Global Study on Osimertinib for Patients with Early-Stage EGFR-Mutated Non-Small Cell Lung Cancer After Tumor Removal

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05120349

Provider View

This international clinical trial is evaluating the effects of the drug osimertinib in patients with early-stage non-small cell lung cancer (NSCLC) that has specific EGFR mutations, following the complete surgical removal of their tumor.

Patient Parameters

Program Overview

The study aims to determine how effective and safe osimertinib is as an additional treatment for patients with early-stage non-small cell lung cancer (NSCLC) that has specific EGFR mutations, after they have had their tumor completely removed through surgery.

Description

This is a Phase III study, which means it is in the later stages of testing. It is a double-blind, randomized, placebo-controlled trial, meaning neither the participants nor the researchers know who is receiving the actual drug or a placebo. The study involves two groups: one group will receive the drug osimertinib, and the other will receive a placebo, which looks like the drug but has no active ingredients. Participants will be randomly assigned to one of these groups.

The focus is on patients with early-stage (IA2-IA3) non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene, which are known to respond well to EGFR-targeted treatments. These mutations include Ex19del and L858R. All participants must have had their tumor completely removed by surgery before joining the study.

Participants will take either osimertinib or a placebo once daily for up to three years, unless they meet criteria to stop the treatment earlier. The study will monitor the effectiveness of osimertinib in preventing cancer from returning and assess any side effects experienced by participants.

Eligibility Criteria

Inclusion Criteria

  1. Male or female, at least ≥ 18 years.
  2. NSCLC, of non-squamous histology.
  3. Stage IA2 or IA3 disease, based on TNM8 classification.
  4. Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection.
  5. Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
  6. World Health Organization performance status of 0 or 1.
  7. Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
  8. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.
  9. Minimum life expectancy of > 6 months.
  10. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception.

Exclusion Criteria

  1. Mixed small cell and non-small cell cancer history.

  2. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection.

  3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including HCV and HIV or active uncontrolled HBV infection.

  4. History of another primary malignancy, including any known or suspected synchronous primary lung cancer except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.

  5. Any of the following cardiac criteria:

    • Mean resting QTcF interval > 470 ms, obtained from triplicate ECGs performed at screening.
    • Any abnormalities in rhythm, conduction, or morphology of resting ECG,
    • Any factors that increase the risk of QTcF prolongation or risk of arrhythmic events.

  6. History of interstitial lung disease.

  7. Inadequate bone marrow reserve or organ function.

  8. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.

  9. Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).

  10. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.

  11. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.

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