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Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer

Sponsored by Ono Pharmaceutical Co. Ltd

About this trial

Last updated 8 months ago

Study ID

ONO-7475-03

Status

Active, not recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
20+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation.

What are the participation requirements?

Yes

Inclusion 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

No

Exclusion Criteria

1. Patients with severe complication

2. Patients with multiple primary cancers