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NCT Number: NCT03567642

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Osimertinib

Drug

Osimertinib 80mg daily

Platinum

Drug

Cisplatin 60mg/m2 or Cisplatin 45mg/m2 Carboplatin AUC 5 or Carboplatin AUC 4

etoposide

Drug

Etoposide 100mg/m2 or Etoposide 80mg/m2

Primary outcomes

  1. The MTD (maximum tolerated dose)

    Time frame: 2 years

    Determine the safety and toxicity profile of combination osimertinib, platinum (cisplatin or carboplatin), etoposide for patients with metastatic EGFR mutant lung cancers with concurrent RB1 and TP53 alterations.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Phase 1 Study of Combination Osimertinib, Platinum, Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers With Concurrent RB1 and TP53 Alterations

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2018
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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