Triple-Drug cocktail targets tough lung cancer mutations
NCT ID NCT03567642
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This early-phase trial tests the safety of combining three drugs—osimertinib, a platinum chemotherapy (cisplatin or carboplatin), and etoposide—in people with metastatic EGFR mutant lung cancer that also has changes in the RB1 and TP53 genes. The goal is to find the highest safe dose and understand side effects. Participants have advanced non-small cell lung cancer and may be new to EGFR-targeted therapy or have started osimertinib within the past 9 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- osimertinib, platinum (cisplatin or carboplatin), and etoposide
- What this could lead to
- If successful, this combination could offer a new treatment option for people with a specific, hard-to-treat form of lung cancer.
- What could go wrong
- This is an early phase 1 trial with only 11 participants, so safety and dosing are still being determined. The combination may cause significant side effects or may not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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11 people
The number who actually took part.
- Started
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Jun 2018
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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