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Efficacy of osimertinib with Platinum and pemetrexed
in EGFR mutant non-small cell lung cancer patients bearing CNS metastasis,and have systemic progression but stable intracranial disease on OsimertiNib resistAnce.(EPONA)
(TORG1938 (EPONA Study))

TORG1938 (EPONA Study) (TORG1938 (EPONA Study))

Goto Yasushi

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo

ygoto-tky@umin.net

Goto Yasushi

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo

+81-3-3542-2511

ygoto-tky@umin.net

Recruiting

Sept. 01, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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.

Both

Advanced / recurrent non-small cell lung cancer (NSCLC)

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)

Progression-free survival

Overall survival, response rate, duration of CNS control, Time to treatment until WBRT, safety

+81-92-643-7171

July. 08, 2020

No

none