A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib
The purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent lung adenocarcinoma that cannot be treated with curative intent.
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 Apr 2, 2024 · 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
- Phase 1 / Phase 2
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Interventions being studied
- Drug: Trametinib; Drug: Erlotinib
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.
- Pathologic evidence of advanced stage IV or recurrent lung adenocarcinoma reviewed at MSKCC
- Somatic activating mutation in EGFR Radiographic progression during treatment with erlotinib.
- Any number of prior chemotherapy regimens is permitted.
- Measurable (RECIST 1.1) indicator lesion not previously irradiated
- KPS \>/= 70%
- Age \>18 years old
- Must have undergone biopsy after development of acquired resistance to erlotinib with available archived tissue (equivalent of \> 10 unstained slides)
- Left ventricular Ejection Fraction \>/= the lower limit of normal by ECHO or MUGA
- Adequate organ function:
- AST, ALT \</= 2.5 x ULN
- Total bilirubin \</= 1.5 x ULN
- Albumin\>/=2.6g/dL - Creatinine \< 1.5 x ULN OR calculated creatinine clearance \>/=50mL/min
- Absolute neutrophil count (ANC) \>/= 1,200 cells/mm3
- Hemoglobin\>/=9.0 g/dL
- Platelets \>/=100,000/mm3
- Patients with symptomatic brain metastasis requiring escalating doses of steroids
- Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorption
- Pregnant or lactating women
- Any type of systemic therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol except for a EGFR TKI
- Patients who have received prior treatment with a MEK inhibitor
- Any major surgery or extensive radiotherapy within 21 days of starting treatment on protocol.
- A history of clinically significant interstitial lung disease or pneumonitis
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study administration, New York Heart Association Class III or IV congestive heart failure, or symptomatic uncontrolled Arrythmias, prolonged corrected QT interval \>480msec, treatment refractory hypertension, presence of a cardiac defibrillator
- History of central serous retinopathy or retinal vein occlusion
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey
- Memorial Sloan Kettering MonmouthMiddletown, New Jersey
- Memorial Sloan Kettering BergenMontvale, New Jersey
- Memorial Sloan Kettering CommackCommack, New York
- Memoral Sloan Kettering WestchesterHarrison, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Memorial Sloan Kettering NassauUniondale, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 2, 2024. Always confirm current availability with the study team.