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A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

NCT03567642•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+8 more criteria

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
+3 more criteria

Locations (7)

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

Key Dates

Start Date

June 12, 2018

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

July 3, 2025

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

Osimertinib

DRUG

Platinum

DRUG

Etoposide

DRUG

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NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

Magnetic Resonance Imaging of the Lung: Oncological Applications

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance