Description:
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.
Title
- Brief Title: A Study of MTIG7192A in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Official Title: A Phase II, Randomized, Blinded, Placebo-Controlled Study of MTIG7192A, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
GO40290
- SECONDARY ID:
2018-000280-81
- NCT ID:
NCT03563716
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Atezolizumab | Tecentriq | MTIG7192A + atezolizumab |
MTIG7192A | | MTIG7192A + atezolizumab |
Placebo | | Placebo + atezolizumab |
Purpose
This study will evaluate the safety and efficacy of MTIG7192A 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.
Trial Arms
Name | Type | Description | Interventions |
---|
MTIG7192A + atezolizumab | Experimental | Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and MTIG7192A at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle. | |
Placebo + atezolizumab | Placebo Comparator | Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle. | |
Eligibility Criteria
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 hypercalcemia requiring continued use of
bisphosphonate therapy or denosumab
- 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
General Medical Exclusions:
- Pregnant and lactating women
- Significant cardiovascular disease
- Severe infections within 4 weeks prior to randomization
- Major surgical procedure other than for diagnosis within 4 weeks prior to
randomization
Treatment-Specific Exclusions:
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy
to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the
atezolizumab formulation
- History of autoimmune disease
- Prior allogeneic bone marrow transplantation or solid organ transplantation
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan
- Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or
hepatitis C or active tuberculosis
- Administration of a live, attenuated vaccine within 4 weeks prior to randomization
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | ORR, defined as a complete response or partial response on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1 |
Secondary Outcome Measures
Measure: | Duration of Objective Response (DOR) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | OS, defined as the time from randomization to death from any cause |
Measure: | Percentage of Participants With Adverse Events |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Serum concentrations of MTIG7192A or atezolizumab |
Time Frame: | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). |
Safety Issue: | |
Description: | |
Measure: | Perecentage of treatment-emergent anti-drug antibody-positive participants and anti-drug antibody-negative participants |
Time Frame: | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Genentech, Inc. |
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