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A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755102
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.

Condition or disease Intervention/treatment Phase
EGFR Gene Mutation Lung Cancer Lung Cancer Metastatic Drug: Dacomitinib Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metastatic EGFR-Mutant Lung Cancer with evidence of C797S Drug: Dacomitinib
Dacomitinib (45mg) administered as a once daily dose (irrespective of food intake). Concomitant use of proton pump inhibitors with dacomitinib should be avoided if possible, and if necessary, dosing timing should be spaced apart (morning and evening).

Experimental: Metastatic EGFR-Mutant Lung Cancer with no evidence of C797S Drug: Dacomitinib
Dacomitinib (45mg) administered as a once daily dose (irrespective of food intake). Concomitant use of proton pump inhibitors with dacomitinib should be avoided if possible, and if necessary, dosing timing should be spaced apart (morning and evening).




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 1 year ]
    Overall response rate (partial and complete responses) of dacomitinib in participants with EGFR-mutant lung cancers and disease progression on osimertinib


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year ]
  2. Overall survival [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Advanced biopsy-proven metastatic non-small cell lung cancer
  • Somatic activating mutation in EGFR in a tumor 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 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
    • Hemoglobin>/=8.0 g/dL
    • Platelets >/=75,000/mm3

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755102


Contacts
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Contact: Helen Yu, MD 646-888-4274 YuH@mskcc.org
Contact: Mark Kris, MD 646-888-4205 krism@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Helen Yu, MD    646-888-4274      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Helen Yu, MD    646-888-4274      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Helen Yu, MD    646-888-4274      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Helen Yu, MD    646-888-4274      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Helen Yu, MD    646-888-4274      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Helen Yu, MD    646-888-4274      
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Helen Tu, MD    646-888-4274      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Helena Yu, MD    646-888-4274      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Helen Yu, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03755102    
Other Study ID Numbers: 18-341
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
EGFR C797S
EGFR mutant lung cancer
dacomitinib
osimertinib
18-341
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases