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Radiation + Immunotherapy for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Raid Aljumaily

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants must have measurable or non-measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to Registration Step 1. Non-measurable disease must be assessed within 42 days prior to Step 1 registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)

Patient must not have had a prior history of interstitial lung disease or > grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 5) pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of step 2 registration to date of death due to any cause, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a new cancer treatment that involves radiation therapy followed by immunotherapy with atezolizumab.

Who is the study for?

This trial is for adults with stage II or III non-small cell lung cancer who've had prior treatments like surgery, chemo, or radiation but not within the last year. They must have proper liver and kidney function, no severe active infections, HIV under control, and can't be pregnant. People with certain blood counts and those who haven't used high-dose steroids recently can join. It's not for those with autoimmune diseases needing treatment in the past 6 months or a history of significant lung disease.

What is being tested?

The study tests if giving smaller doses of radiation over time (hypofractionated radiation therapy) before atezolizumab—an immune system-boosting drug—can effectively treat non-small cell lung cancer with fewer side effects than standard treatments.

What are the potential side effects?

Possible side effects include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation in organs like lungs or intestines (which could cause coughing or diarrhea), potential liver issues indicated by blood test changes, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be seen on scans taken within the last 28 to 42 days.

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I have never had interstitial lung disease or severe lung inflammation.

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I completed my radiation treatment and received at least 44 Gy within the last 42 days.

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I haven't needed treatment for an autoimmune disease in the last 6 months.

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I haven't taken high doses of steroids in the last 2 weeks.

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I do not have any infections that need treatment.

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My lung cancer has been confirmed by lab tests.

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My lung cancer is stage II or III, and I can care for myself but might not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of step 2 registration to date of death due to any cause, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of step 2 registration to date of death due to any cause, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of step 2 registration to date of death due to any cause, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of grade 3-5 adverse events

Secondary study objectives

Incidence of adverse events

Overall survival

Progression-free survival

+2 more

Side effects data

From 2023 Phase 3 trial • 107 Patients • NCT03324802

80%

Dermatitis radiation

54%

Skin hyperpigmentation

48%

Pain

35%

Lymphedema

22%

Superficial soft tissue fibrosis

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1 (Radiation Therapy, 15 Fractions)

Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (hypofractionated radiation therapy, atezolizumab)Experimental Treatment5 Interventions

RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Biospecimen Collection

2004

Completed Phase 3

~2030