Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA… (NCT05528458) | Clinical Trial Compass
RecruitingPhase 2
Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
South Korea59 participantsStarted 2022-09-11
Plain-language summary
This is an open label, phase II study to assess the efficacy of osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection for actionable EGFR mutation-positive stage IB-IIIA lung adenocarcinoma.
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provision of informed consent prior to any study specific procedures
✓. Adult male or female patients, aged from 30 to 75 years
✓. Pathologic proven lung adenocarcinoma with additional persistent GGNs in at least one other lobe: GGN is defined as a ground glass-opacity with well-defined margin, mean density above -500 HU and greater than 7.5 mm in its maximum diameter
✓. The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion.
✓. WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
✓. Complete surgical resection of the primary NSCLC is mandatory.
✓. Uneventful recovery from curative-intent lung cancer surgery
Exclusion criteria
✕. Regression of synchronous GGN after adjuvant chemotherapy prior to osimertinib
✕. Past history of postoperative ALI/ARDS or pneumonia during recovery period
✕. Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 week prior) (Appendix C). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
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What they're measuring
1
To assess the efficacy of osimertinib on the regression of additional GGN(s)
Timeframe: The imaging modalities used for GGN assessments will be CT scan (1 mm thin-section) of chest. Baseline, 12weeks, 24weeks, 36weeks, 52weeks and then every 24weeks until 5years assessments should be performed
. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
✕. 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.
✕. Any of the following cardiac criteria:
✕. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
✕. Inadequate bone marrow reserve or organ function (as demonstrated by any of the following laboratory values: