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
Qualifiers
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
Treatments tested in this trial
- Osimertinib 80 MG
Treatment groups
43 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov