Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-75
SponsorSamsung Medical Center
About this trial
This study designed 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 I lung adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of informed consent prior to any study specific procedures
Adult male or female patients, aged from 30 to 75 years
Pathologic proven stage I 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.
Disqualifiers
Treatment with any neoadjuvant therapy (radiation, any cytotoxic chemotherapy, investigational agents or other anticancer drugs after surgery) before randomization
Treatment with any adjuvant therapy (any cytotoxic chemotherapy, investigational agents or other anticancer drugs after surgery) before randomization
Extensive surgery other than lobectomy or sublobar resection (i.e. bilobectomy, sleeve lobectomy, pneumonectomy)
Past history of postoperative ALI/ARDS or pneumonia during recovery period
Trial design
Design model
Parallel
Treatments tested in this trial
Osimertinib 80 MG
DrugOsimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR-TKI sensitising and resistance mutations in NSCLC with a significant selectivity margin over wild-type EGFR. Osimertinib will be administered orally as one 80 mg tablet once a day (1 cycle is 28 days). Cycles are repeated until disease progression, unacceptable toxicity, or until 1 year after the initiation of osimertinib administration.
Treatment groups
43 Participants
are divided into 2 treatment groupsGroup A: OsemertinibActive comparator 1 intervention
Group B: ObservationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
To assess the efficacy of osimertinib on the regression of additional GGN(s)
Regression rate of additional GGNs using investigator assessments by comparing the size of GGN(s) on the initial CT scan (at randomization) to that in the last follow-up scan. We will conduct the quantitative analysis of GGNs on the initial and follow-up CT scans via VOI (Volume of Interest) segmentation. VOI is measured with the unit of mm3.
Time frame
up to 12monthsSecondary outcomes
1
To assess the efficacy of osimertinib in avoidance of subsequent anticancer treatments including surgery or radiation for GGN(s)
Avoidance rate of subsequent surgeries or radiation treatments for GGN(s) within one year since the initiation of osimertinib treatment: Defined as the number (percent) of patients who do not require subsequent anticancer treatments including surgeries or radiation for remaining GGN(s) within one year since the initiation of osimertinib treatment
Time frame
up to 12months2
To evaluate when GGN(s) will regress after osimertinib treatment
Time to regression: Defined as the length of time from the date of initiation of osimertinib treatment to the first date of GGN regression
Time frame
up to 12months3
To evaluate the rate of treatment failure
Incidence of regrowth and reappearance of remaining GGN(s) within one year since the initiation of osimertinib treatment
Time frame
up to 12months4
To evaluate the number of patients with new nodules
Number of patients who would have growing new nodules (either ground glass nodules or solid nodules) with high suggestion of lung cancer by lung-special radiologists within one year since the initiation of Osimertinib treatment
Time frame
up to 12monthsSponsors and contacts
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Source ClinicalTrials.gov