Durvalumab vs Placebo With Stereotactic Body Radiation Therapy 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
18 - 130 Years, Male and Female
D9103C00001 (primary)
NCI-2019-02609
2018-002572-41
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.
Objectives
Patients who are to receive SoC SBRT as definitive treatment of Stage I/II lymph
node-negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1
to Durvalumab or placebo.
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
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 4years-PFS.
Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with
SBRT.
Eligibility
- Age =18 years
- Planned SoC SBRT as definitive treatment
- 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
Treatment Sites in Georgia
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com
960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342
404-303-3355
www.ugynonc.com
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