Triple-Drug cocktail targets tough lung cancer mutations

NCT ID NCT03567642

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

11 people

The number who actually took part.

Started

Jun 2018

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

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