Tiragolumab and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and… (NCT05746481) | Clinical Trial Compass
TerminatedPhase 2
Tiragolumab and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases
Stopped: Decision by agent provider
United States3 participantsStarted 2023-08-10
Plain-language summary
This clinical trial is aimed at the evaluation of the safety and clinical activity of tiragolumab in combination with atezolizumab with or without chemotherapy in the first line treatment of metastatic non-squamous NSCLC patients with asymptomatic untreated brain metastases.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed non-squamous NSCLC.
* In patients treated with the combination of tiragolumab and atezolizumab, patients must have PDL1 TPS \>50%, as determined by an FDA-approved test.
* Patients must have asymptomatic brain metastases with at least one untreated evaluable (per RANO-BM) brain metastasis of 5 mm or more. A growing lesion previously treated with whole brain radiotherapy is acceptable given the lower incidence of radiation necrosis. Lesions previously treated with SRS may not be used as target lesions.
o Patients are not required to have measurable disease outside the CNS per RECIST 1.1.
* Prior chemotherapy, immunotherapy or radiation given with curative intent in early stage or locoregionally advanced NSCLC is permitted, if completed more than 12 months prior to initiation of study treatment.
* Prior radiation with palliative intent in the metastatic setting to non-CNS lesions is permitted (no wash-out period).
* Age ≥18 years.
* ECOG performance status ≤ 1.
* Life expectancy ≥12 weeks.
* Patients must have normal organ and marrow function as defined below:
* Absolute neutrophil count ≥1,500/mcL
* Platelets ≥100,000/mcL
* Total bilirubin ≤ institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
* Creatinine Clearance (CrCl) ≥45 mL/min/1.73 m2
* No known history of HIV, with the following exception: patients who are HIV positive are eligible provi…
What they're measuring
1
Rate of Initiation of Salvage Radiation Therapy to Central Nervous System (CNS)