Quick Start Durvalumab After Chemoradiation for Stage III Non-Small Cell Lung Cancer

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05696782

Provider View

This study is exploring the effects of starting Durvalumab treatment quickly, within 14 days after finishing chemotherapy and radiation, for patients with Stage III non-small cell lung cancer. It also looks at any challenges in starting Durvalumab early.

Patient Parameters

Program Overview

The aim of this research is to find out how starting Durvalumab treatment soon after chemotherapy and radiation affects patients with Stage III non-small cell lung cancer. Researchers want to see if starting Durvalumab within 14 days of finishing other treatments is beneficial and what obstacles might exist in doing so.

Description

The main goal of this study is to see how well patients can start Durvalumab treatment early, within 14 days after finishing radiation therapy, for Stage III non-small cell lung cancer that cannot be removed by surgery.

Other goals include:

  • Seeing if starting Durvalumab even earlier, within 7 days after radiation, is possible.
  • Identifying any challenges to starting Durvalumab early after chemotherapy and radiation.
  • Comparing the side effects of starting Durvalumab quickly to past cases.
  • Evaluating how effective Durvalumab is when started quickly compared to past cases.
  • Understanding how patients feel about starting Durvalumab quickly after their other treatments.

Eligibility Criteria

Inclusion Criteria

  • Must have Stage III non-small cell lung cancer confirmed by medical tests.
  • Cancer cannot be removed by surgery or surgery is not an option.
  • Must have completed or be undergoing radiation therapy for lung cancer, or plan to start it soon.
  • Must have completed or be undergoing platinum-based chemotherapy for lung cancer, or plan to start it soon.
  • Plan to receive Durvalumab after radiation and chemotherapy.
  • Must be 18 years or older.
  • Must be in good general health, with a performance status score of 0 to 2.
  • Must have a life expectancy of more than three months.
  • Must use contraception if there is a chance of pregnancy during the study.
  • Must understand and agree to sign a consent form to participate.

Exclusion Criteria

  • Have uncontrolled breathing problems or symptoms affecting daily life.
  • Cancer has worsened during radiation therapy.
  • Cancer has a specific mutation that responds to certain first-line treatments.
  • Have previously received certain immune therapies.
  • Have an active autoimmune disease needing treatment with immunosuppressants.
  • Have a history of lung inflammation needing high-dose steroids.
  • Have uncontrolled illnesses like infections, heart failure, or mental health issues that affect study participation.
  • Are pregnant or breastfeeding.

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