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PD-1 Inhibitor

Pembrolizumab + Radiation Therapy for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By James Welsh

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

At least one thoracic or liver lesion amenable to radiation, for group 5 we need one area that can safely receive SBRT or WFRT, not restricted to lung or liver sites

Pathologically confirmed non-small lung cancer; for patients in group 5, any solid tumor histology to be included

Must not have

Recent receipt of live vaccine

Diagnosis of immunodeficiency or receiving systemic steroid therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combo of immunotherapy and radiation therapy to treat non-small cell lung cancer and determine the best dose and side effects.

Who is the study for?

This trial is for adults with non-small cell lung cancer, including those with Stage IV metastatic disease. Participants must have at least one measurable tumor and be in good physical condition (ECOG 0 or 1). They should not be pregnant or breastfeeding, agree to use contraception, and meet specific blood criteria. Those with brain metastases can join under certain conditions but cannot have autoimmune diseases, recent monoclonal antibody treatments, or other disqualifying medical issues.

What is being tested?

The trial is testing the combination of Pembrolizumab (an immunotherapy drug) with different types of radiation therapy: Stereotactic Body Radiation Therapy which targets tumors precisely over fewer sessions, or conventional wide-field radiation therapy. The goal is to determine the best dose and effectiveness in shrinking tumors by enhancing the body's immune response against cancer cells.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs like lungs or intestines, skin reactions, hormonal gland problems leading to hormone imbalances, fatigue and infusion reactions. Radiation therapy might result in localized skin irritation, fatigue and damage to nearby tissues.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor in my chest or liver that can be treated with radiation.

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My cancer is confirmed to be non-small cell lung cancer or, for specific cases, any solid tumor type.

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I am not pregnant and will use birth control during the trial.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have more than one cancer lesion, and they can be seen on scans.

Exclusion Criteria

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

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I have recently received a live vaccine.

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I have an immune system disorder or I'm taking steroids.

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I have been diagnosed with an active autoimmune disease like scleroderma or lupus.

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I have had radiation therapy for all cancer spots in my chest and liver.

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I have a history of HIV or active hepatitis B or C.

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I've had severe side effects from previous cancer treatments.

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I have brain metastasis causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Disease response, according to immune related response criteria (Phase I/II)

Incidence of toxicity (Phase I/II)

Therapeutic radiology procedure

+2 more

Secondary study objectives

Overall survival

Progression-free survival (Phase II)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Group V, Phase II (low dose radiation therapy)Experimental Treatment7 Interventions

Patients with lesions amenable to SBRT or WFRT receive pembrolizumab IV as in Group I. Patients also receive either IMRT, PBRT, or 3D-CRT in 15 fractions to the primary lesions and low dose radiation therapy to other lesions on days 43-61 or SBRT in 4 fractions to primary lesions and low dose radiation therapy to other lesions on days 44-47.

Group II: Group IV, Phase II (pembrolizumab + XRT upon PD)Experimental Treatment5 Interventions

Patients who exhibit a lung lesion with size and location not amenable to SBRT, but amenable to WFRT receive pembrolizumab IV as in Group I without XRT. The decision on when to start XRT will be assessed first at week 5 (after the second dose of pembrolizumab). If a patient has PD based on irRC then XRT will be delivered after the third dose of pembrolizumab, while patients with SD or PR will not start XRT and will continue to be followed. These patients will then have follow up CT scans 5 weeks after course 3 and then approximately every 3 months for the remainder of the trial; any patient at this point with PD will then have XRT delivered with the sixth dose of pembrolizumab.

Group III: Group III, Phase II (pembrolizumab + IMRT, PBRT, or 3D-CRT)Experimental Treatment4 Interventions

Patients who exhibit a lung lesion with size and location not amenable to SBRT, but amenable to WFRT receive pembrolizumab IV as in Group I and IMRT, PBRT, or 3D-CRT on days 43-61.

Group IV: Group II, Phase II (pembrolizumab + XRT upon PD)Experimental Treatment6 Interventions

Patients who exhibit a lung lesion with size and location amenable to SBRT receive pembrolizumab IV as in Group I without XRT. At the first planned efficacy evaluation (5 weeks), patients exhibiting PD are treated with SBRT concurrent with the remaining cycles of pembrolizumab. In the event that lesion size has progressed to the point where the attending physician no longer considers SBRT safe, then the patient will be salvaged with IMRT, PBRT, or 3D-CRT and analyzed as part of the fourth treatment group.

Group V: Group II, Phase I (pembrolizumab + IMRT, PBRT or 3D-CRT)Experimental Treatment5 Interventions

Patients who exhibit a lung lesion of size or location not amenable to SBRT, but amenable to WFRT receive pembrolizumab as in Group I and either IMRT, PBRT, or 3D-CRT in 15 fractions total on days 1-19 concurrent with pembrolizumab administration.

Group VI: Group I, Phase II (pembrolizumab + SBRT)Experimental Treatment3 Interventions

Patients who exhibit a lung lesion with size and location amenable to SBRT receive pembrolizumab IV on day 1 and SBRT on days 44-47 or IMRT, PBT, or 3D-CRT on days 43-61. Treatment with pembrolizumab repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

Group VII: Group I, Phase I (pembrolizumab + SBRT)Experimental Treatment6 Interventions

Patients who exhibit a lung lesion of size and location amenable to SBRT receive pembrolizumab IV over 30 minutes on day 1. Patients also receive SBRT in 4 fractions daily on days 2-5 or either IMRT, PBRT, or 3D-CRT in 15 fractions total concurrent with pembrolizumab administration on days 1-19. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7230