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Topoisomerase I inhibitors

Osimertinib + Chemotherapy for Lung Cancer

Phase 1

Waitlist Available

Led By Helena Yu, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA

Evidence of a concurrent RB1 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the safety of combining Osimertinib with Cisplatin or Carboplatin and Etoposide to treat EGFR mutant lung cancer.

Who is the study for?

This trial is for adults over 18 with advanced non-small cell lung cancer that has specific mutations (EGFR, RB1, P53). They should have good physical function and organ health, be able to swallow pills, and not have had certain treatments or surgeries recently. Pregnant women and those with small cell lung cancer are excluded.Check my eligibility

What is being tested?

The study tests the safety of Osimertinib combined with platinum-based drugs (Cisplatin or Carboplatin) and Etoposide in patients. It aims to find the best dose levels and see how this drug mix affects people with EGFR mutant lung cancers.See study design

What are the potential side effects?

Possible side effects include reactions related to liver function (elevated AST/ALT), kidney issues (creatinine changes), blood disorders like low neutrophil count or platelets, fatigue from anemia (low hemoglobin), digestive problems due to oral medication intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has a specific genetic change known as an EGFR mutation.

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My tests show a change in the RB1 gene in my cancer.

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I am willing to have more than one biopsy for my condition.

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I have a tumor that can be measured and hasn't been treated with radiation.

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I am able to care for myself but may not be able to do active work.

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I am older than 18 years.

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I can take pills by mouth.

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My liver, kidney, and blood counts meet the required levels for the trial.

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My cancer has a P53 mutation.

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I have advanced stage lung cancer that has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The MTD (maximum tolerated dose)

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551

10%

Blood creatine phosphokinase increased

10%

Fatigue

Decreased appetite

Diarrhoea

Cough

Mucosal inflammation

Rash

Pain in extremity

Constipation

Thrombocytopenia

Paronychia

Dyspnoea

Dengue fever

Disease progression

Cardio-respiratory arrest

Cataract

Mouth Ulceration

Deep Vein Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Osimertinib, Platinum (cisplatin or carboplatin) and EtoposideExperimental Treatment3 Interventions

Initially, 6 patients will be enrolled and will begin treatment with osimertinib 80mg orally daily (3 who will be receiving cisplatin and 3 who will be receiving carboplatin). Cisplatin or carboplatin treatment will be decided by the treating physician prior to study registration. After 9 weeks (+/- 1 week)( 3 cycles) on osimertinib alone, carboplatin or cisplatin and etoposide will be added. Carboplatin is doses at an AUC of 5 or cisplatin at 60mg/m2 will be given on C4D1. Etoposide is dosed at 100mg/m2 given on Days 1-3 of C4. Only patients on osimertinib 80mg orally daily at the start of cycle 4 will be included in the 3+3 dose de-escalation portion of the study. Chemotherapy and osimertinib will be administered concurrently during cycles 4-7, and from cycle 8 onward, osimertinib monotherapy will be continued. Patients will present every 2 cycles post-chemo (Cycles 8, 10, 12, etc.)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platinum

2008

Completed Phase 3

~430

Etoposide

2010

Completed Phase 3

~2440

Osimertinib

2017

Completed Phase 4

~1010

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,609 Total Patients Enrolled

Helena Yu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

10 Previous Clinical Trials

1,100 Total Patients Enrolled

Media Library

Etoposide (Topoisomerase I inhibitors) Clinical Trial Eligibility Overview. Trial Name: NCT03567642 — Phase 1

Lung Cancer Research Study Groups: Osimertinib, Platinum (cisplatin or carboplatin) and Etoposide

Lung Cancer Clinical Trial 2023: Etoposide Highlights & Side Effects. Trial Name: NCT03567642 — Phase 1

Etoposide (Topoisomerase I inhibitors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03567642 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions is Osimertinib commonly prescribed?

"Osimertinib is a common choice for treating prostate cancer and can also be utilized to treat other illnesses such as small cell lung cancer (sclc), metastatic thymic carcinoma, and acute myelocytic leukemia."

Answered by AI

Could you outline prior experiments conducted involving Osimertinib?

"Presently, there are 543 ongoing Osimertinib trials with 153 in the third phase. Houston, Texas is home to many of these studies; however, 36900 other sites across the world have clinical trials for this medication."

Answered by AI

Is Osimertinib a safe option for individuals seeking treatment?

"Our team at Power has assigned an initial safety rating of 1 to Osimertinib due to the limited amount evidence backing its efficacy and safety in a Phase 1 trial."

Answered by AI

Are there current opportunities to become involved in this research?

"According to clinicaltrials.gov, the trial is still open and accepting new participants. The initial posting date was June 12th 2018 with a recent update on July 1st 2022."

Answered by AI

What venues are currently hosting this experimental endeavor?

"This medical trial currently has 7 active recruitment sites, located in Uniondale and Commack, among others. Prospective patients are encouraged to pick the closest site to their residence in order to reduce travel demands if they decide to participate."

Answered by AI

How many participants are participating in this experiment?

"Affirmative, according to clinicaltrials.gov the current recruitment effort is ongoing since its initial posting on June 12th 2018. Currently, the trial requires 20 participants from 7 distinct medical centres for participation in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03567642.

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