Details

IRB Study Number SSU00233596

Status Recruiting

Phase Phase 2

Locations Robert and Carol Weissman Cancer Center, Martin North Hospital

Institute Taussig Cancer Institute

Description

Description

The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based CT given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or CRT and consolidation durvalumab given alone as further therapy in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.

The target population of interest in this study is participants with resectable and borderline resectable stage IIB-IIIB NSCLC.

Inclusion Criteria

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Participant must be ≥ 18 years, at the time of screening
  2. Histologically or cytologically documented NSCLC.
  3. Deemed resectable or borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.
  4. Previously untreated and pathologically confirmed stage IIB to select (ie, N2) stage IIIB disease
  5. Participants must have been confirmed as EGFR/ALK wild type via an appropriately validated local test
  6. At least one lesion not previously irradiated.
  7. Adequate organ and bone marrow function
  8. The participant should be deemed to have adequate cardiac and lung function, according to a multidisciplinary assessment.
  9. Minimum body weight of 30 kg.
  10. Negative pregnancy test (serum) for FOCBP.
  11. Female participants must be for 1 year or more post-menopausal, surgically sterile, or using at least one highly effective method of contraception.
  12. Male participants who intend to be sexually active with a female partner of child-bearing potential must be surgically sterile or using an acceptable method of contraception.
  13. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent form.

Exclusion Criteria

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

  1. Deemed unresectable NSCLC by multidisciplinary evaluation
  2. Participants whose planned surgery at enrolment includes wedge resections.
  3. Participants contraindicated for surgical intervention due to comorbid conditions.
  4. Existence of more than one primary tumour, such as: mixed small cell and NSCLC histology
  5. History of another primary malignancy except for malignancy treated with curative-intent with no known active disease ≥ 5 years before the first dose of study intervention.
  6. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease.
  7. Known active hepatitis infection, positive HCV antibody, HBsAg or HBV core antibody (anti-HBc), at screening.
  8. History of active primary immunodeficiency
  9. Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines