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NCT03906071

Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Data source: WHO (Imported from 18.01.2022)
Changed: 18.01.2022
Disease category:

Health conditions (Data source: WHO)

Metastatic Non-Squamous Non-Small Cell Lung Cancer

Interventions (Data source: WHO)

Biological: Nivolumab;Drug: Sitravatinib;Drug: Docetaxel

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Diagnosis of Non-Squamous Non-Small Cell Lung Cancer

- Receipt of at least one but not more than two prior treatment regimens in the advanced
setting

- Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based
chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy
followed by checkpoint inhibitor therapy)

- Most recent treatment regimen must have included a checkpoint inhibitor therapy with
radiographic disease progression on or after treatment

- Candidate to receive docetaxel as second or third line therapy

Exclusion Criteria:

- Uncontrolled brain metastases

- Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions

- Unacceptable toxicity with prior checkpoint inhibitor therapy

- Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than
maintenance chemotherapy

- Impaired heart function

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03906071

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03906071

Further information on trial

Date trial registered

04.04.2019

Incorporation of the first participant

15.07.2019

Recruitment status

Recruiting

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Overall Survival (OS)

Secundary end point (Data source: WHO)

Adverse Events (AEs);Objective Response Rate (ORR);Progression-Free Survival (PFS)

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

Ronald L. Shazer, MD, MBA;Mirati Therapeutics Study Locator Services
Mirati Therapeutics Inc.
1-844-893-5530 (toll free)
miratistudylocator@emergingmed.com

Contact for scientific information (Data source: WHO)

Ronald L. Shazer, MD, MBA;Mirati Therapeutics Study Locator Services
Mirati Therapeutics Inc.
1-844-893-5530 (toll free)
miratistudylocator@emergingmed.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Mirati Therapeutics Inc.

Additional sponsors (Data source: WHO)

Bristol-Myers Squibb

Further trial identification numbers

Secondary ID (Data source: WHO)

516-005