Durvalumab for Early Stage Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if durvalumab, an immunotherapy, can reduce the recurrence of early-stage non-small cell lung cancer. Researchers will assess whether the number of cancer cells in the blood decreases after treatment with durvalumab, particularly in those who still show signs of cancer in their blood after standard treatments. This trial suits individuals who have had non-small cell lung cancer, completed initial treatments, and currently show no signs of cancer but have a blood test indicating possible lingering cancer cells. As a Phase 2 trial, this research focuses on evaluating the effectiveness of durvalumab in an initial, smaller group of participants, offering them a chance to contribute to significant findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on ongoing chronic treatment with systemic immunosuppressive medication, except for certain low-dose or specific types like inhaled corticosteroids.
Is there any evidence suggesting that durvalumab is likely to be safe for humans?
Research has shown that durvalumab is generally well-tolerated by people with non-small cell lung cancer (NSCLC). In past studies, many patients did not experience severe side effects. The most common side effects were mild, such as fatigue and cough. Serious side effects were less common but included lung infections and inflammation.
Other studies have found that durvalumab is safe for individuals who have undergone other lung cancer treatments. The FDA has approved it for certain types of NSCLC, supporting its safety. However, as with any medication, reactions can vary. Clinical trial participants will be closely monitored for any side effects.12345Why are researchers excited about this study treatment for lung cancer?
Durvalumab is unique because it offers a targeted immune-boosting approach for treating early-stage non-small cell lung cancer (NSCLC). Unlike traditional chemotherapy or radiation, which directly attack cancer cells, durvalumab is a type of immunotherapy that works by blocking the PD-L1 protein, helping the immune system identify and destroy cancer cells more effectively. Researchers are excited because this could enhance progression-free survival and overall survival rates for patients with minimal residual disease, offering a promising alternative to standard treatments.
What evidence suggests that durvalumab might be an effective treatment for early stage non-small cell lung cancer?
This trial will evaluate the effectiveness of durvalumab for early-stage non-small cell lung cancer (NSCLC). Studies have shown that durvalumab effectively treats NSCLC, helping to prevent the cancer from worsening after initial treatments. In patients with advanced NSCLC, durvalumab has been shown to shrink tumors and extend survival. Early findings also suggest that it works well when administered after other treatments, without causing unexpected side effects. Overall, durvalumab has shown promise in controlling cancer and improving survival rates. Participants in this trial will be divided into two cohorts: those with minimal residual disease positive (MRD+) will receive durvalumab, while those with minimal residual disease negative (MRD-) will receive standard care without durvalumab.14567
Who Is on the Research Team?
Joel W Neal, MD,PhD
Principal Investigator
Stanford Universiy
Are You a Good Fit for This Trial?
This trial is for adults over 18 with early-stage NSCLC who've completed surgery and/or radiation, possibly chemotherapy, but not immunotherapy. They must have no remaining cancer detectable except by ctDNA, be in good health with a life expectancy of at least 12 weeks, and agree to contraception. Those with certain mutations or other cancers under treatment can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants with detectable ctDNA (MRD+) receive up to 12 cycles of durvalumab, with ctDNA rechecked after 2 cycles
Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology