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Tyrosine Kinase Inhibitor

Dacomitinib + Osimertinib 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

Ability to swallow oral medication

Somatic activating mutation in EGFR in a tumor biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test the safety of two drugs, dacomitinib and osimertinib, at increasing doses to see what effects, if any, this combination of drugs has on people with metastatic EGFR mutant lung cancer who have not been treated with an EGFR TKI.

Who is the study for?

This trial is for adults over 18 with advanced non-small cell lung cancer that has a specific EGFR mutation. They must not have had prior EGFR inhibitor treatments but can have other chemotherapies. Participants need to be in good physical condition, able to take oral meds, and willing to use birth control. People with recent surgeries or radiotherapy, significant heart issues, interstitial lung disease, uncontrolled side effects from past treatments, or certain ECG abnormalities cannot join.Check my eligibility

What is being tested?

The study tests the safety of combining two drugs—Dacomitinib and Osimertinib—at increasing doses on patients with metastatic EGFR mutant lung cancer who haven't been treated with an EGFR TKI before. The goal is to find out the effects of this drug combination.See study design

What are the potential side effects?

Potential side effects include diarrhea due to gastrointestinal reactions; liver function changes; blood disorders like low white blood cells, hemoglobin or platelets; potential heart rhythm problems (QTc prolongation); and possibly interstitial lung disease.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow pills.

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My tumor has a specific genetic change in the EGFR gene.

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My lung cancer has spread and was confirmed by a biopsy.

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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 have a tumor that can be measured and has not been treated with radiation.

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I am older than 18 years.

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My liver, kidney, and blood tests are within the required ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Best overall response rate

maximum tolerated dose

Side effects data

From 2022 Phase 4 trial • 101 Patients • NCT04511533

51%

Diarrhoea

43%

Rash

35%

Weight decreased

26%

Paronychia

25%

Dermatitis acneiform

11%

Stomatitis

11%

Mucosal inflammation

11%

Cough

10%

Decreased appetite

Anaemia

Mouth ulceration

Pyrexia

Back pain

Dyspnoea

Pruritus

Asthenia

Nausea

Chest pain

Hypokalaemia

Vomiting

Acute kidney injury

Death

COVID-19

Cardio-respiratory arrest

Blood creatinine increased

Disease progression

Fatigue

Cardiac arrest

COVID-19 pneumonia

Pneumonia viral

Sepsis

SARS-CoV-2 test positive

Skin toxicity

100%

80%

60%

40%

20%

Study treatment Arm

Dacomitinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dacomitinib and OsimertinibExperimental Treatment2 Interventions

Patients will begin on combination dacomitinib and osimertinib at the prescribed doses. A cycle will be 28 days in duration. The study will use a standard 3+3 dose escalation design. Per MD discretion, telemedicine visits may be utilized for cycles where imaging is not collected, and physical exam, vital sign and labs collection will only be required concurrent with imaging visits.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dacomitinib

2019

Completed Phase 4

~580

Osimertinib

2017

Completed Phase 4

~1010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,600 Total Patients Enrolled

Helena Yu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

10 Previous Clinical Trials

1,089 Total Patients Enrolled

Media Library

Dacomitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03810807 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Dacomitinib and Osimertinib

Non-Small Cell Lung Cancer Clinical Trial 2023: Dacomitinib Highlights & Side Effects. Trial Name: NCT03810807 — Phase 1

Dacomitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03810807 — Phase 1

Frequently Asked Questions

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

Has this experiment been undertaken previously?

"Initial trials of Dacomitinib, sponsored by AstraZeneca, began in 2013. After the successful completion of a phase 1 & 2 evaluation involving 603 participants, there are now 108 active studies located across 1062 cities and 51 countries worldwide."

Answered by AI

How many sites are currently hosting this experiment?

"Seven facilities are currently enrolling patients for this medical trial, including Memorial Sloan Kettering Westchester in Harrison and the New york and Commack locations of Memorial Sloan Kettering Cancer Center. Additionally, there are four additional sites across the United States participating."

Answered by AI

What is the recommended usage of Dacomitinib?

"Dacomitinib has been proven to be an effective treatment for point mutation in exon 21 (l858r), EGFR exon 19 deletion mutation, and non-small cell lung carcinoma (NSCLC)."

Answered by AI

Has Dacomitinib been subject to any prior clinical experiments?

"At present, there are 108 different studies that have been launched to evaluate Dacomitinib. Of those in progress, 17 are at stage 3. Despite the majority of these trials being situated around Guangzhou, Guangdong Province; a total of 4751 sites worldwide carry out clinical research for this therapy."

Answered by AI

Are there any negative consequences associated with Dacomitinib treatment?

"With limited data available to evaluate dacomitinib's safety and efficacy, our team at Power has estimated its risk rating as a 1."

Answered by AI

Is enrollment for this investigation open at the moment?

"As of this moment, the trial is not accepting any new participants. The first post was published on January 17th 2019 and the last update was made December 28 2021. For those seeking other studies, 1495 research projects are recruiting patients with lung cancer and 108 related to Dacomitinib require volunteers."

Answered by AI

What is the scope of participants for this research endeavor?

"Sadly, this study is no longer recruiting participants. The trial was initially posted on January 17th 2019 and the most recent update occured on December 28th 2021. If you're interested in other clinical trials, there are currently 1495 active lung cancer studies and 108 investigations actively enrolling patients for Dacomitinib treatment."

Answered by AI

Recent research and studies

Nature CommunicationsJournal

Identification of Optimal Dosing Schedules of Dacomitinib and Osimertinib for a Phase I/II Trial in Advanced Egfr-mutant Non-small Cell Lung Cancer

Poels, Kamrine E., Adam J. Schoenfeld, Alex Makhnin, Yosef Tobi, Yuli Wang, Heidie Frisco-Cabanos, Shaon Chakrabarti, et al.. 2021. “Identification of Optimal Dosing Schedules of Dacomitinib and Osimertinib for a Phase I/II Trial in Advanced Egfr-mutant Non-small Cell Lung Cancer”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-021-23912-4.

clinicaltrials.govStudy

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

2019. "Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03810807.