Photon vs Proton Radiation for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+29 other locations

Overseen ByZhongxing Liao

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

Eligibility Criteria

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.

My kidney function is normal, based on recent tests.

My cancer is at stage II, IIIA, or IIIB and cannot be removed by surgery.

My lung cancer has spread to nearby lymph nodes but the primary tumor can't be found.

I have chosen not to undergo surgery for my condition.

My white blood cell count is healthy.

I have fluid in my chest that is not caused by cancer.

My cancer returned after surgery and I am eligible for combined chemotherapy and radiation.

My cancer has not spread to distant parts of my body.

Exclusion Criteria

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

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

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

I have had lung cancer before, regardless of the type or treatment.

I have lost more than 10% of my weight without trying in the last month.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (proton beam radiation therapy and chemotherapy)Experimental Treatment9 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 Control9 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: