A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
1 other identifier
interventional
17
1 country
8
Brief Summary
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Nov 2018
Longer than P75 for early_phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2018
CompletedFirst Submitted
Initial submission to the registry
November 26, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2023
CompletedMay 15, 2025
November 1, 2022
4.6 years
November 26, 2018
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Overall response rate (partial and complete responses) of dacomitinib in participants with EGFR-mutant lung cancers and disease progression on osimertinib
1 year
Secondary Outcomes (2)
Progression-free survival
1 year
Overall survival
1 year
Study Arms (2)
Cohort 1: Participants treated with dacomitinib alone
EXPERIMENTALParticipants in this cohort have a somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy.
Cohort 2: Participants treated with dacomitinib in combination with osimertinib
EXPERIMENTALParticipants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation
Interventions
Cohort 1 Dacomitinib Dosing: Dose level 1: Dacomitinib 45mg daily Dose level -1: Dacomitinib 30mg daily Dose level -2: Dacomitinib 15mg daily Cohort 2 Dacomitinib Dosing: Dose level 1: Dacomitinib 30 mg daily Dose level -1: Dacomitinib 15 mg daily
In cohort 2, participants will begin on dacomitinib orally daily in combination with Osimertinib Dose level Osimertinib Dosing: Dose level 1: Osimertinib 80 mg daily Dose level -1: Osimertinib 40 mg daily
Eligibility Criteria
You may qualify if:
- Written informed consent
- Advanced biopsy-proven metastatic non-small cell lung cancer
- Somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy
- Prior treatment with osimertinib with response followed by disease progression
- No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)
- Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease progression on osimertinib prior to study initiation
- 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/mm3
- +2 more criteria
You may not qualify if:
- Pregnant or lactating women
- 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 Treatment
- Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).
- Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Yu, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2018
First Posted
November 27, 2018
Study Start
November 21, 2018
Primary Completion
July 7, 2023
Study Completion
July 7, 2023
Last Updated
May 15, 2025
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.