Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
AstraZeneca
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief 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 unrese...
Detailed Description
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 obj...
Eligibility Criteria
Inclusion
- Main Cohort Key
- 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
- 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 Inclusion Criteria
- Age ≥18 years
- Planned SoC SBRT as definitive treatment
- WHO/ECOG PS of 0, 1, or 2
- Patients with central or peripheral lesions are eligible
- Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
- Staging studies must be done during screening (PET-CT within 10 weeks)
- Submission of tumor tissue sample if available
- Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
- Adequate bone marrow reserve or organ function required
- Female patients should be using highly effective contraceptive measures
- Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation
- Osimertinib Cohort Key Exclusion Criteria
- Mixed small cell and non-small cell cancer
- Patients with known or increased risk factor for QTc prolongation
- Treatment with any of the following:
- Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
- Prior treatment with neoadjuvant or adjuvant EGFR TKI
- Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
- Any of the following cardiac criteria
- Mean resting corrected QT interval \>470 msec, obtained from 3 ECGs
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2028
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT03833154
Start Date
March 6 2019
End Date
April 4 2028
Last Update
November 10 2025
Active Locations (209)
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1
Research Site
Tuscaloosa, Alabama, United States, 35401
2
Research Site
Chandler, Arizona, United States, 85224
3
Research Site
Phoenix, Arizona, United States, 85004
4
Research Site
Tucson, Arizona, United States, 85719