A Pilot Study of Dacomitinib With or Without Osimertinib 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 15, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Early Phase 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Interventions being studied
- Drug: Dacomitinib; Drug: Osimertinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memorial Sloan Kettering Basking RidgeBasking Ridge, New Jersey
- Memorial Sloan Kettering MonmouthMiddletown, New Jersey
- Memorial Sloan Kettering BergenMontvale, New Jersey
- Memorial Sloan Kettering CommackCommack, New York
- Memorial Sloan Kettering WestchesterHarrison, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Memorial Sloan Kettering Rockville CentreRockville Centre, New York
- Memorial Sloan Kettering NassauUniondale, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 15, 2025. Always confirm current availability with the study team.