NCT03567642Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 13 Jun 2018
- Start date
- 12 Jun 2018
- Primary completion date
- Jun 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Lung cancer
- NCT number
- NCT03567642
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 11
- From 12 Jun 2018 to the primary completion date, Jun 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any radiotherapy within 1 week of starting treatment on protocol.
- Any major surgery within 1 weeks of starting treatment on protocol.
- Continue to have unresolved \> grade 1 toxicity from any previous treatment
Other illness
- Any evidence of active clinically significant interstitial lung disease
- Hearing impairment requiring assistive device
Lab values
- Started an EGFR TKI other than osimertinib or started osimertinib more than 9 weeks ago
- 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.
- Creatinine clearance \< 60 ml/min
Other
- Pregnant or lactating women
- Have pure small cell histology
- Patients are to be excluded from cisplatin treatment arm if they meet any of the following criteria:
- Neuropathy
- The treating provider does not feel as though the patient should receive cisplatin
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.