301 Participants Needed

Durvalumab + Tremelimumab ± Chemotherapy for Lung Cancer

Recruiting at 48 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Canadian Cancer Trials Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

NL

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

I am fully active or restricted in physically strenuous activity but can do light work.
Patients must have an adequate histopathology specimen and must consent to release this specimen for protocol required testing. This is a mandatory component of the study.
My liver function tests are within the required range.
See 22 more

Exclusion Criteria

I have no allergies to durvalumab, tremelimumab, or their ingredients, and I've managed previous cancer treatments without severe reactions or needing steroids.
My heart's electrical activity (QTcF) is normal or I don't have a family history of long QT syndrome.
Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol, or would put the patient at risk.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Durvalumab and Tremelimumab with or without platinum-based chemotherapy

12 weeks
4 visits (in-person)

Maintenance

Participants receive maintenance therapy with Durvalumab or Pemetrexed + Durvalumab until disease progression

Until disease progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

33 months

Treatment Details

Interventions

  • Durvalumab
  • Platinum-Based Drug
  • Tremelimumab
Trial Overview The study is testing Durvalumab and Tremelimumab immunotherapies, alone or combined with platinum-based chemotherapy. These drugs help the immune system recognize and fight cancer cells. The trial will assess their effectiveness in slowing down cancer growth compared to standard treatments.
Participant Groups
2Treatment groups
Active Control
Group I: Durvalumab and TremelimumabActive Control2 Interventions
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Group II: Platinum based chemotherapy + Durvalumab + TremelimumabActive Control3 Interventions
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles) Followed by: Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺
Approved in European Union as Imfinzi for:
  • Locally advanced, unresectable non-small cell lung cancer (NSCLC)
🇺🇸
Approved in United States as Imfinzi for:
  • Extensive-stage small cell lung cancer (ES-SCLC)
  • Limited-stage small cell lung cancer (LS-SCLC)
  • Locally advanced or metastatic urothelial carcinoma
🇯🇵
Approved in Japan as Imfinzi for:
  • Not specified in provided sources

Find a Clinic Near You

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials
135
Recruited
70,300+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

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

Trials
203
Recruited
166,000+

National Health and Medical Research Council, Australia

Collaborator

Trials
167
Recruited
473,000+

Findings from Research

In the phase 3 POSEIDON study involving 1013 treatment-naïve patients with metastatic non-small-cell lung cancer (NSCLC), the combination of tremelimumab, durvalumab, and chemotherapy significantly improved overall survival and progression-free survival compared to chemotherapy alone.
Patients receiving the combination treatment also experienced a longer time to deterioration in quality of life and various symptoms, indicating better overall health status compared to those on chemotherapy, supporting its use as a first-line treatment option.
Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON).Garon, EB., Cho, BC., Luft, A., et al.[2023]
Tremelimumab, a CTLA-4 blocking antibody, was approved in the USA in October 2022 for treating unresectable hepatocellular carcinoma (uHCC) in combination with durvalumab, marking a significant advancement in cancer therapy.
In November 2022, tremelimumab was also approved for metastatic non-small cell lung cancer (mNSCLC) when combined with durvalumab and platinum-based chemotherapy, indicating its broad potential in treating various malignant tumors.
Tremelimumab: First Approval.Keam, SJ.[2023]
Durvalumab is an FDA-approved monoclonal antibody that enhances T-cell responses against cancer by blocking the PD-L1 pathway, specifically for patients with advanced urothelial carcinoma who have progressed after platinum-based chemotherapy.
The drug is currently being tested in phase III trials for various cancers, including lung and head and neck cancers, indicating its potential broad application in oncology beyond urothelial carcinoma.
Durvalumab: First Global Approval.Syed, YY.[2022]

References

Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON). [2023]
Tremelimumab: First Approval. [2023]
Durvalumab: First Global Approval. [2022]
Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC). [2022]
Tremelimumab. [2023]
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis. [2023]
A phase IB study of durvalumab with or without tremelimumab and platinum-doublet chemotherapy in advanced solid tumours: Canadian Cancer Trials Group Study IND226. [2021]
Durvalumab for the treatment of non-small cell lung cancer. [2019]
Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security