Photon vs Proton Radiation for Non-Small Cell Lung Cancer

Not currently recruiting at 30 trial locations

Overseen By Abraham J. Wu

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Radiation Therapy Oncology Group

Disqualifiers: Prior invasive malignancy, COPD, AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 39

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of radiation therapy—photon and proton radiation—to determine which works better with chemotherapy for treating non-small cell lung cancer that cannot be removed by surgery. The goal is to find out if proton radiation can target the tumor more effectively and safely than standard photon radiation. Individuals diagnosed with stage II-IIIB non-small cell lung cancer, which cannot be surgically removed, may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that proton beam therapy is generally safe for treating lung cancer. Studies indicate it causes fewer side effects than traditional radiation by targeting tumors more precisely and protecting nearby healthy tissue. Various studies report low rates of serious side effects with this treatment.

Photon beam therapy is also well-researched and widely used in cancer treatment. While generally safe, it can cause some side effects because it affects a larger area of tissue.

Both treatments are part of ongoing research aimed at improving their effectiveness and safety for lung cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about photon and proton beam radiation therapies for non-small cell lung cancer because they offer distinct advantages over traditional radiation treatments. Photon beam therapy is the current standard, but proton beam therapy is gaining attention due to its precision. Unlike photon therapy, which affects both cancerous and healthy tissues, proton therapy delivers radiation more precisely, potentially reducing damage to surrounding healthy tissues. This precision could lead to fewer side effects and improved outcomes for patients, making proton therapy a promising option in the fight against lung cancer.

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

Research has shown that proton beam therapy, one of the treatments studied in this trial, can target tumors more accurately than traditional methods, potentially causing less harm to healthy tissues. Studies have found that proton therapy is safe and effective for certain stages of non-small cell lung cancer. However, a review of multiple studies found that it does not significantly improve overall survival or the time patients live without cancer progression compared to other treatments. In contrast, photon beam therapy, the other treatment option in this trial, has a long history of use and is well-known. This trial will compare both treatments to determine if one provides better results for patients with non-small cell lung cancer that cannot be removed by surgery. ^{1 4 5 6 7}

Who Is on the Research Team?

Zhongxing Liao

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for adults with stage II-IIIB non-small cell lung cancer that can't be surgically removed. They should have acceptable organ function, no severe illnesses, and not have had certain previous cancer treatments. Women who can bear children must test negative for pregnancy and all participants must agree to use contraception.

Inclusion Criteria

My lung cancer diagnosis was confirmed through lab tests.

My nerve damage symptoms are mild or not present.

I am a woman who can have children and I have a negative pregnancy test from the last 14 days.

Exclusion Criteria

I am not pregnant and willing to use contraception if of childbearing potential.

I've had radiation in the same area as my current cancer.

I've had more than 4 cycles of chemo or over 6 months of targeted therapy for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo photon or proton beam radiation therapy 5 days per week for a total of 35 fractions, with concurrent chemotherapy

7 weeks

35 visits (in-person)

Consolidation Therapy

Beginning 3-6 weeks after chemoradiotherapy, patients receive additional chemotherapy or immunotherapy

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Long-term

Follow-up at 4-8 weeks, every 3 months for 1 year, every 6 months for 1 year, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Photon Beam Radiation Therapy
• Proton Beam Radiation Therapy

Trial Overview The study compares two types of radiation therapy (photon vs proton) combined with chemotherapy drugs like paclitaxel and carboplatin to see which is more effective in treating non-operable lung cancer without causing much damage to healthy tissue.

How Is the Trial Designed?

Group I: Arm II (proton beam radiation therapy and chemotherapy) Experimental Treatment 9 Interventions

Patients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* and carboplatin\*, etoposide and cisplatin, or pemetrexed and carboplatin (for non-squamous cell cancer patients only) as in Arm I. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy. CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.

