Immunotherapy + Radiation for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for stage II-III non-small cell lung cancer using a combination of immunotherapy drugs, ipilimumab (Yervoy) and nivolumab (Opdivo), along with radiation. Researchers aim to evaluate the effectiveness of this combination and identify potential side effects. This approach seeks to enhance the immune system's ability to attack cancer more effectively than standard chemotherapy and radiation. The trial is best suited for individuals diagnosed with stage II-III non-small cell lung cancer who have not yet received therapy for this stage. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on active chronic treatment with systemic immunosuppressive medications. If you are on such medications, you may need to stop them before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining nivolumab and ipilimumab with radiation therapy is generally safe for individuals with non-small cell lung cancer. In past studies, patients received these treatments together and tolerated them well. For instance, this combination proved safe for patients whose lung cancer had spread to the brain when used with radiation.
Another study found that low-dose radiation with these drugs was also well-tolerated, although it didn't always result in significant improvements. Additionally, when radiation was carefully targeted to avoid damaging healthy tissues, the combination with these drugs remained safe.
Overall, these studies suggest that combining nivolumab and ipilimumab with radiation is generally well-tolerated, though individual experiences may vary.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining immunotherapy with radiation for lung cancer because it targets the disease in a novel way. Unlike traditional treatments that often focus solely on chemotherapy or radiation, this approach uses two immunotherapy drugs, ipilimumab and nivolumab, to supercharge the body's immune system, helping it recognize and attack cancer cells more effectively. The combination of these drugs with radiation therapy is believed to enhance the overall treatment efficacy, potentially leading to better outcomes by attacking the cancer on multiple fronts. This multifaceted strategy could offer new hope for patients who have limited options with existing therapies.
What evidence suggests that this combination of immunotherapy and radiation therapy might be an effective treatment for non-small cell lung cancer?
Research has shown that using the drugs nivolumab and ipilimumab with radiation therapy might help treat lung cancer. In this trial, participants will receive this combination treatment. Studies on patients with advanced non-small cell lung cancer (NSCLC) have found that this combination can help the immune system fight cancer cells more effectively. These drugs may make cancer cells more responsive to radiation, enhancing the treatment's effectiveness. Although this combination has been used in other stages of cancer, it has shown promise in shrinking tumors and controlling the spread of cancer. Early results suggest this approach could be a strong option for treating stage II-III NSCLC.36789
Who Is on the Research Team?
Anne S Tsao
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with stage II-III non-small cell lung cancer that can't be removed by surgery or patients who refuse surgery. They must have a good performance status, meaning they're fairly active and able to care for themselves. People with certain stable autoimmune conditions or controlled diabetes may join. However, those with recent other cancers, severe allergies to similar drugs, untreated infections like TB or hepatitis, HIV, or on immunosuppressive therapy cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Concurrent Therapy
Patients receive nivolumab and ipilimumab intravenously, and undergo radiation therapy 5 days a week for 6-7 weeks
Maintenance Therapy
Patients receive nivolumab intravenously every 28 days for up to 8 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Radiation Therapy
Trial Overview
The trial tests the combination of two immune system-boosting drugs (Ipilimumab and Nivolumab) with radiation therapy against lung cancer. The goal is to see if this combo helps the body's own defense system fight cancer better and makes tumor cells more sensitive to radiation compared to standard chemotherapy plus radiation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
CONCURRENT THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 30 minutes on day 1. Treatment with nivolumab repeats every 21 days for up to 8 cycles, and treatment with ipilimumab repeats every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 1 day of starting nivolumab and ipilimumab, patients also undergo radiation therapy 5 days a week (Monday-Friday) over 6-7 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Study Details | NCT03223155 | Concurrent or Sequential ...
Patients with stage IV non-small cell lung cancer are randomized to nivolumab/ipilimumab plus either sequential or concurrent stereotactic body radiotherapy ( ...
676P NEJ053C: A phase II study of nivolumab and ...
Nivolumab + ipilimumab + chemotherapy after lung stereotactic body radiotherapy may be effective as first-line therapy for stage IV NSCLC, but its safety ...
Nivolumab and ipilimumab with concurrent stereotactic ...
Concurrent brain SRS with nivolumab/ipilimumab was safe for patients with active NSCLC BM. Preliminary analyses of treatment efficacy were ...
A Phase 1 Trial of Concurrent or Sequential Ipilimumab ...
This randomized phase 1 trial combined nivolumab and ipilimumab with sequential or concurrent multisite SBRT in patients with stage IV NSCLC to ...
Combining stereotactic body radiotherapy with ...
Here, we review the current clinical evidence supporting the combination of SBRT with immunotherapy in the treatment of metastatic NSCLC.
analysis of the safety cohort for non-randomized, open-label ...
Conclusion: Concurrent brain SRS with nivolumab/ipilimumab was safe for patients with active NSCLC BM. Preliminary analyses of treatment efficacy were ...
Nivolumab and ipilimumab with concurrent stereotactic ...
Concurrent brain SRS with nivolumab/ipilimumab was safe for patients with active NSCLC BM. Preliminary analyses of treatment efficacy were encouraging for ...
NeoRad(Low): A phase 2 trial of neoadjuvant (NA) ...
Conclusions: Low-dose radiation with concurrent NA ipi + nivo was safe and well tolerated in this small cohort but did not improve MPR compared ...
Safety of combined ablative radiotherapy and immune ...
We conclude that multi-site SBRT and ICI can be safely co-administered when SBRT is delivered with prioritization of normal tissue constraints.
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