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PD-L1 Inhibitor

Targeted Radiation + Drug Therapy for Lung Cancer

Phase 2

Recruiting

Led By Paul Romesser, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Be greater than 18 years of age on day of signing informed consent.

Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy.

Must not have

Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease.

Men or women not using effective contraception.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if adding radiation to drug therapy for NSCLC can improve treatment effectiveness.

Who is the study for?

This trial is for adults over 18 with stage IV NSCLC without certain genetic mutations, who have liver metastases and are starting standard immunotherapy +/- chemotherapy. They must have a decent performance status and normal liver function tests. People with active hepatitis, prior liver radiation, pregnancy/breastfeeding, ineffective contraception use or significant immunosuppression can't join.

What is being tested?

The study is testing if adding targeted radiation therapy (L-SABR) to the usual drug treatments (anti-PD-(L)1 based immunotherapy and platinum-based chemotherapy) provides better outcomes for patients with metastatic NSCLC that has spread to the liver.

What are the potential side effects?

Potential side effects include those from standard therapies like fatigue, nausea from chemo; skin reactions from radiotherapy; immune-related effects like inflammation from immunotherapy. Each treatment's side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old.

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I am starting standard immunotherapy with or without chemotherapy soon.

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I have newly diagnosed lung cancer that has spread to my liver.

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My stage IV lung cancer does not have specific genetic changes.

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I am a candidate for targeted radiation therapy on liver cancer spots.

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I can take care of myself and am up and about more than half of my waking hours.

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I am starting or planning to start standard care with anti-PD(L)-1 therapy alone or with chemotherapy.

Exclusion Criteria

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

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I am on long-term steroids or drugs for immune conditions.

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I am not using any form of birth control.

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I have active Hepatitis B or C.

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I have had radiation therapy targeted at my liver before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Median progression-free survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: L-SABR ArmExperimental Treatment3 Interventions

Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR/Liver Stereotactic Ablative Radiation Therapy.

Group II: Control ArmActive Control2 Interventions

Participants randomized to the control arm will be treated according to the standard of care.

0 / 11Eligibility criteria met