Testing the Addition of AZD6738 to Immunotherapy to Extend Cancer-Free Time in Non-Small Cell Lung Cancer Patients

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06732401

Provider View

This study is exploring whether adding the drug AZD6738 to the immunotherapy drug durvalumab can help patients with non-small cell lung cancer stay cancer-free for longer after chemotherapy and surgery.

Patient Parameters

Program Overview

This phase III clinical trial is investigating if combining AZD6738 with durvalumab can extend the time patients with non-small cell lung cancer remain cancer-free after receiving chemotherapy and surgery. AZD6738 may help stop tumor growth by blocking certain enzymes, while durvalumab is an antibody that helps prevent cancer cells from growing and spreading. The study aims to see if this combination is more effective than using durvalumab alone.

Description

The main goal of this study is to see if adding AZD6738 to durvalumab improves the time patients remain free of cancer after surgery and chemotherapy, compared to using durvalumab alone. Researchers will also look at overall survival rates and how different factors like cancer stage and previous treatments affect outcomes.

Participants will be randomly assigned to one of two groups:

  • Group A: Starting 4-12 weeks after surgery, patients will receive durvalumab through an IV every 28 days for up to 12 cycles, unless the cancer progresses or side effects become too severe. Regular CT scans and blood tests will be conducted.

  • Group B: Starting 4-12 weeks after surgery, patients will take AZD6738 pills twice daily for 7 days and receive durvalumab through an IV on the 8th day of each 28-day cycle, for up to 12 cycles. Regular CT scans and blood tests will be conducted.

After completing the treatment, patients will have follow-up visits every 12 weeks for 2 years, then every 24 weeks until 5 years, and annually until 10 years from the start of the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have stage II to select stage IIIB non-small cell lung cancer.
  • Planning to undergo, currently undergoing, or recently completed standard chemo-immunotherapy and surgery.
  • Must have completed at least 3 cycles of chemo-immunotherapy before surgery.
  • Must have had surgery within a timeframe that allows starting the study treatment 4-12 weeks after surgery.
  • Must not have a complete response to treatment before surgery.
  • Must have a good performance status (ECOG 0-2).
  • Must not have certain genetic mutations (EGFR or ALK).
  • Must have a chest CT scan after surgery.
  • Must have recovered from any significant side effects of previous treatments.
  • Must not be on high-dose steroids or have a history of certain lung diseases.
  • Must not be pregnant or breastfeeding and must agree to use effective contraception.
  • Must have adequate blood counts and organ function.
  • Must not have received a live vaccine recently.
  • Must be able to understand and sign a consent form.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.