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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
Allowance for XRT prior to study entry to other sites
Stage IV metastatic disease (only during the phase II)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had radiation therapy to areas other than the cancer site before joining this study.
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My cancer is in stage IV and has spread to other parts of my body.
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I have a tumor in my chest or liver that can be treated with radiation.
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I agree to use birth control.
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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 have brain metastasis but meet specific conditions for treatment.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease response, according to immune related response criteria (Phase I/II)
Incidence of toxicity (Phase I/II)
Therapeutic radiology procedure
+2 moreSecondary outcome measures
Overall survival
Progression-free survival (Phase II)
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 2
~1950
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Radiation Therapy
2017
Completed Phase 3
~7250
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,213 Total Patients Enrolled
James WelshPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
314 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently received a live vaccine.I have had radiation therapy to areas other than the cancer site before joining this study.I have an immune system disorder or I'm taking steroids.I have been diagnosed with an active autoimmune disease like scleroderma or lupus.I have had radiation therapy for all cancer spots in my chest and liver.You have a history of mental health or drug problems.I have a history of HIV or active hepatitis B or C.Your blood and body chemistry need to meet certain standards.My cancer is in stage IV and has spread to other parts of my body.I have a tumor in my chest or liver that can be treated with radiation.I agree to use birth control.I've had severe side effects from previous cancer treatments.You have a disease that can be measured using specific criteria for immune system response.My cancer is confirmed to be non-small cell lung cancer or, for specific cases, any solid tumor type.I have brain metastasis but meet specific conditions for treatment.I am not pregnant and will use birth control during the trial.I have recently used specific cancer treatments like monoclonal antibodies or chemotherapy.You have certain medical conditions or abnormal test results.I am fully active or restricted in physically strenuous activity but can do light work.I have more than one cancer lesion, and they can be seen on scans.I have brain metastasis causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Group III, Phase II (pembrolizumab + IMRT, PBRT, or 3D-CRT)
- Group 2: Group I, Phase I (pembrolizumab + SBRT)
- Group 3: Group II, Phase II (pembrolizumab + XRT upon PD)
- Group 4: Group V, Phase II (low dose radiation therapy)
- Group 5: Group II, Phase I (pembrolizumab + IMRT, PBRT or 3D-CRT)
- Group 6: Group I, Phase II (pembrolizumab + SBRT)
- Group 7: Group IV, Phase II (pembrolizumab + XRT upon PD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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