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Evaluation of Combination Checkpoint Inhibitor Plus Targeted Inhibitor (Erlotinib or Crizotinib) for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer: Phase Ib With Expansion Cohorts

Trial Profile

Evaluation of Combination Checkpoint Inhibitor Plus Targeted Inhibitor (Erlotinib or Crizotinib) for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer: Phase Ib With Expansion Cohorts

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

Most Recent Events

  • 30 Jul 2019 New trial record
  • 25 Jul 2019 According to results published in the Targeted Oncology Journal, treatment of the EGFR-mutated cohort with ipilimumab 3 mg/kg resulted in dose-limiting toxicity in three of eight patients due to grade 3 diarrhea.The study protocol was amended to accrue an additional six patients at a reduced dose of ipilimumab 1 mg/kg to better characterize the initial tolerated erlotinib dose as well as toxicity and treatment interaction.
  • 25 Jul 2019 According to results published in the Targeted Oncology Journal, this study was closed by the investigators and the data safety monitoring committee because of excessive short-term gastrointestinal toxicity caused by erlotinib plus ipilimumab after a total of 14 patients were enrolled (11 EGFR-mutated and three ALK-rearranged patients, pre-planned conventional definition of unacceptable toxicity frequency of 33%).

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