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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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.
Centro di Riferimento Oncologico (CRO) IRCCS
Aviano, Italy
RECRUITINGAzienda Ospedaliero-Universitaria Careggi Oncologia Medica
Florence, Italy
NOT_YET_RECRUITINGAzienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia
Lido di Camaiore, Italy
NOT_YET_RECRUITINGIstituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori"
Meldola, Italy
NOT_YET_RECRUITINGFondazione IRCCS San Gerardo dei Tintori
Monza, Italy
NOT_YET_RECRUITINGIOV Istituto Oncologico Veneto IRCCS
Padua, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero-Universitaria di Parma
Parma, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera di Perugia
Perugia, Italy
NOT_YET_RECRUITINGAzienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine, Italy
NOT_YET_RECRUITINGCompare 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.
PFS defined as the time from study enrollment to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 60 months
Intracranial Progression Free Survival (PFS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib.
Intracranial PFS defined as time from study enrollment until CNS disease progression or death from any cause.
Time frame: Up to 60 months
Overall survival (OS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib progression
OS is defined as the time from study enrollment until death from any cause.
Time frame: Up to 60 months
Describe the safety of PT/pem-based chemotherapy plus Lorlatinib combination
Frequency and severity of adverse events graded according to the CTCAE version 5.0.
Time frame: Up to 60 months
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