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PD-L1 Inhibitor

Immunotherapy + Radiotherapy for Lung Cancer (SCION Trial)

Phase 2

Recruiting

Led By Islam Mohamed, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

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

Must have

Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients

ECOG Performance status (PS) 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (ct) and 12 months (pet/ct)

Awards & highlights

SCION Trial Summary

This trial is testing a new immunotherapy drug to see if it's effective and safe to use with standard radiation treatment for early stage non-small cell lung cancer. If successful, this could become a new standard of care.

Who is the study for?

The SCION trial is for adults over 18 with early stage non-small cell lung cancer who haven't had chemotherapy and can't or won't have surgery. Participants must be able to consent, weigh over 30kg, have an ECOG status of 0-2, and a life expectancy of at least 12 weeks. They should not have other cancers, active infections like TB or hepatitis, or be on immunosuppressants.Check my eligibility

What is being tested?

This study tests combining Stereotactic Body Radiotherapy (a precise radiation therapy) with Durvalumab (an immunotherapy drug), alongside monitoring treatment response through a blood test that detects cancer DNA. The goal is to determine the safety and effectiveness of this combination in managing early-stage lung cancer.See study design

What are the potential side effects?

Durvalumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid issues), fatigue, nausea, and potential infusion-related reactions during administration.

SCION Trial Eligibility Criteria

Inclusion Criteria

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

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I am post-menopausal or have a negative pregnancy test if pre-menopausal.

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I can take care of myself and perform daily activities.

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My body weight is over 30kg.

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I have not had, nor am I planning to have, chemotherapy.

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I cannot undergo surgery for my condition, or I chose not to have surgery after a surgical evaluation.

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I am over 18, can make my own decisions, and agree to follow study rules.

SCION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months (ct) and 12 months (pet/ct)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months (ct) and 12 months (pet/ct)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (ct) and 12 months (pet/ct) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Risk of Relapse

Secondary outcome measures

Adverse Events

Cause-Sepcific Survival

Distant Metastatic Relapse

+10 more

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00350142

15%

ulcer

10%

vomiting

Perforation

pain

100%

80%

60%

40%

20%

Study treatment Arm

SBRT With Gem

SCION Trial Design

3Treatment groups

Experimental Treatment

Group I: MRD Positive, no further therapyExperimental Treatment3 Interventions

All subjects will receive four cycles of durvalumab with SABR concurrent at cycle 2, then will be evaluated for MRD. Subjects in this arm have detectable ctDNA at MRD landmark and are randomized to no further therapy.

Group II: MRD Positive, consolidation durvalumabExperimental Treatment3 Interventions

Group III: MRD NegativeExperimental Treatment3 Interventions

All subjects will receive four cycles of durvalumab with SABR concurrent at cycle 2, then will be evaluated for MRD. Subjects in this arm have no detectable ctDNA at MRD landmark and will receive no further therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

FDA approved

Stereotactic Body Radiotherapy

2017

Completed Phase 2

~220

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ozmosis Research Inc.Industry Sponsor

20 Previous Clinical Trials

4,921 Total Patients Enrolled

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,467,024 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,271 Previous Clinical Trials

288,613,266 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04944173 — Phase 2

Lung Cancer Research Study Groups: MRD Negative, MRD Positive, no further therapy, MRD Positive, consolidation durvalumab

Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04944173 — Phase 2

Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04944173 — Phase 2

Frequently Asked Questions

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

Has enrollment in this experiment commenced yet?

"The data available on clinicaltrials.gov indicates that this research initiative is not currently searching for participants, despite having been posted in June 2021 and updated with recent information the month after. Nevertheless, there are numerous other studies recruiting patients as of now."

Answered by AI

Has Stereotactic Body Radiotherapy been authorized by the FDA?

"The safety of Stereotactic Body Radiotherapy was estimated by our team to be a 2, as there are some data in support of its security but no evidence demonstrating efficacy."

Answered by AI

How many participants are being administered the treatment within this research study?

"This trial is not presently accepting participants, with the first post date being June 1st 2021 and last update occurring on the 24th of the same month. Should you be searching for other options, there are 4,424 studies currently recruiting patients diagnosed with carcinoma non-small cell lung cancer as well 333 trials actively enlisting subjects for stereotactic body radiotherapy."

Answered by AI

What is the geographic dispersion of this clinical trial?

"Currently, this research project is accepting participants from 5 distinct sites. The cities of Victoria, Hamilton and Kelowna are all hosting these trials, along with an additional five locations. It would be prudent to choose the facility closest to you in order to minimize the need for travel when participating."

Answered by AI

Can you elaborate on the existing research into Stereotactic Body Radiotherapy?

"Stereotactic Body Radiotherapy first emerged in 2010 at City of Hope, a renowned medical centre located in California. Subsequently, there have been 112 successful investigations and 333 ongoing trials mostly being conducted out of Victoria, Canada."

Answered by AI

What pathologies does Stereotactic Body Radiotherapy typically target?

"Stereotactic Body Radiotherapy is commonly used to address the spread of incurable stage iii non-small cell lung cancer. It's also a viable option for those with untreated metastatic ureter urothelial carcinoma or advance directives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SCION: SABR and Checkpoint Inhibition Of NSCLC

Islam Mohamed 2023. "SCION: SABR and Checkpoint Inhibition Of NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04944173.

All > Non Small Cell Lung Cancer