A Study of Dacomitinib in Patients With Metastatic EGFR Mutant Lung Cancer Previously Treated With Osimertinib



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/29/2018
Start Date:November 21, 2018
End Date:November 2019
Contact:Helen Yu, MD
Email:YuH@mskcc.org
Phone:646-888-4274

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A Pilot Study of Dacomitinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib

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


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
- Total bilirubin
- Creatinine /= 60ml/min

- Absolute neutrophil count (ANC) >/= 1000 cells/mm3

- Hemoglobin>/=8.0 g/dL

- Platelets >/=100,000/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
We found this trial at
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 646-888-4274
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
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Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Harrison, New York
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480 Red Hill Road
Middletown, New Jersey 07748
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4274
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1000 North Village Avenue
Rockville Centre, New York 11570
Phone: 646-888-4274
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