ONO-7475-03 : ONO-7475 Phase 1 Study

JRCT ID: jRCT2051210045

Registered date:02/07/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: EGFR mutated, stage IIIB/IIIC/IV or recurrent, NSCLC, which is unsuitable for radical irradiation
• Date of first enrollment: 06/08/2021
• Target sample size: 75
• Study type: Interventional
• Intervention(s): Administration of ONO-7475 with Osimertinib

Outcome(s)

• Primary Outcome: Tolerability, safety

Key inclusion & exclusion criteria

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

Include criteria

1. Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation
2. Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib
3. Patient has an ECOG performance status of 0-1

Exclude criteria

1. Patients with severe complication
2. Patients with multiple primary cancers

Related Information

• Primary Sponsor: Hirashima Yoshinori
• Secondary ID(s): NCT06525246