Durvalumab + Chemoradiation for Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that you should not have received chemotherapy or radiotherapy within 4 weeks prior to registration, and you must not be on systemic immunosuppressive medications within 7 days prior to registration. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Durvalumab in treating non-small cell lung cancer?
Research shows that adding Durvalumab to chemoradiation improves disease control and survival in patients with locally advanced non-small cell lung cancer. The PACIFIC trial found that Durvalumab significantly increased overall survival and progression-free survival compared to a placebo, with a manageable safety profile.12345
Is durvalumab safe for humans?
Durvalumab, also known as MEDI4736 or Imfinzi, has shown a manageable safety profile in treating various cancers, including non-small cell lung cancer. It is generally well-tolerated, but treatment-related side effects can occur, especially when combined with other therapies like chemotherapy or radiotherapy.13467
What makes the drug Durvalumab unique for treating non-small cell lung cancer?
Durvalumab is unique because it is used after chemoradiation to improve survival in patients with locally advanced non-small cell lung cancer, and it works by enhancing the immune system's ability to fight cancer cells. This combination of immunotherapy with chemoradiation is a newer approach that has shown better disease control and survival rates compared to traditional treatments.128910
Research Team
Nathan A Pennell
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
Adults with stage IIIA/B/C non-small cell lung cancer that can't be surgically removed, or those with nodal recurrence after early-stage surgery. Participants must not have lost more than 10% of their weight unintentionally in the last month, should use effective contraception, and have no severe allergies to antibodies or history of certain infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Concurrent Therapy
Patients receive durvalumab and chemotherapy with radiation therapy for 6 weeks
Consolidation Therapy
Patients receive durvalumab every 28 days for 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor