Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Un… (NCT03833154) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation
United States724 participantsStarted 2019-03-06
Plain-language summary
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.
An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.
Who can participate
Age range18 Years – 130 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years
✓. Planned SoC SBRT as definitive treatment
✓. World Health Organization (WHO)/ECOG PS of 0, 1 or 2
✓. Life expectancy of at least 12 weeks
✓. Body weight \>30 kg
✓. Submission of tumor tissue sample if available
✓. Adequate organ and marrow function required
✓. Patients with central or peripheral lesions are eligible
Exclusion criteria
✕. Mixed small cell and non-small cell cancer
✕. History of allogeneic organ transplantation
✕. History of another primary malignancy with exceptions
✕
What they're measuring
1
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
Timeframe: from randomization up to 6 years
2
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
✕. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
✕. Prior exposure to immune-mediated therapy with exceptions