Status:
COMPLETED
A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief Summary
A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.
Detailed Description
Study design This is a phase II, open-label, single-arm tissue and plasma acquisition study assessing the efficacy, safety and underlying resistance mechanisms of osimertinib (80 mg orally, once daily...
Eligibility Criteria
Inclusion
- Provision of informed consent prior
- Patients aged 18 years or older
- Patients with histological confirmation of locally advanced or metastatic NSCLC
- Patients with M1 stage according to the Tumor, Node and Metastasis Classification of Malignant Tumours (TNM)
- Patients with an EGFR deletion or mutation known (from tumour biopsy or plasma) to be associated with EGFR TKI sensitivity
- Existence of measurable or evaluable disease (as per RECIST 1.1 criteria).
- Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumour or metastatic tumour tissue
- WHO performance status 0-1
- Life expectancy ≥12 weeks
- Capacity to swallow
- Patients able to complete study and within geographical proximity allowing for adequate follow up
- Resolution of all acute toxic effects of previous anticancer therapy
- Female patients must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential
- Male patients must be willing to use barrier contraception
Exclusion
- Locally advanced lung cancer candidate for curative treatment through radical surgery and/or radio(chemo)therapy
- Patients diagnosed with another lung cancer subtype
- Patients with an EGFR exon 20 insertion
- Patients with just one measurable or evaluable tumour lesion that has been resected or irradiated prior to their enrolment in the study
- Second active neoplasia
- Treatment with an investigational drug within five half-lives of the compound
- Participation in another clinical study with an investigational product (IP) during the last 3 weeks before the first day of study treatment
- Patients who have received prior immunotherapies
- Patients who have received prior EGFR treatments for lung cancer
- Patients who have received prior treatment with an EGFR TKI including in the adjuvant setting
- Patients who have received previous treatment for metastatic or stage IV disease
- Prior treatment with cytotoxic chemotherapy for advanced NSCLC
- Patients with a history of cancer that has been completely treated, with no evidence of malignant disease currently cannot be enrolled in the study if their chemotherapy was completed less than 6 months prior and/or have received a bone marrow transplant less than 2 years before the first day of study treatment
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or active infection (eg, patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled Hepatitis B virus (HBV) infection.
- Patients who have had a surgical procedure unrelated to the study within 14 days or major surgery within 1 month prior to the administration of the study drug
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis
- Any of the following cardiac criteria: Mean resting QT interval corrected for heart rate (QTc) more than 470 msec, obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, hypomagnesaemia, hypocalcaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
- Spinal cord compression, symptomatic and unstable brain metastases except for those patients who have completed definitive therapy, and have had a stable neurological status for at least 2 weeks after completion of definitive therapy. 20.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
- Inadequate bone marrow reserve or organ function 22.Female patients who are breastfeeding 23.Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome (CYP) 3A4.
- Patient unwilling to undergo a biopsy at the time of disease progression 25.History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib 26.Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements 27.Involvement in the planning and/or conduct of the study 28.Previous enrolment in the present study
Key Trial Info
Start Date :
May 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03239340
Start Date
May 30 2018
End Date
September 19 2023
Last Update
October 21 2024
Active Locations (26)
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1
Research Site
Athens, Georgia, United States, 30607
2
Research Site
Atlanta, Georgia, United States, 30307
3
Research Site
Boston, Massachusetts, United States, 02215
4
Research Site
Brescia, Italy, 25100