Study on Local Therapy and Durvalumab for Stage III Non-Small Cell Lung Cancer with Limited or Multiple Progressions After Chemoradiation and Anti-PD-L1 Therapy

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04892953

Provider View

This clinical trial is exploring the effects of combining local treatments like surgery or radiation with the immunotherapy drug durvalumab in patients with stage III non-small cell lung cancer (NSCLC) that has shown limited or multiple progressions after initial treatments.

Patient Parameters

Program Overview

The purpose of this study is to determine if using local treatments such as surgery or radiation, along with the immunotherapy drug durvalumab, can help control stage III non-small cell lung cancer (NSCLC) that has either a few (3 or fewer) or many (more than 3) areas of progression after initial chemoradiation and anti-PD-L1 therapy. Local treatments aim to eliminate remaining cancer cells, while durvalumab may boost the immune system to prevent cancer growth and spread.

Description

This study is divided into two groups based on the number of cancer progressions:

  • Group A (Oligoprogressive): Patients with 3 or fewer progressing cancer areas will receive local treatments like surgery or radiation, followed by durvalumab given through an IV every 28 days, as long as the cancer does not worsen or cause severe side effects.

  • Group B (Polyprogressive): Patients with more than 3 progressing cancer areas will receive local treatments, durvalumab, and additional chemotherapy. Chemotherapy options include carboplatin and paclitaxel, carboplatin and nab-paclitaxel, or carboplatin and gemcitabine, given in cycles every 21 days for 4 cycles. Patients with non-squamous cancer types will also receive pemetrexed.

The study aims to compare the effectiveness of these treatments in extending the time patients live without cancer progression and overall survival, as well as assess the quality of life and safety of the treatments. Researchers will also analyze tumor and blood samples to study biomarkers and the microbiome.

After completing the study treatment, patients will have follow-up visits every 12 weeks for 2 years to monitor their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent and follow study requirements.
  • Diagnosed with stage III non-small cell lung cancer (NSCLC) that has progressed or persisted after standard chemoradiation and durvalumab therapy.
  • For lung adenocarcinoma patients, must not have certain genetic mutations for which other treatments are available.
  • For Group A: 3 or fewer progressing cancer areas.
  • For Group B: More than 3 progressing cancer areas.
  • Eligible for radiation therapy to at least one cancer area.
  • Recent tumor assessment with CT or PET-CT and MRI of the brain.
  • Aged 18 years or older.
  • Good overall health with an ECOG performance status of 0-1.
  • Body weight over 30 kg.
  • Adequate blood counts and organ function as determined by specific tests.
  • Willing to comply with study procedures and have a life expectancy of at least 12 weeks.

Exclusion Criteria

  • Rapid progression on previous treatment with chemoradiotherapy and durvalumab.
  • Treated with other anti-PD-(L)1 therapies besides durvalumab.
  • Participation in another clinical study with an investigational product in the last 4 weeks.
  • Recent anticancer therapy within 28 days before starting the study drug, except for durvalumab.
  • Unresolved severe side effects from previous cancer treatments.
  • Concurrent cancer treatments not part of the study protocol.
  • Major surgery within 28 days before starting the study drug.
  • History of organ transplantation or certain autoimmune or inflammatory disorders.
  • Uncontrolled illnesses or infections.
  • History of another primary cancer unless treated and inactive for 3 years.
  • Brain metastases not treated or stable.
  • Heart conditions affecting study participation.
  • Active infections like tuberculosis or hepatitis.
  • Recent use of immunosuppressive medications.
  • Recent receipt of live vaccines.
  • Pregnant or breastfeeding individuals or those not using effective birth control.
  • Allergies to study drugs or components.
  • Previous severe side effects from similar immunotherapies.

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