TORG1938 (EPONA Study)

JRCT ID: jRCTs071200029

Registered date:01/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced / recurrent non-small cell lung cancer (NSCLC)
• Date of first enrollment: 13/10/2020
• Target sample size: 92
• Study type: Interventional

Intervention(s)

Randomize the two treatment groups.
A group (CBDCA AUC 5 or Cisplatin 75mg/m^2 + PEM 500mg/m^2)
B group (CBDCA AUC 5 or Cisplatin 75mg/m^2 + PEM 500mg/m^2 + Osimertinib 80mg/day)

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall survival, response rate, duration of CNS control, Time to treatment until WBRT, safety

Key inclusion & exclusion criteria

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

Include criteria

1. Patients having non-squamous non-small cell lung cancer confirmed by histological or cytological diagnosis.
2. Patients with brain metastases who treated with palliative-intent therapy stage IV or postoperative recurrence.
3. Patients who had been diagnosed as having an EGFR mutations in any of biopsy, surgical, or blood specimens(plasma), cytology, pleural fluid, or cellblock specimens before the treatment with Osimertinib.
4. Patients treated with Osimertinib for more than 32 weeks.
5. Patients were PD or clinically exacerbated after obtaining an overall effect of CR/PR/SD with Osimertinib, but who did not show any increase in brain metastatic lesions in size throughout the period of Osimertinib administration.
6. Patients have measurable lesion(s) according to the RECIST criteria version 1.1. However, the criteria for measurable lesions do not need to be met for CNS lesions found by baseline image evaluation.
7. patients with no evidence of interstitial pneumonia or pulmonary fibrosis on chest radiographs at the time of enrollment.

Exclude criteria

1. Patients having uncontrolled complications or CTCAE Grade >= 2 adverse events at the time of enrollment. Excludes alopecia and neuropathy related to platinum agents of Grade 2 or lower. If the complications are stable due to oral medication or insulin preparations including hypertension or diabetes, the reaseachers can enroll to the trial.
2. Patients having a previous history of interstitial lung disease (ILD) or ILD due to EGFR inhibitor on radiography at the time of registration.Patients with radiation pneumonitis requiring steroids or with a history of clinically active interstitial lung disease.
3. Patients with intractable nausea and vomiting who cannot take prescribed medication. Also, patients with chronic gastrointestinal disorders or bowel resection that may interfere with the appropriate absorption of Osimertinib.
4. Patients having 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 the ECG or the risk of arrhythmic events including electrolyte imbalance.

Related Information

• Primary Sponsor: Goto Yasushi
• Source(s) of Monetary Support: AstraZeneca K.K.