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Completed

NCT Number: NCT03755102

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

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

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Key information

Conditions

EGFR Gene Mutation Lung Cancer Lung Cancer Metastatic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dacomitinib

Drug

Cohort 1 Dacomitinib Dosing:

Dose level 1: Dacomitinib 45mg daily Dose level -1: Dacomitinib 30mg daily Dose level -2: Dacomitinib 15mg daily

Cohort 2 Dacomitinib Dosing:

Dose level 1: Dacomitinib 30 mg daily Dose level -1: Dacomitinib 15 mg daily

Osimertinib

Drug

In cohort 2, participants will begin on dacomitinib orally daily in combination with Osimertinib

Dose level Osimertinib Dosing:

Dose level 1: Osimertinib 80 mg daily Dose level -1: Osimertinib 40 mg daily

Primary outcomes

  1. Overall Response Rate

    Time frame: 1 year

    Overall response rate (partial and complete responses) of dacomitinib in participants with EGFR-mutant lung cancers and disease progression on osimertinib

Secondary outcomes

  1. Progression-free survival

    Time frame: 1 year

  2. Overall survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 27, 2018
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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