Tiragolumab With Atezolizumab Plus Bevacizumab in Previously-Treated Advanced Non-squamous NSCLC

NCT04958811 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00003943
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the efficacy of tiragolumab with atezolizumab and bevacizumab in previously-treated advanced non-squamous NSCLC.

Conditions

Non-squamous Non-small-cell Lung Cancer

Keywords

Lung Cancer; Non-squamous Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  As defined by investigator-assessed ORR according to RECIST v1.1

  Up to end of treatment (average 9 months)

Secondary Outcomes (5)

• Incidence of Treatment-Related Adverse Events

  At the end of each cycle of therapy (every ~21 days)

• Progression Free Survival (PFS)

  Up to 5 years

• 6-month PFS rate

  Up to 5 years

• Duration of Response (DOR)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

Study Arms (1)

Tiragolumab plus atezolizumab and bevacizumab

EXPERIMENTAL

Tiragolumab 600mg IV will be administered together with atezolizumab 1200mg IV and bevacizumab 15mg/kg IV every 3 weeks (q3w) until progressive disease or unacceptable toxicity.

Drug: Tiragolumab; Drug: Atezolizumab; Drug: Bevacizumab

Interventions

Tiragolumab DRUG

600mg IV administered every 3 weeks.

Tiragolumab plus atezolizumab and bevacizumab

Atezolizumab DRUG

1200mg IV administered every 3 weeks.

Tiragolumab plus atezolizumab and bevacizumab

Bevacizumab DRUG

15mg/kg IV administered every 3 weeks.

Tiragolumab plus atezolizumab and bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form (ICF)
• Age ≥ 18 years at time of signing ICF
• Ability to comply with the study protocol, in the investigator's judgment
• Histologically or cytologically confirmed advanced non-squamous NSCLC that is not amenable to definitive therapy
• Tumor PD-L1 expression (TPS ≥ 1%) (cohort A only)
• EGFR, ALK, ROS1 wild-type (cohort A only)
• Confirmed activating alteration in EGFR (cohort B only)
• Disease progression during or following treatment with anti-PD(L)1 containing therapy (cohort A only)
• Disease progression during or following treatment with appropriate EGFR targeted therapy (cohort B only)
• Measurable disease per RECIST v1.1
• Biopsy post-progression on anti-PD(L)1 (cohort A) or EGFR targeted therapy (cohort B) confirming non-squamous histology prior to study treatment initiation
• ECOG Performance Status of 0-2
• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
• ANC ≥ 1.0 x 10\^9/L without granulocyte colony-stimulating factor support
• Lymphocyte count ≥ 0.5 x 10\^9/L

You may not qualify if:

• Prior treatment with anti-TIGIT antibody therapy
• Prior treatment with anti-PD(L)1 therapeutic antibodies for advanced NSCLC (cohort B only)
• Untreated or symptomatic CNS metastases
• History of leptomeningeal disease
• Active or history of clinically significant autoimmune disease that, in the opinion of the investigator, could compromise the health and safety of the patient if treated with investigational therapy. Notable exceptions include:
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone.
• Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen.
• Active or history of adrenal insufficiency on stable steroid regimen.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: disease is well controlled at baseline and requires only low-potency topical corticosteroids; no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Known active tuberculosis
• Current treatment with anti-viral therapy for HBV
• Positive EBV viral capsid antigen antibody (IgM) testing at screening. An EBV PCR test should be performed as clinically indicated to screen for acute infection or suspected chronic active infection. Patients with a positive EBV PCR test are excluded.
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
• History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death as assessed and confirmed by the study PI. Possible examples include: adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Sponsors & Collaborators

• Georgetown University: lead
• Genentech, Inc.: collaborator

Study Sites (2)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tiragolumab; atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joshua Reuss, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 12, 2021
• Study Start: December 21, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (2)