Patritumab Deruxtecan for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+129 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Daiichi Sankyo

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called patritumab deruxtecan for patients with advanced lung cancer who have specific genetic mutations and have not responded to other treatments. The drug targets cancer cells specifically and delivers chemotherapy directly to them.

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer that has an EGFR mutation and has worsened despite previous treatments including an EGFR TKI and platinum-based chemotherapy. Participants must have good performance status, adequate organ function, no severe respiratory issues or uncontrolled diseases, and not be on high-dose steroids or immunosuppressants.

Inclusion Criteria

I have been treated with a platinum-based chemotherapy.

My recent tests show my organs and bone marrow are working well.

I am 18 years old or older.

+7 more

Exclusion Criteria

I have not had enough time between my last treatment and the start of this trial.

My cancer diagnosis includes small cell lung cancer, based on previous tissue tests.

I haven't had any other cancer besides this one in the last 3 years.

+10 more

Participant Groups

The study tests patritumab deruxtecan's effectiveness in two forms: a fixed dose and an up-titration method. It targets patients whose cancer progressed after at least one prior treatment regimen. The drug aims to inhibit tumor growth by targeting the HER3 protein present in some lung cancers.

2Treatment groups

Experimental Treatment

Group I: Study Group 2: Patritumab deruxtecan Up-TitrationExperimental Treatment1 Intervention

Study Group 2 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan up-titration IV every 3 weeks (Q3W)

Group II: Study Group 1: Patritumab deruxtecan 5.6 mg/kgExperimental Treatment1 Intervention

Study Group 1 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)