Phase 2
N=17
A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03434418 ↗Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Oct 2023
Primary outcome: Primary: Objective Response Rate as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- osimertinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) |
8 | — |
| SECONDARY Progression Free Survival (PFS) as Measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) |
10.5 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 |
13; 9; 7; 7; 6; 5 | — |
| SECONDARY Overall Survival as Noted by Follow-up Via Composite of Telephone or Medical Record Review. |
13.8 | — |
Summary
This is a research study to find out if a drug called, osimertinib, is safe and effective in treating advanced Non-Small Cell Lung Cancer (NSCLC) by targeting the treatment of epidermal growth factor receptor (EGFR) mutation exon 18 G719X, exon 20 S7681, or exon 21 L861Q. Patients on the study will not have had previous tyrosine kinase inhibitor (TKI) treatment.
Eligibility Criteria
Inclusion Criteria
- EGFR mutations as performed on a CLIA certified laboratory demonstrating EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q. Patients with compound (also referred to as multiple mutations) will be eligible provided the NSCLC demonstrates one of these mutations).
- Histological or cytological confirmation diagnosis of Stage 4 NSCLC.
- Measurable disease by RECIST 1.1 (please refer to appendix 4)
- The following laboratory values obtained ≤ 14 days prior to study initiation.
- Hematology: ANC ≥ 1, 500 / ml, platelet count, ≥ 100,000 / ml, hemoglobin ≥ 9.0 g / dl
- Hepatic: ALT or ALT 14 days have elapsed from completion of radiotherapy and patient is neurologically stable as assessed by treating physician).
- Malabsorption syndrome, refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
- Detection of concurrent EGFR mutation with exon 20 T790M, exon 19 deletion, exon 21 L858R mutation or exon 20 insertion. Patients with compound (also referred to as multiple mutations) will be excluded if the molecular testing includes one of these mutations.
- Active pregnancy or breast-feeding: Pregnant women are excluded from this study because the effects of osimertinib on the development of the fetus are unknown, and there is potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with osimertinib, breastfeeding should be discontinued if the mother is treated with these agents.
- Grade ≥ 2 blurred vision, conjunctivitis, corneal ulcer, dry eye, or keratitis
Data sourced from ClinicalTrials.gov (NCT03434418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.