Italy
- Udine, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aviano, Italy; Florence, Italy; Lido di Camaiore, Italy; Meldola, Italy; Monza, Italy; Padova, Italy and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.