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

Plain-language summary

This study examines the combined use of the drugs ONO-7475 and Osimertinib in patients with EGFR gene mutation-positive non-small cell lung cancer. It enrolled patients with a confirmed EGFR exon 19 deletion or L858R mutation who were scheduled to receive Osimertinib. It was conducted in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Ono Pharmaceutical Co., Ltd.

Intervention

ONO-7475, Osimertinib Mesylate

Start date

8/6/2021

Estimated completion

6/23/2025

Countries

Japan

Related genes

Locations

• Matsuyama, Japan
• Kobe, Japan
• Nishinomiya, Japan
• Sagamihara-shi, Japan
• Yokohama, Japan
• Ina, Japan
• Kyoto, Japan
• Niigata, Japan
• Osaka, Japan
• Takatsuki, Japan
• Nagaizumi-chō, Japan
• Koto-Ku, Japan
• Shinjuku-Ku, Japan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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

Exclusion Criteria:

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