A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Local… (NCT03563716) | Clinical Trial Compass
CompletedPhase 2
A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
United States135 participantsStarted 2018-08-10
Plain-language summary
This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* ECOG Performance Status of 0 or 1
* Histologically or cytologically documented locally advanced unresectable NSCLC, recurrent, or metastatic NSCLC of either squamous or non-squamous histology
* No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
* Tumor PD-L1 expression
* Measurable disease, as defined by RECIST v1.1
* Life expectancy \>=12 weeks
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria:
Cancer-Specific Exclusions:
* Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to screening
* History of leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia or symptomatic hypercalcemi…
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months)
2
Progression-free Survival (PFS)
Timeframe: From baseline until a total of 80 PFS events have occurred (up to approximately 11 months)