Immunotherapy + Radiotherapy for Lung Cancer

(REVIVE Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Chicago
Must be taking: Anti-PD-1, Anti-PD-L1
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 the effectiveness of combining immunotherapy (which helps the body's immune system fight cancer) and radiotherapy (radiation treatment) for individuals with non-small cell lung cancer that has spread or returned after treatment. The researchers aim to determine if this combination is more effective than standard chemotherapy options. Participants will receive either immunotherapy with radiation or the standard chemotherapy treatment selected by the investigator. This trial suits those with non-small cell lung cancer that has progressed after one prior immunotherapy treatment and can be targeted with radiation. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

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

The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

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

A previous study revealed important safety findings for patients receiving a combination of immunotherapy and radiotherapy for lung cancer. Most patients tolerated cemiplimab well, with some experiencing mild to moderate side effects like tiredness and skin reactions.

Durvalumab, often used in lung cancer treatments, is generally well-tolerated. Some patients reported manageable side effects such as coughing and fatigue.

Research indicates that the combination of ipilimumab and nivolumab, while effective, can cause more noticeable side effects in some individuals, including skin rash and diarrhea, which require careful monitoring.

Pembrolizumab has undergone extensive study and is approved for use in other cancers. It is generally well-tolerated, though some patients report mild effects like muscle aches and loss of appetite.

Each of these treatments has shown a range of side effects, mostly mild to moderate. As these treatments are still under study, researchers continue to learn about their safety and effectiveness.

Why are researchers excited about this trial's treatments?

Researchers are excited about combining immunotherapy with radiotherapy for lung cancer treatment because it offers a fresh approach to tackling the disease. While most standard treatments, like chemotherapy, aim to kill cancer cells directly, immunotherapy works differently by boosting the body's own immune system to recognize and attack cancer cells. Combining this with radiotherapy, which uses targeted radiation to damage cancer cell DNA, could enhance the overall effectiveness and potentially lead to better outcomes. This dual approach aims to not only shrink tumors but also prevent them from coming back, offering hope for improved survival rates.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research shows that combining immunotherapy with radiotherapy may help treat lung cancer. In this trial, one group of participants will receive a combination of radiotherapy and immunotherapy, which may include drugs like nivolumab and ipilimumab. Studies have found that using nivolumab and ipilimumab together can help patients with non-small cell lung cancer (NSCLC) live longer compared to traditional chemotherapy. Another study found that using the drug cemiplimab alone also improved survival for patients with a specific type of NSCLC. Meanwhile, another group will receive standard chemotherapy. Real-world evidence suggests these treatments could be a good option for advanced lung cancer. Overall, these treatments show promising results in helping patients live longer and enjoy long-term benefits.12345

Are You a Good Fit for This Trial?

This trial is for adults with metastatic or recurrent non-small cell lung cancer whose disease has worsened after previous immunotherapy. Participants must have at least one measurable tumor that can be treated with focused radiation and still be eligible for standard chemo or immunotherapy.

Inclusion Criteria

I meet the required criteria for previous or current treatments.
I am receiving only one type of treatment for my condition.
My disease can be treated with standard immunotherapy or chemotherapy.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard immunotherapy with radiation or standard chemotherapy

48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ablative Hypofractionated Radiotherapy
  • Cemiplimab
  • Docetaxel
  • Durvalumab
  • Gemcitabine
  • Ipilimumab plus Nivolumab
  • Pembrolizumab
  • Ramucirumab

Trial Overview

The study tests combining immunotherapy drugs (like pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab) with targeted high-dose radiotherapy. Some patients may also receive chemotherapy based on doctor’s choice. Treatments are assigned according to current guidelines.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Radiotherapy (RT) + ImmunotherapyExperimental Treatment2 Interventions
Group II: Standard Chemotherapy (Investigator's Choice")Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38175294/

Real-world outcomes of nivolumab plus ipilimumab and ...

Conclusions: Real-world data suggests that NICT could be a favorable treatment option compared with PCT for patients with advanced NSCLC.

Comparison of long-term survival between nivolumab plus ...

Comparison of long-term survival between nivolumab plus ipilimumab with chemotherapy and pembrolizumab with chemotherapy in advanced non-small ...

Real-World Data of First-Line Cemiplimab Monotherapy for ...

Real-World Data of First-Line Cemiplimab Monotherapy for Metastatic Non-Small Cell Lung Cancer (NSCLC) with PD-L1 Expression ≥ 50%: A National ...

Nivolumab plus Ipilimumab in Advanced Non–Small-Cell ...

First-line treatment with nivolumab plus ipilimumab resulted in a longer duration of overall survival than did chemotherapy in patients with NSCLC.

Treatment Efficacy in Non–Small Cell Lung Cancer

What we saw were in line with those results, that PD-1 blockade with cemiplimab improves survival compared to chemotherapy. We saw an ...