NCT06378892View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2028

Conditions
Non Small Cell Lung Cancer MetastaticALK Gene Mutation
Interventions
DRUG

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.

Trial Locations (9)

20900

NOT_YET_RECRUITING

Fondazione IRCCS San Gerardo dei Tintori, Monza

33010

NOT_YET_RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Udine

33081

RECRUITING

Centro di Riferimento Oncologico (CRO) IRCCS, Aviano

35128

NOT_YET_RECRUITING

IOV Istituto Oncologico Veneto IRCCS, Padua

43126

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria di Parma, Parma

47014

NOT_YET_RECRUITING

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

50134

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Careggi Oncologia Medica, Florence

55049

NOT_YET_RECRUITING

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

06129

NOT_YET_RECRUITING

Azienda Ospedaliera di Perugia, Perugia

All Listed Sponsors
lead

Centro di Riferimento Oncologico - Aviano

OTHER