Combining chemotherapy with Lorlatinib for ALK positive lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of combining platinum-pemetrexed based chemotherapy with Lorlatinib in patients with ALK positive Non-Small Cell Lung Cancer (NSCLC) who have experienced extracranial disease progression while on Lorlatinib. The treatment consists of an induction phase with four cycles of chemotherapy and Lorlatinib, followed by a maintenance phase for those who show a response or stable disease. The study is multicenter and non-randomized, focusing on a specific patient population with measurable disease. Patients will be monitored for disease progression, toxicity, and overall survival.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centro di Riferimento Oncologico (CRO) IRCCS
  Aviano, Italy Recruiting
• Azienda Ospedaliero-Universitaria Careggi Oncologia Medica
  Florence, Italy Not yet recruiting
• Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia
  Lido di Camaiore, Italy Not yet recruiting
• Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori"
  Meldola, Italy Not yet recruiting
• Fondazione IRCCS San Gerardo dei Tintori
  Monza, Italy Not yet recruiting
• IOV Istituto Oncologico Veneto IRCCS
  Padova, Italy Not yet recruiting

Study contacts

• Study coordinator: Alessandra Bearz
• Email: abearz@cro.it
• Phone: 0434-659294

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NXP900 with Lorlatinib in ALK-positive NSCLC

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• Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer

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• Lorlatinib with local consolidation therapy for ALK-positive advanced non-small cell lung cancer

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• Iruplinalkib for ALK-positive advanced lung adenocarcinoma after lorlatinib

  We will try iruplinalkib in adults with advanced ALK-positive lung adenocarcinoma who progressed on or couldn't tolerate lorlatinib to see how well it works and how safe it is in routine care.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.