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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief 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

Official Title: A Multicenter Single-arm Phase II Interventional Study 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.

Study ID: NCT06378892

Interventions

Lorlatinib

Study Description

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.

Detailed Description: This is a multicentre, phase II, interventional, prospective, single arm, non-randomised study focused on ALK+ NSCLC with extracranial progression on Lorlatinib.Treatment phase include the period starting from cycle 1 day 1 visit to discontinuation of study therapy and consists of two phases: induction phase and maintenance phase. 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centro di Riferimento Oncologico (CRO) IRCCS, Aviano, , Italy

Azienda Ospedaliero-Universitaria Careggi Oncologia Medica, Firenze, , Italy

Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia, Lido Di Camaiore, , Italy

Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori", Meldola, , Italy

Fondazione IRCCS San Gerardo dei Tintori, Monza, , Italy

IOV Istituto Oncologico Veneto IRCCS, Padova, , Italy

Azienda Ospedaliero-Universitaria di Parma, Parma, , Italy

Azienda Ospedaliera di Perugia, Perugia, , Italy

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Udine, , Italy

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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