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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median progression-free survival

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,821 Total Patients Enrolled

Paul Romesser, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Anti-PD-(L)1 based immunotherapy (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05657873 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Control Arm, L-SABR Arm

Non-Small Cell Lung Cancer Clinical Trial 2023: Anti-PD-(L)1 based immunotherapy Highlights & Side Effects. Trial Name: NCT05657873 — Phase 2

Anti-PD-(L)1 based immunotherapy (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05657873 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the U.S. Food and Drug Administration sanctioned L-SABR Arm?

"There is limited clinical evidence indicating L-SABR Arm's safety, thus it obtained a score of 2."

Answered by AI

Is this clinical trial presently open to new participants?

"As the information on clinicaltrials.gov shows, this experiment is currently trying to enlist participants. This trial was initially posted on December 9th 2022 and most recently updated on December 12th of the same year."

Answered by AI

How many research centers are overseeing this investigation?

"This investigation is being executed across 7 distinct clinical sites, which are located in Middletown, Montvale, Commack and 4 other nearby cities. To minimize the number of trips required to participate in this trial, it would be advantageous to select the closest site."

Answered by AI

What is the current participation rate of this medical experiment?

"Affirmative. Information posted on clinicaltrials.gov attests to the fact that this trial is presently recruiting participants; it was first made public on December 9th 2022 and has been recently updated on December 12th 2022. A total of 68 patients need to be enrolled across 7 medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

2022. "A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05657873.

All > Non Small Cell Lung Cancer > Nsclc