Personalized Treatment After Chemoradiotherapy and Immunotherapy for Stage III Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Maximilian Diehn

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04585490

Provider View

This study is exploring whether adding the drugs Tremelimumab and extra chemotherapy to the standard treatment can reduce the number of cancer cells in the blood for patients with Stage III NSCLC.

Patient Parameters

Program Overview

The study aims to find out if combining the standard treatment (durvalumab) with Tremelimumab and additional chemotherapy can lower the number of circulating cancer cells in the blood for patients with Stage III NSCLC. Researchers will measure changes in cancer cell DNA levels in the blood to see if this approach is effective.

Description

The main goal of this study is to see if adding Tremelimumab and extra chemotherapy to the standard treatment can reduce the levels of cancer cell DNA in the blood for patients with Stage III NSCLC. This is especially for those whose cancer cannot be removed by surgery and who have already received chemotherapy and radiation.

Secondary goals include:

  • Determining how many patients have undetectable cancer cell DNA after the additional treatment.
  • Comparing overall survival and progression-free survival between patients with detectable and undetectable cancer cell DNA at the start of the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with locally-advanced, unresectable Stage III NSCLC or recurrent NSCLC after previous treatment.
  • Completed platinum-based chemotherapy and radiation therapy without disease progression.
  • Currently receiving durvalumab as part of the treatment plan.
  • Able to receive additional chemotherapy and Tremelimumab.
  • Pre-treatment tumor tissue or DNA sample available for analysis.
  • Aged 18 years or older and weigh more than 30 kg.
  • Life expectancy of at least 12 weeks.
  • Good overall health with specific blood counts and organ function within normal ranges.
  • Willing to sign informed consent.

Exclusion Criteria

  • Involvement in planning or conducting the study.
  • Previously participated in this study or received investigational products in another study.
  • Mixed small cell and non-small cell lung cancer.
  • Currently undergoing active treatment for another primary cancer, except for certain cases.
  • Use of immunosuppressive medication within 14 days before enrollment, with some exceptions.
  • Unresolved side effects from previous treatment, except for certain conditions.
  • History of severe immune-related side effects from previous immunotherapy.
  • Recent major surgery that would prevent study participation.
  • Active or prior autoimmune or inflammatory disorders that could limit treatment.
  • History of primary immunodeficiency or organ transplant requiring immunosuppression.
  • Allergies to certain chemotherapy drugs.
  • Active infections, including Hepatitis B, Hepatitis C, tuberculosis, or HIV.
  • Recent receipt of live vaccines.
  • Uncontrolled illnesses or conditions that could interfere with the study.
  • Pregnant or breastfeeding women, or those not using effective birth control.

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