A Study to Compare Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy  (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Main Cohort Key Inclusion Criteria:

1. Age ≥18 years

2. Planned SoC SBRT as definitive treatment

3. WHO/ECOG PS of 0, 1 or 2

4. Life expectancy of at least 12 weeks

5. Body weight >30 kg

6. Submission of tumor tissue sample if available

7. Adequate organ and marrow function required

8. Patients with central or peripheral lesions are eligible

9. Staging studies must be done during screening (PET-CT within 10 weeks)

10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible
with some exceptions

Main Cohort Key Exclusion Criteria:

1. Mixed small cell and non-small cell cancer

2. History of allogeneic organ transplantation

3. History of another primary malignancy with exceptions

4. History of active primary immunodeficiency

5. 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

6. Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Inclusion Criteria

1. Age ≥18 years

2. Planned SoC SBRT as definitive treatment

3. World Health Organization (WHO)/ECOG PS of 0, 1, or 2

4. Patients with central or peripheral lesions are eligible

5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible
with some exceptions

6. Staging studies must be done during screening (PET-CT within 10 weeks)

7. Submission of available tumor tissue sample

8. 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)

9. Adequate bone marrow reserve or organ function required

10. Female patients should be using highly effective contraceptive measures

11. 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

1. Mixed small cell and non-small cell cancer

2. Patients currently receiving potent inducers of CYP3A4

3. Patients with known or increased risk factor for QTc prolongation

4. 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

5. 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

Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Merrell, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

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