Clinical Trials /

A Study of MTIG7192A in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03563716

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
AtezolizumabTecentriqMTIG7192A + atezolizumab
MTIG7192AMTIG7192A + atezolizumab
PlaceboPlacebo + 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

NameTypeDescriptionInterventions
MTIG7192A + atezolizumabExperimentalParticipants 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.
  • Atezolizumab
  • MTIG7192A
Placebo + atezolizumabPlacebo ComparatorParticipants 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.
  • Atezolizumab
  • Placebo

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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