A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/4/2018
Start Date:March 1, 2017
End Date:March 2020
Contact:Helena Yu, MD
Email:yuh@mskcc.org
Phone:646-888-4274

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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.


Inclusion Criteria:

- 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
- Total bilirubin
- 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

Exclusion Criteria:

- 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
We found this trial at
7
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Basking Ridge, New Jersey
Phone: 646-888-4274
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Commack, New York 11725
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Harrison, New York
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Middletown, New Jersey 07748
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225 Summit Avenue
Montvale, New Jersey 07645
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4274
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Rockville Centre, New York 11570
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Rockville Centre, NY
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