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

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.

Trial Details

NCT ID
NCT06378892
Phase
PHASE2
Sponsor
Centro di Riferimento Oncologico - Aviano
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Lorlatinib
Locations (sample)
  • Aviano, Italy|46.07056,12.59472
  • Florence, Italy|43.77925,11.24626
  • Lido di Camaiore, Italy|43.90012,10.2269
  • Meldola, Italy|44.12775,12.0626
  • Monza, Italy|45.58005,9.27246

Key Eligibility 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…
  • Age at the time of signing the informed consent at least 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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