Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer Patients

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    706
  • sponsor
    AstraZeneca
Updated on 28 April 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (5.5 mi away) Contact
+226 other location
stereotactic body radiation therapy
durvalumab
lung carcinoma

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.

Description

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 this study 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 OS.

Details
Condition Non-Small Cell Lung Cancer
Treatment Placebo, SBRT, durvalumab
Clinical Study IdentifierNCT03833154
SponsorAstraZeneca
Last Modified on28 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
Planned SoC SBRT as definitive treatment
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
Life expectancy of at least 12 weeks
Body weight >30 kg
Submission of available tumor tissue sample
Adequate organ and marrow function required
Patients with central or peripheral lesions are eligible
Staging studies must be done within 10 weeks before randomization
Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated definitively surgery only or SBRT only >1 year prior to enrollment are eligible

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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