CompletedPhase 1

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

Japan78 participantsStarted 2021-08-06

Plain-language summary

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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Patients with severe complication
✕. Patients with multiple primary cancers

What they're measuring

Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）

Timeframe: 28 days

Adverse event (AE)

Timeframe: Up to 28 days after the last dose

Trial details

NCT IDNCT06525246

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-23

View on ClinicalTrials.gov More Stage IIIB Non-small Cell Lung Cancer trials