Clinical Trials /

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

NCT03810807

Description:

The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic EGFR mutant lung cancer that has not been treated with an EGFR TKI.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer
  • Official Title: Phase 1 Study of Combination Dacomitinib and Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers

Clinical Trial IDs

  • ORG STUDY ID: 18-411
  • NCT ID: NCT03810807

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
Dacomitinib and OsimertinibDacomitinib and Osimertinib

Purpose

The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic EGFR mutant lung cancer that has not been treated with an EGFR TKI.

Trial Arms

NameTypeDescriptionInterventions
Dacomitinib and OsimertinibExperimentalPatients will begin on combination dacomitinib and osimertinib at the prescribed doses. A cycle will be 28 days in duration. The study will use a standard 3+3 dose escalation design.
  • Dacomitinib and Osimertinib

Eligibility Criteria

        Inclusion Criteria:

          -  Written informed consent

          -  Advanced biopsy-proven metastatic non-small cell lung cancer

          -  Somatic activating mutation in EGFR in a tumor biopsy

          -  No prior EGFR inhibitor treatment (gefitinib, afatinib, erlotinib, dacomitinib,
             osimertinib) however, prior treatment with other chemotherapies are allowed

          -  Archival tissue available from a pre-treatment tumor biopsy or willing to undergo a
             tumor biopsy 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

          -  Agree to use effective methods of contraception from the time of screening until 3
             months after treatment discontinuation (for males and females of child-bearing
             potential)

          -  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/mm^3

               -  Hemoglobin≥9.0 g/dL

               -  Platelets ≥100,000/mm^3

        Exclusion Criteria:

          -  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

          -  A mean QTc >470ms (Fridericia‟s correction), clinically important arrhythmia,
             conduction or morphology of resting ECG (eg complete LBBB, 1st -3rd degree heart
             block, any factors that increase the risk of QTc prolongation or risk of arrhythmia)

          -  Cardiovascular disease or cerebrovascular disease, CVA or MI < 6 months prior to study
             enrollment, unstable angina, NYHA >Grade II CHF, or serious cardiac arrhythmia
             uncontrolled by medication or with the potential to interfere with protocol treatment

          -  History of pneumonitis or interstitial lung disease (ILD), drug induced ILD, radiation
             pneumonitits that required steroid treatment, and any evidence of clinically active
             ILD

          -  Serious chronic GI conditions associated with diarrhea

          -  Symptomatic, unstable brain metastases requiring escalating doses of steroids

          -  Continue to have unresolved > CTCAE grade 1 toxicity from any previous treatment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:maximum tolerated dose
Time Frame:1 year
Safety Issue:
Description:The MTD will be defined as the highest dose at which not more than 1/6 of the patients experience dose limiting toxicity (DLT). DLT is defined as any of the toxicity events described below that occurs within cycle 1 of treatment with the combination of dacomitinib and osimertinib.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Dacomitinib
  • Osimertinib
  • EGFR Mutant Lung Cancers
  • 18-411

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