Uncommon EGFR mutations conducted with Osimertinib in patients with NSCLC: A phase 2 study

JRCT ID: jRCTs071200002

Registered date:08/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Advanced / recurrent non-small cell lung cancer (NSCLC)
• Date of first enrollment: 08/04/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Continue administration of Osimertinib 80mg/day until meeting the withdrawal criteria of this study.

Outcome(s)

• Primary Outcome: Response Rate
• Secondary Outcome: Disease control rate, progression free survival, time to treatment failure, overall survival, duration of response, safety (rate of adverse events)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with non-squamous non-small cell lung cancer (either of adenocarcinoma, large cell carcinoma (excluding large-cell neuroendocrine carcinoma), and non-small cell lung cancer that histological type is cannot be specified) confirmed by histological or cytological diagnosis.
2) Patients with palliative-intent therapy with stage IIIB/IIIC/V, or post-operative recurrence.
3) Patients who are diagnosed as uncommon EGFR mutation with molecular diagnosis using biopsy specimen, surgical specimen, or blood specimen.
4) Performance status (ECOG): 0-2.
5) Patient is more than and equal to 20 years of age at enrollment date.
6) Patients have measurable lesion according to RECIST criteria version 1.1.
7) Patients without symptomatic brain metastasis, leptomeningeal carcinomatosis, and spinal metastasis requiring radiation therapy and surgical procedure.
8) Patients who have not treated with previous systemic chemotherapy or radical chest radiotherapy for other cancers. However, patients treated with adjuvant chemotherapy or radiotherapy for complete resected NSCLC are eligible if more than and equal to 12 weeks passed after the final treatment date. In addition, operation and hormone therapy for other cancers are eligible.
9) Patients without finding of interstitial pneumonia and pulmonary fibrosis by chest CT imaging.

Exclude criteria

1)Patients with treatment history of systemic chemotherapy for NSCLC (including EGFR inhibitors).
2)Patients with interstitial lung disease (ILD) in chest X-ray image or pneumonitis. Patients with treatment history of interstitial pneumonia other than infection are also excluded.
3)Patients with active double cancer.
4)Patients with complication of unstable angina (angina pectoris occurs or aggravates within three weeks) or patients who have anamnesis of myocardial infarction within six months.
5)Patients with any factors that increase the risk of QTc interval prolongation in ECG or the risk of arrhythmic events such as electrolyte imbalance.
6)Patients with active mutation alone (exon 19 in-del or exon 21 L858R), exon 20 insertion mutation alone, and patients with de novo T790M only.
7)Patient with other driver mutations (ALK fusion gene, ROS1 fusion gene, BRAF, etc).
8)Patients with hypersensitivity history to either of chemical structure similar to osimertinib or same class drugs or its excipients.

Related Information

• Primary Sponsor: Kubota Kaoru
• Source(s) of Monetary Support: AstraZeneca K.K.