Phase III Study of Durvalumab With or Without Tremelimumab Compared to Standard Treatment in Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT02453282

Provider View

This study is testing the effectiveness and safety of the drug Durvalumab, alone or with Tremelimumab, compared to standard chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) without specific genetic mutations.

Patient Parameters

Program Overview

This clinical trial is exploring whether the drug Durvalumab, either by itself or combined with another drug called Tremelimumab, is more effective and safe compared to the usual platinum-based chemotherapy for treating patients with advanced non-small cell lung cancer (NSCLC) that does not have certain genetic mutations (EGFR or ALK).

Description

Participants in this study will be randomly assigned to one of three groups: one group will receive a combination of Durvalumab and Tremelimumab, another group will receive only Durvalumab, and the third group will receive the standard chemotherapy treatment. The goal is to see which treatment works best as a first-line therapy for patients with advanced NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have a confirmed diagnosis of Stage IV non-small cell lung cancer (NSCLC).
  • Cancer must not have specific genetic changes known as EGFR mutations or ALK rearrangements.
  • Must not have received any prior chemotherapy or systemic therapy for advanced NSCLC.
  • Must have a good overall health status, with a WHO performance status of 0 or 1.

Exclusion Criteria

  • Have a type of lung cancer that includes small-cell lung cancer or a sarcomatoid variant.
  • Have brain metastases or spinal cord compression unless they are symptom-free, treated, and stable without needing steroids.
  • Have previously received certain types of immune therapies, including drugs targeting CTLA-4, PD-1, PD-L1, or PD-L2, except for cancer vaccines.
  • Have active or previously diagnosed autoimmune or inflammatory disorders, such as inflammatory bowel disease (e.g., colitis or Crohn's disease).

Locations

FACILITYZIPCITYSTATE
Research Site85259ScottsdaleArizona
Research Site85715TucsonArizona
Research Site85364YumaArizona
Research Site93309BakersfieldCalifornia
Research Site92835FullertonCalifornia
Research Site92093La JollaCalifornia
Research Site90024Los AngelesCalifornia
Research Site90073Los AngelesCalifornia
Research Site90277Redondo BeachCalifornia
Research Site95817SacramentoCalifornia

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