Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UCSF
Dates
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 with SoC SBRT versus placebo with 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 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)

Details

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.

Keywords

Carcinoma, Non-Small-Cell Lung NSCLC Double- Blind PD-L1 MEDI4736 Durvalumab PFS OS Unresected lung cancer Inoperable SBRT SABR Lung Neoplasms

Eligibility

You can join if…

Open to people ages 18-130

  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. Planned SoC SBRT as definitive treatment
  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. Submission of available tumor tissue sample
  8. Adequate organ and marrow function required
  9. Patients with central or peripheral lesions are eligible
  10. . Staging studies must be done within 10 weeks before randomization
  11. . 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.

You CAN'T join if...

  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

Locations

  • Research Site not yet accepting patients
    San Francisco California 94143 United States
  • Research Site withdrawn
    San Francisco California 94115 United States
  • Research Site not yet accepting patients
    La Jolla California 92037 United States
  • Research Site accepting new patients
    San Diego California 92123 United States

Details

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