Group II: Arm I (photon beam radiation therapy and chemotherapy) Active Control 9 Interventions

Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* IV over 1 hour and carboplatin\* IV weekly during radiation therapy or etoposide IV on days 1-5 and 29-33 and cisplatin IV on days 1, 8, 29, and 36. Patients with non-squamous cell cancer may receive pemetrexed IV and carboplatin IV on every 21 days. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy. CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.

Photon Beam Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Radiation Therapy for:

• Cancer treatment, including glioblastoma

Approved in European Union as Radiation Therapy for:

• Cancer treatment, including glioblastoma

Approved in Canada as Radiation Therapy for:

• Cancer treatment, including glioblastoma

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Published Research Related to This Trial

Proton beam therapy (PBT) can deliver lower radiation doses to surrounding healthy organs compared to traditional photon (X-ray) radiotherapy, potentially reducing side effects for lung cancer patients.

Early clinical results indicate that PBT, when combined with chemotherapy, shows lower toxicity rates and may improve survival outcomes, although further randomized studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy for locally advanced lung cancer: A review. Schild, SE., Rule, WG., Ashman, JB., et al.[2021]

Proton beam therapy for lung cancer significantly reduces the average dose of radiation to the lungs (Dmean) and the volume of lung receiving higher doses (V20, V10, V5) compared to both three-dimensional conformal photon radiotherapy (3D-CRT) and intensity-modulated photon radiotherapy (IMRT), based on an analysis of six clinical trials.

While proton therapy does not lower the average dose to the esophagus, it does reduce the dose to the heart, suggesting a safer profile for patients undergoing lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dosimetric comparing between protons beam and photons beam for lung cancer radiotherapy: a meta-analysis]. Tian, G., Li, N., Li, G.[2021]

Proton-beam therapy is an effective treatment option for non-small-cell lung cancer (NSCLC), especially for patients who cannot undergo surgery due to advanced disease or other medical conditions.

This type of radiotherapy allows for precise targeting of tumors, delivering high doses to the cancer while sparing surrounding healthy tissues, making it a promising alternative for lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of proton-beam therapy in the treatment of non-small-cell lung cancer. Oshiro, Y., Sakurai, H.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4586764/

Proton Beam Therapy for Non-Small Cell Lung Cancer Proton beam therapy, through its characteristic Bragg peak, has the potential to decrease the toxicity of radiotherapy, and, subsequently improve patient ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016781402500163X

Clinical outcomes of proton beam therapy for inoperable ... A meta-analysis revealed that PBT did not improve overall survival (OS) and progression-free survival (PFS) compared to SBRT, and the rate of serious adverse ...

3. advancesradonc.org advancesradonc.org/article/S2452-1094(21)00125-1/fulltext

Clinical Outcomes After Proton Beam Therapy for Locally ... Herein, we report clinical outcomes of patients treated with PBT for locally advanced non-small cell lung cancer (LA-NSCLC). Methods and ...

4. tlcr.amegroups.org tlcr.amegroups.org/article/view/30688/html

Proton therapy for non-small cell lung cancer: the road ahead High-dose hypofractionated proton beam radiation therapy is safe and effective for central and peripheral early-stage non-small cell lung cancer: results of ...

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(22)04550-9/fulltext

Cost-effectiveness of proton radiotherapy versus photon ... Proton radiotherapy (PT) is a promising but more expensive strategy than photon radiotherapy (XRT) for the treatment of non-small cell lung cancer (NSCLC).

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0169500225006816

Safety and outcomes of intensity modulated proton therapy ... Proton beam therapy (PBT) offers similar efficacy as photon beam radiotherapy, but with an improved safety profile. We retrospectively reviewed ...

7. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)00163-X/abstract

Clinical outcomes of proton beam therapy for inoperable ... This study provided real-world treatment outcomes of PBT for inoperable stage I-IIA NSCLC in Japan. Keywords. Proton beam therapy · Early stage · Non-small cell ...