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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506714-43-00
Enrollment
45
Registered
2024-02-26
Start date
2024-03-15
Completion date
Unknown
Last updated
2025-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALK positive Non-Small Cell Lung Cancer

Brief summary

PFS defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first

Detailed description

intracranial PFS defined as time from randomization until CNS disease progression or death from any cause, OS is defined as the time from randomization until death from any cause, Frequency and severity of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Patient reported NSCLC specific QoL as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire: - Core 30 (QLQ-C30): Questionnaire consisting of 30 measuring subjects’ general cancer symptoms and functioning - 13-item Lung Cancer (QLQ-LC13) module: A complementary questionnaire measuring lung cancer symptoms and side-effects from conventional chemo- and radiotherapy

Interventions

Sponsors

Centro Di Riferimento Oncologico Di Aviano
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PFS defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first

Secondary

MeasureTime frame
intracranial PFS defined as time from randomization until CNS disease progression or death from any cause, OS is defined as the time from randomization until death from any cause, Frequency and severity of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Patient reported NSCLC specific QoL as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire: - Core 30 (QLQ-C30): Questionnaire consisting of 30 measuring subjects’ general cancer symptoms and functioning - 13-item Lung Cancer (QLQ-LC13) module: A complementary questionnaire measuring lung cancer symptoms and side-effects from conventional chemo- and radiotherapy

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026