Lung Cancer Clinical Trial
Official title:
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.
Verified date | November 2022 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.
Status | Completed |
Enrollment | 17 |
Est. completion date | July 7, 2023 |
Est. primary completion date | July 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Basking Ridge | Basking Ridge | 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 Monmouth | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen | Montvale | New Jersey |
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 |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Progression-free survival | 1 year | ||
Secondary | Overall survival | 1 year |
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