Lung Cancer Trials Ask AI to find trials
CompletedPhase 2NCT03825510
Official study title

Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect

Study summary

The purpose of this study is to determine efficacy, safety of Stereotactic Body Radiotherapy (SBRT) in combination with immunotherapy in participants with metastatic non-small cell lung cancer (NSCLC) who are eligible for an immunotherapy agent.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Body Radiotherapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 6, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Crozer-Keystone Health System

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Crozer-Keystone Health System
Interventions being studied
Radiation: Stereotactic Body Radiotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Histologically or cytologically confirmed Stage IV NSCLC according to the 7th AJCC staging manual.
  • Eligible for an immunotherapy agent. Patients who progress after drug therapy (3 months) for ALK, EGFR or ROS mutation positive lung cancer are eligible.
  • At least 2 lesions that are safely amenable to SBRT. ECOG \<=2.
  • At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment or at least 1 lesion with FDG avidity and CT correlate that can be monitored for PET-CT response by SUV Max increase or decrease.
  • Normal Hepatic and renal function.
  • Bone marrow reserve: 1. ANC ≥ 1.5 x 109/L 2. Hemoglobin ≥9.0 g/dL 3. Platelet count ≥75 x 109/L
  • Ability to comply with follow-up visits and evaluations, treatment planning and studies and other study related procedures and visits.
  • Ability to sign informed consent.
Reasons someone may not be able to joinExclusion criteria
  • Patients with active CNS metastases
  • Active, known or suspected auto-immune disease.
  • Patients with medical conditions that require systemic immunosuppression.
  • Patients with a history of interstitial lung disease.
  • Prior treatment with immune checkpoint inhibitors/immonotherapy.
  • Other active malignancy requiring intervention.
  • Prior lung radiation, with the only metastatic targets in the lungs.
  • Unresolved toxicity from prior chemotherapy or anti-cancer treatment.
  • Current or prior enrollment in clinical trial with an investigational drug within 4 weeks.
  • Pregnancy or positive pregnancy test.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Philadelphia CyberKnifePhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 6, 2023. Always confirm current availability with the study team.

View original record ↗