Immunotherapy + Radiotherapy for Lung Cancer
(SCION Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byIslam Mohamed, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of British Columbia

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The SCION Trial is a clinical trial in patients with early stage non-small cell lung cancer. The purpose of the trial is to investigate whether it is safe and effective to combine standard radiation treatment with a drug called durvalumab, a type of immunotherapy. In addition, the study will use a blood test to look for cancer cell DNA to determine how long treatment with durvalumab should last. Both the use of durvalumab and the use of the blood test are new strategies for managing early stage non-small cell lung cancer.

Research Team

Islam Mohamed, MD

Principal Investigator

BC Cancer

Eligibility Criteria

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.

Inclusion Criteria

You are expected to live for at least 12 more weeks.

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

Your recent lab tests must show that your organs are working well before starting the treatment.

See 9 more

Exclusion Criteria

Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients

I haven't taken immunosuppressive drugs in the last 14 days.

I have had cancer before, but it fits the exceptions.

See 12 more

Treatment Details

Interventions

Circulating Tumor DNA assay (Diagnostic Test)
Durvalumab (PD-L1 Inhibitor)
Stereotactic Body Radiotherapy (Radiation)

Trial OverviewThis 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.

Participant Groups

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.

Durvalumab is already approved in Japan for the following indications: