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Pacific 4: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative NSCLC
Description
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.
Learn more at clinicaltrials.gov
Eligibility Criteria
Inclusion
- 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
- 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