19 Participants Needed

Immunotherapy + Radiation for Advanced Non-Small Cell Lung Cancer

(IRRADIATE-Lung Trial)

Vamsidhar Velcheti, MD profile photo
Overseen ByVamsidhar Velcheti, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to test if low dose radiation, which is routinely used in treating patients with lung cancer for symptom control, can improve the results from the standard treatment with pembrolizumab and chemotherapy. In this study, only individuals who have NSCLC that is advanced (Stage IV), or has come back (recurred), will be able to participate.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or any form of immunosuppressive therapy, you must stop these at least 7 days before starting the trial treatment.

Is the combination of immunotherapy and radiation generally safe for humans?

Pembrolizumab (Keytruda), an immunotherapy drug, can cause immune-related side effects like pneumonitis (lung inflammation) and type 1 diabetes in a small percentage of patients. Common side effects include fatigue, cough, and nausea, while more serious effects can affect various body systems and may be worsened by infections.12345

How is the treatment of Immunotherapy + Radiation for Advanced Non-Small Cell Lung Cancer different from other treatments?

This treatment combines pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells, with radiation, which directly targets and kills cancer cells. This combination is unique because it leverages both the body's immune response and direct cancer cell destruction, potentially offering a more comprehensive approach than traditional chemotherapy alone.13678

What data supports the effectiveness of the treatment for advanced non-small cell lung cancer?

Research shows that pembrolizumab, a drug used in the treatment, has significantly improved outcomes in patients with advanced non-small cell lung cancer, especially when combined with radiation therapy. It has been approved by the FDA for certain types of lung cancer, demonstrating better survival rates compared to traditional chemotherapy.367910

Who Is on the Research Team?

Vamsidhar Velcheti, MD | NYU Langone Health

Vamsidhar Velcheti, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with advanced Stage IV NSCLC who haven't had systemic therapy before. Participants need at least one measurable lung lesion outside the radiation field, must not be pregnant or breastfeeding, and agree to use contraception. They can't join if they have active infections, other cancers needing treatment, certain autoimmune diseases, a history of severe allergies to pembrolizumab components, or are on immunosuppressants.

Inclusion Criteria

My recent tests show my organs are functioning well.
I have at least 2 large, measurable cancer spread sites, with one not treated by radiation.
You have a disease that can be measured using a specific medical guideline.
See 8 more

Exclusion Criteria

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
I have been diagnosed with HIV.
I have not had radiation in the same area where I am now planning to have it.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive non-ablative focal radiation therapy to up to five distinct metastatic subsites

1 week
5 visits (in-person)

Treatment

Participants receive chemotherapy with pembrolizumab for up to 6 cycles

18 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks
Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Chemotherapy
  • Pembrolizumab
  • Radiation
Trial Overview The study tests whether low dose radiation alongside standard pembrolizumab (an immunotherapy drug) and chemotherapy improves outcomes in advanced lung cancer patients. It's designed for those with untreated Stage IV NSCLC to see if symptom control through radiation can boost the effectiveness of these treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Untreated Patients With Stage IV NSCLCExperimental Treatment3 Interventions

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Chemotherapy for:
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Approved in United States as Chemotherapy for:
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Approved in Canada as Chemotherapy for:
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Approved in Japan as Chemotherapy for:
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Approved in China as Chemotherapy for:
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Approved in Switzerland as Chemotherapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

A case study of a 52-year-old man with HIV and lung adenocarcinoma showed that combining pembrolizumab with stereotactic body radiotherapy led to serious immune-related adverse events, including massive pericardial effusion and interstitial pneumonia.
Despite initial treatment with pembrolizumab and radiotherapy, the patient's condition worsened, highlighting the need for caution and further clinical trials to assess the safety and efficacy of this combination therapy in HIV-infected patients.
Pembrolizumab combined with stereotactic body radiotherapy in a patient with human immunodeficiency virus and advanced non-small cell lung cancer: a case report.Li, D., He, C., Xia, Y., et al.[2018]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]

Citations

Pembrolizumab combined with stereotactic body radiotherapy in a patient with human immunodeficiency virus and advanced non-small cell lung cancer: a case report. [2018]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. [2022]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Retrospective analysis of clinical trial safety data for pembrolizumab reveals the effect of co-occurring infections on immune-related adverse events. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Selective Personalized Radioimmunotherapy for Locally Advanced Non-Small-Cell Lung Cancer Trial. [2023]
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