Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC (NCT04925986) | Clinical Trial Compass
TerminatedPhase 2
Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC
Stopped: Sponsor decision based on data from other clinical trials
United States9 participantsStarted 2022-02-10
Plain-language summary
This is a multicohort phase 2 study to evaluate the efficacy of pembrolizumab combined with the investigational drug sitravatinib in the frontline treatment of advanced, non-squamous PD-L1 positive NSCLC.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
In order to be to be eligible to participate in this study, an individual must meet all of the following criteria:
* Histologically or cytologically confirmed non-squamous NSCLC that is metastatic (Stage IV), recurrent, or unresectable locally advanced (Stage IIIB/IIIC) disease, not amenable to treatment with curative intent.
* No prior systemic therapy for advanced disease. Prior chemotherapy for local or locally advanced disease is allowed if completed \>6 months prior to trial enrollment. Prior immunotherapy is not allowed.
* PD-L1 ≥ 1% using the 22c3 PD-L1 IHC assay or a local assay performed in a CLIA facility
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Life expectancy of at least 3 months.
* Measurable disease as per RECIST v1.1
* Adequate bone marrow and organ function demonstrated by:
* Absolute neutrophil count \>1,500/mm3 (1.5 × 10\^9/L).
* Hemoglobin ≥ 8.0 g/dL not dependent on transfusion support.
* Platelet count ≥ 75 × 10\^9/L (≥ 75,000 per mm3).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN without liver metastases; \< 5.0 x ULN if documented liver metastases
* Serum total bilirubin ≤ ULN, or for patients with potential Gilbert's, direct bilirubin ≤ ULN
* Calculated creatinine clearance ≥ 40 mL/min, using the Cockcroft-Gault formula.
* Women of child-bearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while part…