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

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Recurrent Non-Small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; EGFR Mutation-Related Tumors; Stage IIIC Non-Small Cell Lung Cancer

Treatments: Drug: Osimertinib Mesylate; Drug: ONO-7475

Study type: Interventional

Funder types: Industry

Identifiers

NCT06525246

ONO-7475-03

Details and patient eligibility

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.

Enrollment: 78 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

ONO-7475+Osimertinib

Experimental group

Treatment:

Drug: ONO-7475

Drug: Osimertinib Mesylate