A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedosimertinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 17, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Duke University

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Duke University
Interventions being studied: Drug: osimertinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

EGFR→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 \< 2.5 times ULN if no demonstrable liver metastases or \<5 times ULN in the presence of liver metastases
Total bilirubin \< 1.5 times ULN if no liver metastases or \< 3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases
Renal: Cockcroft-Gault calculated creatinine clearance of ≥ 45 ml/min or creatinine ≤1.5 x ULN
Have normal QT interval on ECG evaluation QT corrected of ≤ 450 ms in males or ≤ 470 ms in females obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine-derived QTc value
Cardiac ejection fraction of ≥ 45%
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
Negative pregnancy test done ≤7 days (or per institutional policy) prior to treatment, for women of childbearing potential only. Female must use highly effective contraceptive measures, and must have a negative pregnancy test or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
Male subjects must be willing to use barrier contraception
Age ≥ 18 years
Provision of written informed consent prior to any study-specific procedures

Reasons someone may not be able to joinExclusion criteria

Prior therapy with EGFR TKI therapy
Greater than 2 lines of prior systemic therapy for metastatic non-small cell lung cancer.
Any cytotoxic chemotherapy or other anticancer drugs from previous treatment regimen or clinical study within 14 days of first dose of study drug.
Treatment with an investigational drug within 5 half-lives of the compound
Other active malignancy ≤ 2 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, patients must not be receiving other specific treatment (i.e. hormonal therapy) for their cancer
Prior radiotherapy ≤ 14 days
Untreated symptomatic brain metastases (treated brain metastases are allowed provided \> 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Duke University Medical CenterDurham, North Carolina
The Ohio State University Medical CenterColumbus, Ohio
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 17, 2023. Always confirm current availability with the study team.

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