Summary

for people ages 18-130 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab versus placebo following SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

Official Title

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following 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)

Details

Patients who complete definitive treatment with SoC SBRT and are 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 monotherapy compared to placebo in terms of PFS. Key secondary is to assess the efficacy of Durvalumab monotherapy compared to placebo in terms of OS.

Keywords

Carcinoma, Non-Small-Cell Lung NSCLC Double- Blind PD-L1 MEDI4736 Durvalumab PFS OS Antibodies, Monoclonal Durvalumab Therapy

Eligibility

For people ages 18-130

Key Inclusion Criteria:

  1. Age ≥18 years
  2. 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
  3. Completion of SoC SBRT as definitive treatment prior to randomization
  4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
  5. Life expectancy of at least 12 weeks
  6. Body weight >30 kg
  7. Tumor sample required
  8. Adequate organ and marrow function required
  9. Patients with central or peripheral lesions are eligible
  10. . Staging studies must be done within 8 weeks before randomization

Key Exclusion Criteria:

  1. Mixed small cell and non-small cell cancer histology
  2. History of allogeneic organ transplantation
  3. History of another primary malignancy with exceptions
  4. History of active primary immunodeficiency
  5. Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade ≥2 from SBRT (Stereotactic Body Radiation Therapy)

Locations

  • Research Site not yet accepting patients
    San Francisco California 94143 United States
  • Research Site withdrawn
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT03833154
Phase
Phase 3
Study Type
Interventional
Last Updated