A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers

Running, not enrolling · Phase 1

Conditions studied: Lung Cancer

In brief

The purpose of this study is to test the safety of combining Osimertinib with either Cisplatin or Carboplatin (at different dose levels) and Etoposide, to find out what effects, if any, this combination of drugs has on people with EGFR mutant lung cancer.

Key facts

Study ID

NCT03567642

Run by

Memorial Sloan Kettering Cancer Center

People needed

11

Starts

2018-06-12

Expected to finish

2027-06-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Advanced biopsy-proven metastatic non-small cell lung cancer
• Either have not started an EGFR TKI or may have started osimertinib within the last 9 weeks
• Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA
• Evidence of a concurrent P53 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA
• Evidence of a concurrent RB1 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA
• Must have a site of disease amenable to repeat biopsy and be willing to undergo a biopsy during treatment
• Measurable (RECIST 1.1) indicator lesion not previously irradiated
• Karnofsky performance status (KPS) ≥ 70%
• Age >18 years old
• Ability to swallow oral medication
• Adequate organ function
• AST, ALT ≤ 3 x ULN
• Total bilirubin ≤ 1.5x ULN
• Creatinine ≤ 1.5x ULN OR calculated creatinine clearance ≥ 60ml/min
• Absolute neutrophil count (ANC) ≥ 1000 cells/mm\^3
• Hemoglobin≥8.0 g/dL
• Platelets ≥100,000/mm\^3

You may not qualify if…

• Pregnant or lactating women
• Started an EGFR TKI other than osimertinib or started osimertinib more than 9 weeks ago
• Any radiotherapy within 1 week of starting treatment on protocol.
• Any major surgery within 1 weeks of starting treatment on protocol.
• Any evidence of active clinically significant interstitial lung disease
• Continue to have unresolved > grade 1 toxicity from any previous treatment
• Have pure small cell histology
• Corrected QT interval using Fridericia's formula (QTcF)>475msec or any clinically significant (as deemed by the investigator) abnormalities in rhythm or conduction or morphology of the resting EKG.
• Patients are to be excluded from cisplatin treatment arm if they meet any of the following criteria:
• Creatinine clearance < 60 ml/min
• Hearing impairment requiring assistive device
• Neuropathy
• The treating provider does not feel as though the patient should receive cisplatin

Where it is running

• Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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