Study on Durvalumab and Tremelimumab for Limited Stage Small-Cell Lung Cancer After Chemoradiation

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03703297

This clinical trial is testing the effectiveness of the drugs Durvalumab and Tremelimumab, compared to a placebo, in patients with limited stage small-cell lung cancer who have not shown disease progression after receiving chemoradiation therapy.

Patient Parameters

Program Overview

The purpose of this study is to evaluate whether the drugs Durvalumab and Tremelimumab can help control limited stage small-cell lung cancer (LS-SCLC) in patients who have completed chemoradiation therapy and have not experienced any progression of their cancer. This is a Phase III trial, meaning it is in the later stages of testing to determine the effectiveness and safety of these treatments compared to a placebo.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with limited-stage small cell lung cancer (stage I-III).
  • Completed 4 cycles of chemotherapy along with radiation therapy within 1 to 42 days before starting the study treatment. The chemotherapy must include platinum and IV etoposide, and the radiation therapy should be either 60-66 Gy over 6 weeks or 45 Gy over 3 weeks.
  • Prophylactic cranial irradiation (PCI) may be given based on the doctor's decision and local practices, and must be completed 1 to 42 days before starting the study treatment.
  • Cancer has not progressed after completing chemoradiation therapy.
  • Expected to live at least 12 more weeks from the start of the study.
  • In good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have extensive-stage small cell lung cancer.
  • Have active or previously diagnosed autoimmune or inflammatory disorders.
  • Have uncontrolled illnesses, such as interstitial lung disease.
  • Have active infections, including tuberculosis, HIV, hepatitis B, or hepatitis C.
  • Have received chemotherapy and radiation therapy separately, without any overlap.

Locations

FACILITYZIPCITYSTATE
Research Site85715TucsonArizona
Research Site95403Santa RosaCalifornia
Research Site06510New HavenConnecticut
Research Site33901Fort MyersFlorida
Research Site32763Orange CityFlorida
Research Site33705St. PetersburgFlorida
Research Site30060MariettaGeorgia
Research Site60141HinesIllinois
Research Site46804Fort WayneIndiana
Research Site47303MuncieIndiana

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