Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor

NCT03977467 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MULTI 29
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Phase II, two part trial (A and B), open label study of Atezolizumab and tiragolumab, or atezolizumab combined with SOC chemotherapy in patients with NSCLC or advanced solid tumors that have had prior treatment with a PD-1 inhibitor (e.g. nivolumab or pembrolizumab).

Conditions

Non-Small Cell Lung Cancer; Solid Tumor

Keywords

atezolizumab; NSCLC; Non-Small Cell Lung Cancer; advanced solid tumors; tiragolumab

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to the immune-modified RECIST criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.

  Every 8 weeks until tumor progression or treatment discontinuation, up to 52 months.

Secondary Outcomes (2)

• Incidence of Treatment-emergent Adverse Events (AEs) as a Measure of Safety

  Every 3 weeks, up to 52 months

• Disease Control Rate (DCR)

  Every 8 weeks until tumor progression or treatment discontinuation, up to 52 months.

Study Arms (4)

Arm A1 (NSCLC Chemo + Atezolizumab)

EXPERIMENTAL

Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.

Drug: Atezolizumab; Drug: Standard of Care Chemotherapy

Arm B (Atezolizumab only)

EXPERIMENTAL

In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.

Drug: Atezolizumab

Arm A2 (NSCLC Standard of Care Chemo)

ACTIVE COMPARATOR

Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.

Drug: Standard of Care Chemotherapy

Arm B (Atezolizumab and Tiragolumab)

EXPERIMENTAL

In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.

Drug: Atezolizumab; Drug: Tiragolumab

Interventions

Atezolizumab DRUG

Atezolizumab at a flat dose of 1200 mg IV every 3 weeks

Also known as: TECENTRIQ

Arm A1 (NSCLC Chemo + Atezolizumab); Arm B (Atezolizumab and Tiragolumab); Arm B (Atezolizumab only)

Standard of Care Chemotherapy DRUG

Platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. It should be administered according to the directions in the approved labeling.

Arm A1 (NSCLC Chemo + Atezolizumab); Arm A2 (NSCLC Standard of Care Chemo)

Tiragolumab DRUG

Tiragolumab at a flat dose of 600 mg IV every 3 weeks

Arm B (Atezolizumab and Tiragolumab)

Eligibility Criteria

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

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 - 2
• Adequate hematologic function defined as:
• \- Absolute neutrophil count (ANC) ≥1500/μL with one exception: Patients with benign ethnic neutropenia (BEN): ANC \>1300/ μL
• \- Lymphocyte count ≥0.5 × 109/L (500/µL)
• Hemoglobin (Hgb) ≥9 g/dL (patients may be transfused to meet this criterion)
• Platelets ≥100,000/µL (without transfusion, within 7 days of enrollment)
• Adequate liver function defined as:
• \- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN)
• \- Total bilirubin ≤1.5 x ULN (patients with known Gilbert syndrome: serum bilirubin level ≤ 3 x ULN)
• Adequate renal function defined as serum creatinine ≤1.5 mg/dL (133 μmol/L) or calculated creatinine clearance ≥30 mL/min as calculated by the Cockcroft Gault formula
• For patients not receiving therapeutic anticoagulation: INR or aPTT ≤1.5 × ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \<1% per year, during their participation in the study and for 5 months following last dose of study drug(s).
• \- A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
• \- Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.
• Male patients with a female partner of childbearing potential or a pregnant female partner must remain abstinent (refrain from heterosexual intercourse) or use a condom must also refrain from donating sperm during the treatment period and for 5 months after the last dose of study drug. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal or post-ovulation methods) and withdrawal are not adequate methods of contraception. Men must also refrain from donating sperm during their participation in the study

You may not qualify if:

• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• History of any Grade 3 or 4 toxicities to a prior CPI treatment
• Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulations
• Most recent immunotherapy ≤21 days and ≥ Grade 2 immunotherapy-related side effects, with the exception of alopecia.
• Use of systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) ≤28 days or 5 half-lives (whichever is shorter) prior to the first dose of study drugs.
• Treatment with chemotherapy in the first line setting.7. Treatment with investigational therapy within 28 days prior to initiation of study treatment.
• \. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions:
• Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
• Patients who received mineralocorticoids (e.g., fludrocortisone), inhaled corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
• \. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of atezolizumab or tiragolumab 10. Uncontrolled tumor-related pain 11. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment.
• Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
• \. Requirement for use of denosumab during the study. Patients who are receiving denosumab for any reason (including hypercalcemia) must be willing and eligible to receive a bisphosphonate instead while in the study.
• \. Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
• \. Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
• \. Symptomatic, untreated, or actively progressing CNS metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy. Anticonvulsant therapy at a stable dose is permitted.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Genentech, Inc.: collaborator

Study Sites (7)

Florida Cancer Specialists - South

Fort Myers, Florida, 33991, United States

Location

Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists - Panhandle

Tallahassee, Florida, 32308, United States

Location

Florida Cancer Specialists - East

West Palm Beach, Florida, 33401, United States

Location

MidAmerica Division, Inc., c/o Research Medical Center (HCA Midwest)

Kansas City, Missouri, 64132, United States

Location

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; Tiragolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Sarah Cannon Development Innovations, LLC
• Organization: Sarah Cannon Development Innovations, LLC

SCRI.InnovationsMedical@scri.com

844-710-6157

Study Officials

• Melissa Johnson, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 6, 2019
• Study Start: August 30, 2019
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Locations

US (7)