Status:
COMPLETED
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
EGFR Gene Mutation
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.
Eligibility Criteria
Inclusion
- 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
- Hemoglobin\>/=8.0 g/dL
- Platelets \>/=75,000/mm3
Exclusion
- 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
Key Trial Info
Start Date :
November 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03755102
Start Date
November 21 2018
End Date
July 7 2023
Last Update
May 15 2025
Active Locations (8)
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1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725