A sing le-arm, phase I study of ramucirumab in combination with erlotinib or osimertinib in previously untreated patients with EGFR mutantion-posit ive metastatic Non-small cell lung cancer with brain metastases

JRCT ID: jRCT2051190027

Registered date:21/06/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: lung carcinoma, non small cell
• Date of first enrollment: 17/09/2019
• Target sample size: 6
• Study type: Interventional
• Intervention(s): ramucirumab will be administered in combination with erlotinib or osimertinib

Outcome(s)

• Primary Outcome: Primary objective of the study is to assess the safety and tolerability of ramucirumab when administe red in combination with erlotinib or osimertinib. Safety and tolerability will be assessed based on th e DLT-evaluable population. The number of patients who experienced any DLT will be summarized.

Secondary Outcome

Toxicity profile
Objective Response Rate, ORR
Disease Control Rate, DCR
Response rate of intracranial lesions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: The study will enroll male or female patients, 20 years of age or older. Main inclusion criteria include: metastatic NSCLC patients with asymptomatic/incidental brain metastases who are eligible for first-line treatment with erlotinib or osimertinib based on previously documented evidence of tumors that have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, ECOG PS is 0-1.
• Exclude criteria: Key exclusion criteria include: patients with known T790M mutation; symptomatic CNS lesions; ophthalmologic abnormalities; active interstitial lung disease; and any prior systemic chemotherapy for advanced or metastatic NSCLC, including prior TKI therapy for any stage.

Related Information

• Primary Sponsor: Kaneda Hiroyasu
• Source(s) of Monetary Support: Eli Lilly Japan K.K.