Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC
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|ClinicalTrials.gov Identifier: NCT03057106|
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : July 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Metastatic||Drug: Durvalumab Drug: Tremelimumab Drug: Platinum-Based Drug||Phase 2|
Combinations of durvalumab and tremelimumab have also been studied. While the combination has been studied in over 200 people, it is not clear if it can offer better results when it is combined with chemotherapy.
Recently, immunotherapies that target the PD-1/PD-L1 axis have shown promise in treating patients with non-small cell lung cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||February 15, 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Durvalumab and Tremelimumab
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Active Comparator: Platinum based chemotherapy + Durvalumab + Tremelimumab
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Drug: Platinum-Based Drug
Pemetrexed, cisplatin, carboplatin or gemcitibine
- Overall Survival [ Time Frame: 33 months ]time from randomization to the date of death
- Progression-free Survival using RECIST 1.1 [ Time Frame: 33 months ]time from randomization to the date of the first documented disease progression
- Objective Response Rate using RECIST 1.1 and iRECIST [ Time Frame: 33 months ]proportion of patients with a documented complete response, partial response (CR + PR) based on iRECIST criteria. The primary estimate of ORR will be based on all patients randomized, and compared using Cochran- Mantel-Haeszel test stratified by stratification factors at randomization between the study new treatment and the standard control arms.
- Number and Severity of Adverse Events [ Time Frame: 33 months ]using the NCI Common Terminology Criteria for Adverse Events Version 4.0. A Fisher's exact test will be used to compare adverse events between the study new treatment and the standard control arms if required.
- Cost Effectiveness of Durvalumab and Tremelimumab concurrently with combination chemotherapy [ Time Frame: 33 months ]The mean overall cost per patient for each of the two study treatment arms will be calculated to determine the addition cost per life-year gained.
- Correlate the expression of correlative markers with outcomes and response [ Time Frame: 33 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057106
|Contact: Francisco Vera-Badilloemail@example.com|
Show 46 Study Locations
|Study Chair:||Natasha Leighl||Princess Margaret Hospital, Toronto, ON Canada|