Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC

Sponsor
Canadian Cancer Trials Group
Study ID
NCT03057106
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    MEDI4736
  • Tremelimumab — DRUG
    Tremelimumab
  • Platinum-Based Drug — DRUG
    Pemetrexed, cisplatin, carboplatin or gemcitibine

Study Details

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.

Key Dates

Start date
Mar 28, 2017
Status verified
Feb 2026
Primary completion
Feb 24, 2020
Completion
Jun 30, 2026

Study Design

Enrollment
301 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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) Followed by: Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD

Primary Outcome Measure

Overall Survival [ Time Frame: 33 months ]

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