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
Condition(s) studied
Investigational drug(s) / intervention(s)
Lorlatinib: 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.
Study 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
Primary outcome measure(s)
- Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib. — Up to 60 months
PFS defined as the time from study enrollment to the first documented disease progression or death due to any cause, whichever occurs first.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Azienda Ospedaliero-Universitaria di Parma | Parma | Italy | Not Yet Recruiting |
| Azienda Ospedaliera di Perugia | Perugia | Italy | Not Yet Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) | Udine | Italy | Not Yet Recruiting |
On this site
📄 Lorbrena (lorlatinib) drug profile →More Centro di Riferimento Oncologico - Aviano trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06378892 on ClinicalTrials.gov ↗ ← All trials in Italy