Durvalumab + Tremelimumab with Chemotherapy for Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection will be eligible. Patients will receive standard platinum-based chemotherapy plus durvalumab for 4 cycles (every 3 weeks), followed by durvalumab (with or without pemetrexed for non-squamous NSCLC) maintenance therapy. It is hypothesized that Durvalumab and tremelimumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV infection.
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 must be on an effective HIV treatment for at least 4 weeks, and you cannot use immunosuppressive medications within 7 days before starting the trial, except for certain types of steroids.
What data supports the effectiveness of the drug combination of Durvalumab, Tremelimumab, and chemotherapy for non-small cell lung cancer?
The POSEIDON study showed that combining Durvalumab and Tremelimumab with chemotherapy significantly improved overall survival and progression-free survival in patients with metastatic non-small-cell lung cancer compared to chemotherapy alone. Additionally, a phase IB study reported a 51% objective response rate among non-small cell lung cancer patients treated with this combination, indicating promising anti-tumor activity.12345
Is the combination of Durvalumab and Tremelimumab with chemotherapy safe for humans?
The combination of Durvalumab and Tremelimumab with chemotherapy has been studied for safety in humans. Most side effects were mild to moderate, but some serious side effects like inflammation of the lungs (pneumonitis) and heart (myocarditis) were reported. There were also two treatment-related deaths in one study.12567
How is the drug combination of Durvalumab, Tremelimumab, and chemotherapy unique for treating non-small cell lung cancer?
This drug combination is unique because it combines immunotherapy agents Durvalumab and Tremelimumab with chemotherapy, aiming to enhance the immune system's ability to fight cancer while also using traditional chemotherapy to kill cancer cells. This approach has shown improved survival rates compared to chemotherapy alone in patients with metastatic non-small cell lung cancer.12345
Research Team
Chul Kim, MD
Principal Investigator
Georgetown University
Eligibility Criteria
This trial is for adults over 18 with stage IV Non-Small-Cell Lung Cancer and HIV, HBV, or HCV infections. They must have no prior systemic therapy for stage IV disease, be on effective anti-viral therapy if needed, and have an ECOG performance status of 0-2. Exclusions include brain radiation within the last 2 weeks, unresolved toxicity from previous cancer treatments (except hair loss), autoimmune disorders, CNS metastases or leptomeningeal disease, recent live vaccines, organ transplants, pregnancy/breastfeeding without birth control use.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive durvalumab and tremelimumab in combination with platinum-based chemotherapy for 4 cycles
Maintenance
Participants receive maintenance treatment with durvalumab (with or without pemetrexed for non-squamous NSCLC)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- Platinum-based Chemotherapy
- Tremelimumab
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?
Georgetown 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