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Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.

Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.

Tiragolumab

Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.

Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.

Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.

Jennifer Ruth, RN, BSN

Danielle Bednarz, RN, BSN

Jennifer Ruth, RN

Liza Villaruz, MD

Liza C Villaruz, MD

This clinical trial is aimed at the evaluation of the safety and clinical activity of tiragolumab in combination with carboplatin, pemetrexed and atezolizumab in the first line treatment of metastatic non-squamous NSCLC patients with asymptomatic untreated brain metastases.

This is a phase II clinical trial aimed at the evaluation of the safety and clinical activity of tiragolumab in combination with carboplatin, pemetrexed and atezolizumab in the first line treatment of metastatic non-squamous NSCLC patients with asymptomatic untreated brain metastases. Patients with at least one untreated evaluable brain metastasis of 5 mm or more will be enrolled. Lesions previously treated with SRS may not be used as target lesions. Patients will be required to undergo an on-treatment brain MRI at three weeks for safety purposes. Additional restaging will occur at nine-week intervals. PD-L1 tumor proportion score (TPS) will be determined utilizing an FDA-approved test by local testing.

Carboplatin, Pemetrexed, and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases

A Phase II Clinical Trial of Tiragolumab in Combination With Carboplatin, Pemetrexed, and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases

The proportion of patients that require salvage radiation therapy to the CNS (within 18 weeks from study initiation). Salvage radiation therapy is radiation treatment given for suspected recurrent malignant disease.

Adverse Events and Serious Adverse Events per Common Terminology Criteria for Adverse Events CTCAE v5.0, at least possibly related to trial treatment.

Proportion of patients with brain metastases that experience a Complete or Partial Response per RANO-BM. RANO Criteria: Complete Response (CR):disappearance of all enhancing disease (measurable and non-measurable), sustained for at least 4 weeks, stable or improved non-enhancing FLAIR/T2W lesions, no new lesions; clinical features - no corticosteroids (physiological replacement doses allowed) clinically stable or improved. Partial Response (PR): 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks no progression of non-measurable disease stable or improved non-enhancing FLAIR/T2W lesions no new lesions; clinical features stable or reduced corticosteroids (compared to baseline) clinically stable or improved.

The proportion of participants experiencing Complete or Partial Response assessed using RECIST v1.1. Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

The length of time during and after treatment that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

The length of time from start of treatment that patients remain still alive.

The length of time during and after treatment and after after initiation of salvage radiation therapy (XRT) that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Tumor Proportion Score (TPS) indicates protein expression by measuring the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS ≥ 1% and high PD-L1 expression if TPS ≥ 50%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Carboplatin, Pemetrexed, and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases	NCT05746481	Non-small Cell ...	Tiragolumab Atezolizumab Pemetrexed Carboplatin	18 Years -	University of Pittsburgh
Carboplatin, Pemetrexed, and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases	NCT05746481	Non-small Cell ...	Tiragolumab Atezolizumab Pemetrexed Carboplatin	18 Years -	University of Pittsburgh

Spots Global Cancer Trial Database for salvage radiation therapy