SAPPHIRE
Research type
Research Study
Full title
A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)
IRAS ID
1003177
Contact name
Sanjay Kumar Popat
Contact email
Eudract number
2019-001043-41
Clinicaltrials.gov Identifier
Research summary
This is a study of an investigational (experimental) medication sitravatinib given in
combination with the immunotherapy nivolumab versus a single agent chemotherapy
docetaxel. Immunotherapy is treatment that uses the body’s own immune system to help
fight cancer. Chemotherapy is a treatment that includes a medication or combination of
medications that work throughout the body to help fight cancer. This study will compare
the effectiveness of sitravatinib in combination with nivolumab versus docetaxel in
participants 18 years of age or older with non-small cell lung cancer who have
previously had progression on or after chemotherapy and immunotherapy.
Eligible participants will be assigned to one of the treatments by chance. There is a 50%
chance of receiving sitravatinib combined with nivolumab and a 50% chance of receiving
chemotherapy docetaxel. Both participants and the study doctor will know what
treatment they are assigned to. Other objectives of the study include evaluating the safety
of sitravatinib in combination with nivolumab, assessing how quickly sitravatinib is
absorbed into the blood stream and how fast it is removed, and evaluating health-related
quality of life. Several laboratory tests will be performed using samples of tumour tissue
or blood to understand how and why the medications may work together in the treatment
of lung cancer. The tests performed on the tumour tissue sample is optional and not a
requirement of the study.
As many as 195 study sites globally and up to 532 patients are expected to participate in
this study. Participants will receive study treatment until disease progression,
unacceptable side effects or receipt of maximal number of cycles per local standard-ofcare,
study doctor decision or patient withdrawal. Patients experiencing clinical benefit
in the judgment of the study doctor may continue study treatment beyond disease
progression. Follow-up will be performed for this study.REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0077
Date of REC Opinion
14 Oct 2020
REC opinion
Further Information Favourable Opinion