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

Status: closed to accrual

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.

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
Staging studies must be done during screening (PET-CT within 10 weeks)
Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions Main Cohort Key

Exclusion Criteria

Mixed small cell and non-small cell cancer
History of allogeneic organ transplantation
History of another primary malignancy with exceptions
History of active primary immunodeficiency
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 Osimertinib Cohort Key

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03833154.

State:

United States

Iowa

Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Status: Active

Name Not Available

Maryland

Baltimore

University of Maryland/Greenebaum Cancer Center

Status: Active

Contact: Rebecca Hudson

Phone: 410-328-4827

Email: rebecca.hudson@umm.edu

North Carolina

Chapel Hill

UNC Lineberger Comprehensive Cancer Center

Status: Active

Name Not Available

Patients with Stage I/II lymph node negative NSCLC and confirmed to meet all eligibility

criteria will be randomized 1:1 to receive either Durvalumab + SoC SBRT or placebo + SoC

SBRT.

The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC

SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the

efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of

Overall Survival (OS).

In addition, a study cohort with a sufficient number of patients harboring an EGFR-TKI

sensitizing mutation, will receive Osimertinib treatment after completion of SoC SBRT as

definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of

Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of

4-year PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb

treatment with SBRT.

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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

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

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