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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03567642

Enrollment

Registered

2018-06-26

Start date

2018-06-12

Completion date

2026-06-30

Last updated

2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Osimertinib, Platinum, Etoposide, EGFR Mutant, 18-211

Brief summary

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.

Interventions

DRUGOsimertinib

Osimertinib 80mg daily

DRUGPlatinum

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

DRUGEtoposide

Etoposide 100mg/m2 or Etoposide 80mg/m2

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The MTD (maximum tolerated dose)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026