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



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:June 12, 2018
End Date:June 2020
Contact:Helena Yu, MD
Email:yuh@mskcc.org
Phone:646-888-4274

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

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.


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 6
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 6 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

- QTc>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
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