Your session is about to expire
← Back to Search
Immunostimulant
Combination Immunotherapy for Lung Cancer
Phase 2 & 3
Waitlist Available
Led By John M Wrangle
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization
Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g. EGFR, ALK gene fusions, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing immunotherapy treatment with N-803 and pembrolizumab for advanced non-small cell lung cancer. N-803 may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has spread and who have already tried certain FDA-approved therapies. They must have normal liver function or slightly elevated levels if they have liver metastases, no severe neurological issues from brain metastases, and should not be on high doses of steroids. Participants need to show progression after one line of anti-PD-1 or anti-PD-L1 therapy and be able to receive standard care treatments.Check my eligibility
What is being tested?
The study tests a combination immunotherapy treatment using N-803 (ALT-803) plus Pembrolizumab against the usual treatment for advanced non-small cell lung cancer. It aims to see if this combo can activate natural killer cells in the immune system to fight cancer more effectively than current methods.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, skin rashes, fatigue, potential blood disorders, and an increased risk of infections due to immune response alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain or spinal metastases have been treated and are stable for over a week.
Select...
I have a specific mutation in my lung cancer and have tried at least one approved treatment for it.
Select...
My bilirubin levels are within the normal range, or up to 5 times the limit if I have liver metastases.
Select...
I've had one treatment with anti-PD-1 or anti-PD-L1 for advanced cancer and my cancer got worse during or after treatment.
Select...
I can safely receive standard cancer treatment options.
Select...
My liver enzymes are within the required range for the study.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer can be seen on scans and has been checked recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Duration of response (DoR)
Investigator-assessed progression-free survival (IA-PFS)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (pembrolizumab, nogapendekin alfa)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa SC on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (standard of care)Active Control7 Interventions
Patients receive standard of care consisting of docetaxel IV over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,088 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,729 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,585 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your immune system has enough white blood cells called neutrophils.I am not pregnant or nursing and will use birth control during and 4 months after the study.My lung cancer has worsened after the latest treatment.My brain or spinal metastases have been treated and are stable for over a week.Your blood platelet count is at least 100,000 per microliter within the last 28 days before joining the study.I have a specific mutation in my lung cancer and have tried at least one approved treatment for it.I do not need and am not planning to receive brain or spinal cord disease treatment during the first cycle of the study.I am not planning to receive any other cancer treatments while on this study.I haven't had severe immune system side effects, except for a mild rash.My bilirubin levels are within the normal range, or up to 5 times the limit if I have liver metastases.I have not had radiation therapy in the last 14 days.Your kidney function is normal, and a recent blood test shows that your kidneys are working well.I haven't had chemotherapy, immunotherapy, or experimental drugs in the last 3 weeks.Your hemoglobin level is at least 9 grams per deciliter within the last 28 days before joining the study.I can safely receive standard cancer treatment options.I have not received treatments like ipilimumab or other immune therapies.My liver enzymes are within the required range for the study.I am fully active or restricted in physically strenuous activity but can do light work.I do not have another cancer that could affect this treatment's safety or results.I do not have severe liver problems or fluid buildup in my abdomen due to liver disease.I haven't taken high-dose steroids or immunosuppressants in the last 7 days.I have no lasting nerve issues from spinal or brain cancer, and if I'm on steroids, it's a low dose.I haven't had a heart attack or stroke in the last 6 months.I haven't had major surgery in the last 14 days and have recovered from any past surgeries.I do not have severe heart disease or recent heart attacks.I have never needed steroids for lung inflammation not caused by an infection.I've had one treatment with anti-PD-1 or anti-PD-L1 for advanced cancer and my cancer got worse during or after treatment.I haven't taken medication for an autoimmune disease in the last two years.I have recovered from previous treatment side effects, except for hair loss.I have HIV, am on treatment, and my last viral load was undetectable.You do not have a history of a weak immune system since birth.I have had a brain scan within the last 42 days.I haven't had a live vaccine in the last 28 days.My cancer can be seen on scans and has been checked recently.I haven't taken nitrosoureas or mitomycin-c in the last 42 days.I have never had an organ transplant requiring immunosuppressants.I had a physical exam within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (pembrolizumab, nogapendekin alfa)
- Group 2: Arm A (standard of care)
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.
How many test subjects are enrolled in this experiment?
"Yes, the information on ClinicalTrials.gov indicates that this trial is actively seeking candidates. The clinical trial was initially posted on 2/15/2022 and was most recently updated on 10/18/2022. The clinical trial is enrolling 478 patients across 100 sites in order to test the efficacy of the proposed intervention."
Answered by AI
Is this study still admitting new participants?
"Yes, this is an ongoing clinical trial that was first posted on February 15th, 2022. The last update to the study's information occurred on October 18th, 2022."
Answered by AI
Could you please inform me as to how many hospitals are currently conducting this experiment?
"One hundred clinical trial sites are currently participating in this study, which includes locations in Columbus, Steubenville and Greenville. To help reduce the burden on participants, it is advised to select a site that is close to your home."
Answered by AI
Pembrolizumab is most commonly used to treat what condition?
"Pembrolizumab is indicated for the treatment of metastatic cutaneous squamous cell carcinoma. Additionally, this drug has shown efficacy in treating melanoma, malignant melanoma of skin, and recurrent cervical cancer."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Virginia
Other
California
What site did they apply to?
Kaiser Permanente-San Francisco
Kaiser Permanente-Vallejo
Kaiser Permanente-Gaithersburg Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger