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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-12-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Adenocarcinoma Lung Cancer Lung Cancer Metastatic Lung Cancer Stage IV Recurrent Lung Adenocarcinoma Recurrent Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Trametinib 1.5mg + Erlotinib 75mg

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trametinib 1.5mg + Erlotinib 75mg

Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily or Trametinib 1.0mg + Erlotinib 100mg by mouth once daily.

Group Type EXPERIMENTAL

Trametinib

Intervention Type DRUG

Trametinib 1.5mg once daily by mouth

Erlotinib

Intervention Type DRUG

Erlotinib 75mg once daily by mouth

Interventions

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Trametinib

Trametinib 1.5mg once daily by mouth

Intervention Type DRUG

Erlotinib

Erlotinib 75mg once daily by mouth

Intervention Type DRUG

Eligibility Criteria

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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 \</= 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No