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Photon Beam Therapy

Photon vs Proton Radiation for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Led By Zhongxing Liao

Research Sponsored by Radiation Therapy Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically proven diagnosis of non-small cell lung cancer

Peripheral neuropathy =< grade 1 at the time of registration

Must not have

Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Prior systemic chemotherapy for the study cancer, if more than 4 cycles of induction chemotherapy or more than 6 months of targeted therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to end of follow-up

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two types of radiation therapy to see which is more effective in treating patients with stage II-IIIB non-small cell lung cancer- proton chemoradiotherapy versus photon chemoradiotherapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include fatigue, skin reactions at the treatment site, nausea, hair loss from chemotherapy drugs, as well as potential risks associated with radiation such as inflammation of surrounding organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer diagnosis was confirmed through lab tests.

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My nerve damage symptoms are mild or not present.

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My kidney function is normal, based on recent tests.

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

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

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I have chosen not to undergo surgery for my condition.

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My white blood cell count is healthy.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration until death or last follow-up; analysis occurs after 390 deaths have been reported

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration until death or last follow-up; analysis occurs after 390 deaths have been reported

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration until death or last follow-up; analysis occurs after 390 deaths have been reported for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Adverse events

Progression-free survival

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

Etoposide

FDA approved