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Monoclonal Antibodies

Patritumab Deruxtecan for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Systemic therapy with at least 1 platinum-based chemotherapy regimen

Eastern Cooperative Oncology Group Performance Standard of 0 or 1 at Screening

Must not have

Inadequate washout period prior to Cycle 1 Day 1 for various treatments

Any previous histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up death date is collected until the participant discontinues the study or up to approximately 45 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of patritumab deruxtecan may include reactions related to infusion, fatigue, nausea, hair loss (alopecia), blood disorders like low platelet count or white blood cells leading to increased infection risk, as well as possible lung problems such as interstitial lung disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with a platinum-based chemotherapy.

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I am fully active or can carry out light work.

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My cancer has worsened despite the latest treatment.

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My cancer has a specific EGFR mutation.

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My lung cancer cannot be cured with surgery or radiation.

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I agree to provide the necessary tumor tissue for testing.

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I have at least one tumor that can be measured for its size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am taking more than 10 mg of prednisone or similar medication daily.

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I have active cancer spread to my brain or spinal cord.

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I still have side effects from cancer treatment that haven't improved.

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I do not have cancer spread to the lining of my brain and spinal cord.

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I have or might have a lung condition like pulmonary fibrosis.

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I do not have major heart problems before starting the treatment.

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I have been treated with HER3 antibody or topoisomerase I inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ death date is collected until the participant discontinues the study or up to approximately 45 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~death date is collected until the participant discontinues the study or up to approximately 45 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and death date is collected until the participant discontinues the study or up to approximately 45 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors

Disease Control Rate (DCR)

Duration of Response (DoR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

0 / 16Eligibility criteria met