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Monoclonal Antibodies

Daratumumab for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Sally Lau

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Participant must be ≥ 18 years of age and satisfy the legal age of consent in the jurisdiction in which the study is being conducted

Participant must have histologically or cytologically confirmed NSCLC that is metastatic or unresectable

Must not have

Participants with a history of chronic obstructive pulmonary disease (COPD) with grade ≥3 breathlessness on the modified medical research council (mMRC) dyspnea scale

Participant has a history of clinically significant cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of daratumumab on metastatic NSCLC patients with an STK11/LKB1 mutation. It will measure if a response rate of ≥20% is clinically meaningful.

Who is the study for?

Adults with metastatic or unresectable NSCLC and an STK11/LKB1 mutation, who have tried standard treatments like chemo, immunotherapy, and targeted therapy. They must be in good physical condition (ECOG 0-1), not pregnant or breastfeeding, able to consent, and meet specific health criteria. Excluded are those with significant heart disease, continuous oxygen needs, untreated brain metastases, other active cancers requiring treatment within the last 2 years.

What is being tested?

The trial is testing daratumumab's effectiveness for NSCLC patients with an STK11 mutation after previous treatments failed. It involves a single-arm study where all participants receive daratumumab at regular intervals until their disease progresses while being monitored as per usual care standards.

What are the potential side effects?

Daratumumab may cause side effects such as infusion reactions (symptoms that can occur during or after the drug is given), fatigue, nausea, bone marrow suppression (which can lead to low blood cell counts), and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years or older and legally able to consent.

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My lung cancer is confirmed and cannot be removed by surgery.

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My organs and bone marrow are functioning well.

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I am fully active or can carry out light work.

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My cancer has a known STK11/LKB1 mutation.

Exclusion Criteria

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

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I have severe breathlessness due to COPD.

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I have a history of serious heart problems.

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I do not have any uncontrolled illnesses that could interfere with the study.

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I am currently pregnant, breastfeeding, or planning to become pregnant soon.

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I have not fully recovered from a major surgery, or I have surgery planned during the study.

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My cancer has spread to the lining of my brain and spinal cord.

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I have brain metastases that have not been treated.

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I need to use oxygen all the time for a chronic condition.

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I have been treated with daratumumab before.

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I have had severe asthma in the last 2 years or currently have uncontrolled asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Response Rate (ORR) based on RECIST 1.1 Criteria

Secondary study objectives

Duration of Response (DoR)

Number of Adverse Events

Number of Adverse Events Attributed to Study Drugs

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with STK11/LKB1-Mutated NSCLCExperimental Treatment3 Interventions

Participants will receive daratumumab 1800mg and hyaluronidase 30,000 units (combined product DARZALEX Faspro) administered subcutaneously per the following dosing schedule: * Once per week for 8 administrations (Week 1-8) * Once every two weeks for 8 administrations (Week 9-16) * Once every 4 weeks until disease progression or unacceptable toxicity.

0 / 15Eligibility criteria met