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

  • Interventional
  • Recruiting
  • NCT03833154
Eligibility Details Visit Clinicaltrials.gov

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 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.

Gender
All

Age Group
18 Years to 130 Years

Accepting Healthy Volunteers?
No

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. 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.

        Key Exclusion Criteria:

         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

At a Glance

National Government IDNCT03833154

IRB#IRB21-0056

Lead SponsorAstraZeneca

Lead PhysicianSteven Chmura

Collaborator(s)N/A

EligibilityAll
18 Years to 130 Years
Recruiting