Status:
COMPLETED
Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Metastatic Non-small Cell Lung Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic EGFR muta...
Eligibility Criteria
Inclusion
- Written informed consent
- Advanced biopsy-proven metastatic non-small cell lung cancer
- Somatic activating mutation in EGFR in a tumor biopsy
- No prior EGFR inhibitor treatment (gefitinib, afatinib, erlotinib, dacomitinib, osimertinib) however, prior treatment with other chemotherapies are allowed
- Archival tissue available from a pre-treatment tumor biopsy or willing to undergo a tumor biopsy 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
- Agree to use effective methods of contraception from the time of screening until 3 months after treatment discontinuation (for males and females of child-bearing potential)
- 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/mm\^3
- Hemoglobin≥9.0 g/dL
- Platelets ≥100,000/mm\^3
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
- A mean QTc \>470ms (Fridericia"s correction), clinically important arrhythmia, conduction or morphology of resting ECG (eg complete LBBB, 1st -3rd degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmia)
- Cardiovascular disease or cerebrovascular disease, CVA or MI \< 6 months prior to study enrollment, unstable angina, NYHA \>Grade II CHF, or serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment
- History of pneumonitis or interstitial lung disease (ILD), drug induced ILD, radiation pneumonitits that required steroid treatment, and any evidence of clinically active ILD
- Serious chronic GI conditions associated with diarrhea
- Symptomatic, unstable brain metastases requiring escalating doses of steroids
- Continue to have unresolved \> CTCAE grade 1 toxicity from any previous treatment
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03810807
Start Date
January 17 2019
End Date
December 15 2025
Last Update
December 23 2025
Active Locations (7)
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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