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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
Must not have
Any radiotherapy within 1 week of starting treatment on protocol
Any evidence of active clinically significant interstitial lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had any radiation therapy in the week before starting the treatment.
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I have an active lung condition that affects the tissue and space around the air sacs.
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I still have noticeable side effects from past treatments.
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My cancer is purely small cell type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The MTD (maximum tolerated dose)
Side effects data
From 2020 Phase 4 trial • 60 Patients • NCT0385355110%
Blood creatine phosphokinase increased
10%
Fatigue
8%
Decreased appetite
8%
Diarrhoea
8%
Cough
7%
Mucosal inflammation
7%
Rash
7%
Pain in extremity
7%
Constipation
7%
Thrombocytopenia
7%
Paronychia
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2016
Completed Phase 3
~440
Etoposide
2010
Completed Phase 3
~2960
Osimertinib
2017
Completed Phase 4
~1120
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,510 Total Patients Enrolled
Helena Yu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
1,100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a specific genetic change known as an EGFR mutation.I have either not started EGFR TKI treatment or began osimertinib less than 9 weeks ago.My tests show a change in the RB1 gene in my cancer.I am willing to have more than one biopsy for my condition.I have a tumor that can be measured and hasn't been treated with radiation.I am able to care for myself but may not be able to do active work.I am older than 18 years.I have not had any radiation therapy in the week before starting the treatment.I have not had major surgery within the last week.I have an active lung condition that affects the tissue and space around the air sacs.I do not have severe kidney issues, hearing loss needing a device, or severe nerve pain, and my doctor agrees I can receive cisplatin.I can take pills by mouth.My liver, kidney, and blood counts meet the required levels for the trial.I started an EGFR inhibitor treatment over 9 weeks ago, not including osimertinib.I still have noticeable side effects from past treatments.My cancer has a P53 mutation.My cancer is purely small cell type.I have advanced stage lung cancer that has spread.Your heart's electrical activity, measured by an EKG test, shows abnormal patterns or a prolonged QT interval.
Research Study Groups:
This trial has the following groups:- Group 1: Osimertinib, Platinum (cisplatin or carboplatin) and Etoposide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.