A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib

Completed · Phase 2

Conditions studied: EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

In brief

A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.

Key facts

Study ID: NCT03239340
Run by: AstraZeneca
People needed: 154
Starts: 2018-05-30
Expected to finish: 2023-09-19
Last updated by the study team: 2024-10-21

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Athens, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Boston, Massachusetts, United States
Research Site — Brescia, Italy
Research Site — Meldola, Italy
Research Site — Monza, Italy
Research Site — Parma, Italy
Research Site — Roma, Italy
Research Site — Terni, Italy
Research Site — Johor Bahru, Malaysia
Research Site — Kuantan, Malaysia
Research Site — Kuching, Malaysia
Research Site — Lembah Pantai, Malaysia
Research Site — Pulau Pinang, Malaysia
Research Site — Busan, South Korea
Research Site — Cheongiu, South Korea
Research Site — Seongnam, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — A Coruña, Spain
Research Site — Barcelona, Spain
Research Site — Las Palmas de Gran Canaria, Spain
Research Site — Madrid, Spain

Full record on ClinicalTrials.gov

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