Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT03755102
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03755102
Study Brief:
Protocol Section:
NCT03755102