NCT06378892 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centro di Riferimento Oncologico - Aviano |
| Condition | Non Small Cell Lung Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2024-03-15 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06378892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06378892 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06378892 currently recruiting?
Yes, NCT06378892 is actively recruiting participants. Contact the research team at abearz@cro.it for enrollment information.
Where is the NCT06378892 trial being conducted?
This trial is being conducted at Aviano, Italy, Florence, Italy, Lido di Camaiore, Italy, Meldola, Italy and 5 additional locations.
Who is sponsoring the NCT06378892 clinical trial?
NCT06378892 is sponsored by Centro di Riferimento Oncologico - Aviano. The trial plans to enroll 45 participants.
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