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 Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)
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.
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
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).
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.
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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