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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Osimertinib

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
• Total bilirubin
• Creatinine/= 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