164 Participants NeededMy employer runs this trial

Radiation Therapy for Non-Small Cell Lung Cancer

Recruiting at 96 trial locations
AC
Overseen ByAmanda Clark
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alliance for Clinical Trials in Oncology
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 tests whether intensity-modulated radiation therapy (IMRT) can enhance the treatment of non-small cell lung cancer when combined with standard treatments like chemotherapy or immunotherapy. IMRT uses computer-guided radiation beams to target tumors while sparing healthy tissue, potentially reducing side effects. The study aims to determine if adding IMRT after surgery can lower the risk of cancer recurrence. Individuals with non-small cell lung cancer who have undergone surgery and still have cancer in their lymph nodes might be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking a VEGF inhibitor, you must not have used it within 90 days before joining the trial.

Is there any evidence suggesting that intensity-modulated radiation therapy is likely to be safe for humans?

In a previous study, patients who received Intensity-Modulated Radiation Therapy (IMRT) experienced fewer lung problems. Specifically, serious lung issues like pneumonitis, or lung inflammation, occurred in only 3.5% of patients using IMRT, compared to 8.2% with older radiation methods. Another study demonstrated that IMRT reduced exposure to critical areas like the heart and lungs, lessening unwanted side effects. Overall, research has shown that IMRT is generally well-tolerated and has fewer complications, making it a promising option for those considering clinical trials for non-small cell lung cancer.12345

Why are researchers excited about this trial's treatment for non-small cell lung cancer?

Unlike the standard treatments for non-small cell lung cancer, which typically involve chemotherapy or immunotherapy alone, Intensity-Modulated Radiation Therapy (IMRT) offers a more targeted approach. This technique allows for precise delivery of radiation, minimizing damage to surrounding healthy tissues and potentially reducing side effects. Researchers are particularly excited about the integration of IMRT with standard chemotherapy or immunotherapy because it could enhance the effectiveness of the overall treatment regimen. By combining these strategies, there is hope for improved outcomes and better quality of life for patients.

What evidence suggests that intensity-modulated radiation therapy is effective for non-small cell lung cancer?

Research has shown that intensity-modulated radiation therapy (IMRT) can benefit patients with non-small cell lung cancer (NSCLC). Studies have found that IMRT limits radiation exposure to healthy tissues, potentially reducing side effects such as serious lung inflammation and heart problems. For instance, one study discovered that IMRT more than halved the likelihood of severe lung issues compared to older methods. Additionally, patients who received IMRT demonstrated better survival rates at various stages of NSCLC. In this trial, participants in Arm II will undergo I²-PORT, a form of IMRT, alongside standard treatments like chemotherapy or immunotherapy, which might improve the chances of controlling cancer after surgery.25678

Who Is on the Research Team?

DK

David Kozono, MD

Principal Investigator

Alliance for Clinical Trials in Oncology

JB

Jeremy Brownstein, MD

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

This trial is for adults (18+) with non-small cell lung cancer who still have cancer in their lymph nodes after surgery and prior chemotherapy. Participants must not have certain genetic mutations, no signs of cancer spread, and must not have had previous radiation to the chest.

Inclusion Criteria

I had surgery that fully removed my tumor, but cancer was found in my lymph nodes.
I am 18 or older and have not used VEGF inhibitors in the past 90 days.
I have non-small cell lung cancer without any small cell features.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo intensity-modulated post-operative radiation therapy (I²-PORT) once daily Monday through Friday over 15-25 fractions

5-6 weeks
Daily visits (Monday through Friday)

Chemotherapy/Immunotherapy

Patients receive standard of care chemotherapy or immunotherapy starting 1-42 days after completion of I²-PORT

Variable, based on treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 3 months for 2 years, then every 6 months for 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Intensity-Modulated Radiation Therapy

Trial Overview

The study compares adding targeted post-surgery radiation therapy (intensity-modulated radiation) to standard treatment (chemotherapy or immunotherapy) versus standard treatment alone in people with remaining lymph node cancer after NSCLC surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (I²-PORT, SOC chemotherapy/immunotherapy)Experimental Treatment7 Interventions
Group II: Arm I (SOC chemotherapy/immunotherapy)Active Control6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Modern Radiation Further Improves Survival in Non-Small ...

Conclusion: Radiation therapy was correlated with increased overall survival for all patients with primary NSCLC across stages. Combined surgery and ...

Data Support IMRT as Standard of Care for Locally Advanced ...

A lower radiation dose of 60Gy was associated with improved survival compared to 74Gy, HR=1.28 (p=0.03). There was no survival difference based ...

Intensity-Modulated Radiotherapy of the Lung

Dosimetry studies have shown that IMRT can reduce radiation exposure to critical surrounding structures, especially in large lung tumors. Based on nonrandomized ...

Impact of Intensity-Modulated Radiation Therapy ...

IMRT was associated with lower rates of severe pneumonitis and cardiac doses in NRG Oncology clinical trial RTOG 0617, which supports routine use of IMRT for ...

Intensity-modulated radiation therapy provides long-term ...

Patients treated with IMRT had lower rates of toxicity to lungs and less radiation to the heart compared to conventional chemoradiation.

IMRT in the treatment of locally advanced or inoperable ... - PMC

The objective of this study was to evaluate the efficacy and safety of IMRT in patients with inoperable NSCLC and to describe the pattern of relapses.

Intensity-Modulated Radiotherapy for Lung Cancer

With a median 16.5 months follow-up, 2-year disease free and OS were 38% and 46%, respectively. Other centers have also published encouraging retrospective ...

Intensity-Modulated Radiotherapy of the Lung

Dosimetry studies have shown that IMRT can reduce radiation exposure to critical surrounding structures, especially in large lung tumors. Based on nonrandomized ...