Durvalumab + Tremelimumab ± Chemotherapy for Lung Cancer
Trial Summary
What is the purpose of this trial?
Durvalumab is a new type of drug for many kinds of cancer. It is considered "immunotherapy" and not "chemotherapy". Laboratory tests show that it works by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals and has been studied in more than 5000 people and seems promising. Tremelimumab is a new type of drug for various types of cancers. It works in a similar way to durvalumab and may improve the effect of durvalumab. Tremelimumab may also help slow the growth of the cancer cells or may cause cancer cells to die. It has been shown to shrink tumours in animals and has been studied in over 1200 people and seems promising.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have received certain prior treatments like cytotoxic chemotherapy for advanced disease or immune-based therapies. It's best to discuss your current medications with the trial team to ensure they don't conflict with the study requirements.
What data supports the effectiveness of the drug combination of Durvalumab and Tremelimumab with or without chemotherapy for lung cancer?
The POSEIDON study showed that using tremelimumab and durvalumab with chemotherapy improved survival and slowed disease progression in patients with metastatic non-small-cell lung cancer compared to chemotherapy alone. Additionally, this combination has been approved in the USA for treating metastatic non-small cell lung cancer, indicating its effectiveness.12345
Is the combination of Durvalumab and Tremelimumab safe for humans?
The combination of Durvalumab and Tremelimumab has been studied for safety in various cancers, including lung cancer. Common side effects include diarrhea, reduced appetite, and skin issues, with some serious side effects like pneumonitis (lung inflammation) and myocarditis (heart inflammation) reported. While most side effects are mild, there have been rare cases of treatment-related deaths.23678
What makes the drug combination of Durvalumab and Tremelimumab with chemotherapy unique for lung cancer?
This treatment combines Durvalumab, which enhances the immune system's ability to fight cancer by blocking a protein called PD-L1, with Tremelimumab, another immune-boosting drug, and chemotherapy. This combination has shown improved survival rates in patients with metastatic non-small-cell lung cancer compared to chemotherapy alone, offering a novel approach by targeting the immune system alongside traditional chemotherapy.13789
Research Team
Natasha Leighl
Principal Investigator
Princess Margaret Hospital, Toronto, ON Canada
Eligibility Criteria
Adults with stage IV non-small cell lung cancer (NSCLC), either squamous or non-squamous, who haven't had prior immune therapy or certain other treatments. They must have good organ function, no serious illnesses that could interfere with the trial, and not be pregnant. Participants need to agree to use effective contraception and complete quality of life questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Durvalumab and Tremelimumab with or without platinum-based chemotherapy
Maintenance
Participants receive maintenance therapy with Durvalumab or Pemetrexed + Durvalumab until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- Platinum-Based Drug
- 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?
Canadian Cancer Trials Group
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
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborator
National Health and Medical Research Council, Australia
Collaborator