A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
- Conditions
- EGFR Gene MutationLung Cancer MetastaticLung Cancer
- Interventions
- Registration Number
- NCT03755102
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
-
Written informed consent
-
Advanced biopsy-proven metastatic non-small cell lung cancer
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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)
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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
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Karnofsky performance status (KPS) >/= 70%
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Age >/= 18 years old
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Ability to swallow oral medication
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Participants treated with dacomitinib alone Dacomitinib Participants 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 Dacomitinib Participants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation Cohort 2: Participants treated with dacomitinib in combination with osimertinib Osimertinib Participants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation
- Primary Outcome Measures
Name Time Method Overall Response Rate 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
Name Time Method Progression-free survival 1 year Overall survival 1 year
Trial Locations
- Locations (8)
Memorial Sloan Kettering Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Rockville Centre
🇺🇸Rockville Centre, New York, United States
Memorial Sloan Kettering Nassau
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering Basking Ridge🇺🇸Basking Ridge, New Jersey, United States