Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 24
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years or older and legally able to consent.
Select...
My lung cancer is confirmed and cannot be removed by surgery.
Select...
My organs and bone marrow are functioning well.
Select...
I am fully active or can carry out light work.
Select...
My cancer has a known STK11/LKB1 mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) based on RECIST 1.1 Criteria
Secondary outcome measures
Duration of Response (DoR)
Number of Adverse Events
Number of Adverse Events Attributed to Study Drugs
+6 moreTrial 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.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,584 Total Patients Enrolled
Sally LauPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe breathlessness due to COPD.I am 18 years or older and legally able to consent.My lung cancer is confirmed and cannot be removed by surgery.My organs and bone marrow are functioning well.I have a history of serious heart problems.I have had cancer treatment within the specified timeframes.I do not have any uncontrolled illnesses that could interfere with the study.I am currently pregnant, breastfeeding, or planning to become pregnant soon.I have no active cancer other than the one being studied, or I've been cancer-free from another type for 2+ years.I have not fully recovered from a major surgery, or I have surgery planned during the study.My cancer has spread to the lining of my brain and spinal cord.You have a positive test for hepatitis B, hepatitis C, or other active infectious liver disease, or for HIV.My cancer progressed after treatments or I refused/can't have current treatments.I have brain metastases that have not been treated.I need to use oxygen all the time for a chronic condition.I have been treated with daratumumab before.I am fully active or can carry out light work.I have had severe asthma in the last 2 years or currently have uncontrolled asthma.I have not had a live vaccine close to starting the study treatment.My cancer has a known STK11/LKB1 mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with STK11/LKB1-Mutated NSCLC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the age limit of those eligible to enroll in this experiment?
"This particular medical trial is only open to individuals aged between 18 and 100. However, there are 43 different clinical trials that accept patients beneath the age of majority and 1901 studies targeting those 65 years or older."
Answered by AI
What are the criteria to qualify for this research project?
"Patients with non-small cell lung cancer aged 18 to 100 may apply for this medical trial. The total number of participants accepted will be 14 individuals."
Answered by AI
Is recruitment open for this research endeavor?
"Based on clinicaltrials.gov, this trial is not currently recruiting patients. It was first published on May 1st 2023 and the last update occurred March 29th 2023. Although this particular study is dormant at present, 1909 other trials are actively seeking participants across the world."
Answered by AI
To what extent are patients with STK11/LKB1-Mutated NSCLC at risk when undergoing treatment?
"Due to the Phase 2 nature of this clinical trial, meaning there is some data that supports safety but none for efficacy, our team at Power has assigned it a score of 2 out of 3 on the safety scale."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger