Apply to Trial

Compensation: Varies

Number of Visits: 11

Duration: 18 weeks

Immunotherapy + Radiation for Advanced Non-Small Cell Lung Cancer
(IRRADIATE-Lung Trial)

Overseen ByVamsidhar Velcheti, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Immunodeficiency, Active TB, Autoimmune, others

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?

This trial explores whether adding low-dose radiation to the standard treatment of pembrolizumab (a type of immunotherapy) and chemotherapy can enhance outcomes for people with advanced non-small cell lung cancer (NSCLC). It focuses on those whose cancer has spread or returned. Participants must have metastatic NSCLC and not have received previous systemic therapy. The study aims to improve treatment effectiveness by combining therapies. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pembrolizumab, when combined with chemotherapy, is generally well-tolerated by patients with advanced non-small cell lung cancer (NSCLC). Many studies have demonstrated significant benefits from this combination. Specifically, data from several trials confirm pembrolizumab's safety and effectiveness in treating advanced NSCLC.

Additionally, research examining pembrolizumab with radiation therapy found this combination safe and potentially effective for patients. While all treatments can have side effects, existing research suggests that pembrolizumab, along with chemotherapy and radiation, remains a safe option, especially with close monitoring for adverse effects.

Overall, previous studies have shown promising safety results when combining pembrolizumab with chemotherapy and low-dose radiation. This supports its use in treating advanced lung cancer and offers hope for those considering joining clinical trials.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about combining immunotherapy with radiation for advanced non-small cell lung cancer (NSCLC) because it offers a new approach to tackling the disease. While standard treatments usually involve chemotherapy alone, this method uses pembrolizumab, an immunotherapy drug, alongside radiation. Pembrolizumab works by boosting the body's immune system to better detect and attack cancer cells. The addition of radiation may enhance this effect, potentially leading to more effective tumor reduction. This combination could provide a more powerful treatment option for patients with advanced NSCLC.

What evidence suggests that this trial's treatments could be effective for advanced non-small cell lung cancer?

Research has shown that pembrolizumab, when combined with chemotherapy, greatly benefits people with advanced non-small cell lung cancer (NSCLC). Specifically, studies found that about 19% of patients lived for five years after receiving this treatment, a significant improvement over chemotherapy alone. In this trial, participants will receive radiation alongside chemotherapy and pembrolizumab. Combining pembrolizumab with radiation has strengthened the body's immune response against tumors. Several trials have confirmed pembrolizumab's effectiveness in treating advanced NSCLC. These findings suggest that adding radiation could enhance the treatment's success.² ³ ⁶ ⁷ ⁸

Who Is on the Research Team?

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

Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.

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

Approved in European Union as Chemotherapy for:

Breast cancer
Metastatic breast cancer
Various other cancers

Approved in United States as Chemotherapy for:

Breast cancer
Metastatic breast cancer
Various other cancers

Approved in Canada as Chemotherapy for:

Breast cancer
Metastatic breast cancer
Various other cancers

Approved in Japan as Chemotherapy for:

Breast cancer
Metastatic breast cancer
Various other cancers

Approved in China as Chemotherapy for:

Breast cancer
Metastatic breast cancer
Various other cancers

Approved in Switzerland as Chemotherapy for:

Breast cancer
Metastatic breast cancer
Various other cancers

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]

Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.

In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus.Clotman, K., Janssens, K., Specenier, P., et al.[2022]

Citations

1.merck.commerck.com/news/five-year-data-for-mercks-keytruda-pembrolizumab-plus-chemotherapy-showed-sustained-survival-benefit-versus-chemotherapy-alone-in-two-studies-for-metastatic-non-small-cell-lung-cancer-nsclc/

Five-Year Data for Merck's KEYTRUDA® (pembrolizumab ...Five-year overall survival rate of 19.4% and 18.4% for KEYTRUDA plus chemotherapy in KEYNOTE-189 and KEYNOTE-407, respectively.

2.nature.comnature.com/articles/s43018-025-01018-w

Combination of pembrolizumab and radiotherapy induces ...Combination of pembrolizumab and radiotherapy induces systemic antitumor immune responses in immunologically cold non-small cell lung cancer.

3.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC9942927/

Effectiveness and safety of pembrolizumab for patients with ...Several randomized controlled trials (RCTs) have confirmed the favorable clinical benefit of pembrolizumab in advanced non-small cell lung cancer (NSCLC).

4.clinicaltrials.govclinicaltrials.gov/study/NCT01295827

NCT01295827 | Study of Pembrolizumab (MK-3475) in ...The study will investigate the safety, tolerability, and efficacy of pembrolizumab (2 mg/kg and 10 mg/kg) in participants with advanced or metastatic MEL.

5.keytruda.comkeytruda.com/non-small-cell-lung-cancer/clinical-trial-results/

Non–Small Cell Lung Cancer - Clinical Trial ResultsView the clinical trial results for this treatment option for certain people with non–small cell lung cancer.

6.clinicaltrials.govclinicaltrials.gov/study/NCT03924869

NCT03924869 | Efficacy and Safety Study of Stereotactic ...The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult ...

7.sciencedirect.comsciencedirect.com/science/article/pii/S1470204525004620

Articles Radiotherapy-free pembrolizumab combined with ...Radiotherapy-free pembrolizumab combined with chemotherapy for locally advanced non-small-cell lung cancer with PD-L1 tumour proportion score of ...

8.clinicaltrials.govclinicaltrials.gov/study/NCT03425643

NCT03425643 | Efficacy and Safety of Pembrolizumab (MK ...This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) ...

Other People Viewed

By Subject

By Trial