A Study to Assess Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 1

Conditions: MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]
on-small cell lung cancer (NSCLC)

Registration Number: CTIS2023-508083-30-00

Lead Sponsor: Genentech Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

No prior systemic treatment for locally advanced unresectable or metastatic NSCLC, Tumor PD-L1 expression on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening, Confirmed availability of representative tumor specimens, along with an associated pathology report, Measurable disease as defined by RECIST v1.1, Life expectancy =12 weeks, Adequate hematologic and end-organ function

Exclusion Criteria

Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene, Patients with the pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC, Symptomatic, untreated, or actively progressing CNS metastases, Spinal cord compression not definitively treated with surgery and/or radiation, History of leptomeningeal disease, Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab, as measured by objective response rate (ORR) and progression-free survival (PFS);Secondary Objective: 1. To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab, as measured by duration of objective response (DOR) and overall survival (OS), 2. To evaluate the safety and tolerability of tiragolumab plus atezolizumab compared with placebo plus atezolizumab, 3. To characterize the pharmacokinetic (PK) profile of tiragolumab and atezolizumab, 4. To evaluate the immune response to tiragolumab and atezolizumab;Primary end point(s): 1. ORR as determined by the investigator according to RECIST v1.1, 2. PFS as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):1. DOR as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first;Secondary end point(s):2. Overall survival;Secondary end point(s):3. Incidence, nature, and severity of adverse events, graded according to the NCI CTCAE v4.0;Secondary end point(s):4. Clinically significant changes from baseline in vital signs, physical findings, and clinical laboratory results;Secondary end point(s):5. Serum concentrations of tiragolumab or atezolizumab at specified timepoints;Secondary end point(s):6. Incidence of treatment-emergent Anti-drug antibodies (ADAs) and their potential impact on safety, efficacy, and pharmacokinetics