Clinical trial · Interventional
A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib
NCT03076164CI-TRIAL-00075621completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Metastatic | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Lung Cancer Stage IV | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Lung Adenocarcinoma | Lung Adenocarcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trametinib 1.5mg + Erlotinib 75mg
- description
- 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.
- interventionNames
- Drug: Trametinib
- Drug: Erlotinib
Primary outcomes (2)
- measure
- Participants Response Rate
- timeFrame
- 2 years
- description
- Response and progression of disease will be evaluated in this study using interval imaging every 8 weeks with CT scan of the chest and imaging of any other target lesion with response evaluated by RECIST 1.1.
- measure
- Number of Participants Evaluated for Toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.