Clinical Trials /

A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.

NCT03755102

Description:

The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.

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

Recruiting

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT03755102

Trial Eligibility

Document

Title

  • Brief Title: A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
  • Official Title: A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.

Clinical Trial IDs

  • ORG STUDY ID: 18-341
  • NCT ID: NCT03755102

Conditions

  • EGFR Gene Mutation
  • Lung Cancer
  • Lung Cancer Metastatic

Interventions

DrugSynonymsArms
DacomitinibCohort 1: Participants treated with dacomitinib alone
OsimertinibCohort 2: Participants treated with dacomitinib in combination with osimertinib

Purpose

The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1: Participants treated with dacomitinib aloneExperimentalParticipants in this cohort have a somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy.
  • Dacomitinib
Cohort 2: Participants treated with dacomitinib in combination with osimertinibExperimentalParticipants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation
  • Dacomitinib
  • 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 or plasma cfDNA liquid biopsy

          -  Prior treatment with osimertinib with response followed by disease progression

          -  No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib,
             erlotinib)

          -  Archival tissue available from a tumor biopsy done after disease progression on
             osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease
             progression on osimertinib 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

          -  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/mm3

               -  Hemoglobin>/=8.0 g/dL

               -  Platelets >/=75,000/mm3

        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

          -  Continue to have unresolved > grade 1 toxicity from any previous treatment Treatment

          -  Patients with a known mechanism of resistance to osimertinib that will clearly not
             respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).

          -  Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of
             steroids
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate
Time Frame:1 year
Safety Issue:
Description:Overall response rate (partial and complete responses) of dacomitinib in participants with EGFR-mutant lung cancers and disease progression on osimertinib

Secondary Outcome Measures

Measure:Progression-free survival
Time Frame:1 year
Safety Issue:
Description:
Measure:Overall survival
Time Frame:1 year
Safety Issue:
Description:

Details

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

Trial Keywords

  • EGFR C797S
  • EGFR mutant lung cancer
  • dacomitinib
  • osimertinib
  • 18-341
  • Memorial Sloan Kettering Cancer Center

Last Updated

February 17, 2021