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Related Concept Videos

Treatment Resistant Cancers02:56

Treatment Resistant Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...

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PEARL: A Multicenter Phase 2 Study of Lorlatinib in Patients with ALK-Rearranged NSCLC and Central Nervous System

Chang Lu1, Hong-Hong Yan1, Chan-Yuan Zhang2

  • 1Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.

Clinical Lung Cancer
|December 25, 2024
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Lorlatinib shows promise for treating ALK-positive non-small cell lung cancer with brain metastases. This study evaluates its efficacy and safety using new CNS response criteria.

Keywords:
ALK TKIALK fusionCNS metastasesLeptomeningeal metastasesNon-small cell lung cancer

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Area of Science:

  • Oncology
  • Translational Research
  • Clinical Trials

Background:

  • Patients with ALK-rearranged non-small cell lung cancer (ALK+ NSCLC) and central nervous system (CNS) metastases often have poor performance status, limiting clinical trial participation.
  • There is a critical need for improved and validated assessment criteria for CNS response in ALK+ NSCLC.
  • Lorlatinib has demonstrated systemic activity in ALK+ NSCLC patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of lorlatinib in ALK+ NSCLC patients with progressive brain metastases (BM) and leptomeningeal metastases (LM).
  • To assess intracranial objective response rate (ORR) using refined CNS response evaluation criteria.
  • To conduct biomarker analyses for insights into response and resistance mechanisms.

Main Methods:

  • A multicenter, open-label, single-arm, prospective Phase II trial (PEARL study, CTONG2303).
  • Fifty eligible subjects divided into BM (n=30) and LM (n=20) cohorts.
  • Key inclusion criteria: ALK+ NSCLC, progressive CNS metastases, ECOG performance status 0-2 (BM) or 0-3 (LM).
  • Primary endpoint: Intracranial ORR per modified RECIST v1.1 (BM) and RANO-LM criteria (LM).

Main Results:

  • This section is not available in the provided abstract.

Conclusions:

  • The PEARL study will evaluate lorlatinib's efficacy in CNS metastases for ALK+ NSCLC.
  • Refined CNS response evaluation criteria will be utilized.
  • Biomarker analyses will offer insights into response and resistance mechanisms.