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A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04832854
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (NSCLC). The study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: Atezolizumab Drug: Tiragolumab Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Drug: Gemcitabine Drug: Paclitaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
Actual Study Start Date : April 23, 2021
Estimated Primary Completion Date : April 30, 2028
Estimated Study Completion Date : April 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A (PD-L1 High)

Participants with high programmed death-ligand 1 (PD-L1) expression level will be enrolled in Cohort A and receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical resection and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator.

Chemotherapy may include:

  • cisplatin/carboplatin + pemetrexed (for non-squamous only)
  • cisplatin/carboplatin + gemcitabine (for squamous only)
  • carboplatin + paclitaxel
 Drug: Atezolizumab
Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Name: Tecentriq

Drug: Tiragolumab
Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
Other Name: MTIG7192A

Drug: Carboplatin
Carboplatin at initial target area under the concentration curve (AUC) of 5 or 6 mg/mL/min will be administered by IV infusion on Day 1 of each 21-day cycle.

Drug: Cisplatin
Cisplatin at 75 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Drug: Pemetrexed
Pemetrexed at 500 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Drug: Gemcitabine
Gemcitabine at 1000 or 1250 mg/m^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.

Drug: Paclitaxel
Paclitaxel at 175 or 200 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
Experimental: Cohort B (PD-L1 All Comers)

All comers, which are participants with any PD-L1 expression level, will be enrolled in Cohort B and receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles.

Chemotherapy may include:

  • cisplatin/carboplatin + pemetrexed (for non-squamous only)
  • cisplatin/carboplatin + gemcitabine (for squamous only)
  • carboplatin + paclitaxel
 Drug: Atezolizumab
Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Name: Tecentriq

Drug: Tiragolumab
Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
Other Name: MTIG7192A

Drug: Carboplatin
Carboplatin at initial target area under the concentration curve (AUC) of 5 or 6 mg/mL/min will be administered by IV infusion on Day 1 of each 21-day cycle.

Drug: Cisplatin
Cisplatin at 75 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Drug: Pemetrexed
Pemetrexed at 500 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Drug: Gemcitabine
Gemcitabine at 1000 or 1250 mg/m^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.

Drug: Paclitaxel
Paclitaxel at 175 or 200 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Surgical Delays [ Time Frame: Up to approximately 6 years ]
  2. Number of Participants With Operative and Post-operative Complications [ Time Frame: Up to approximately 6 years ]
  3. Number of Participants With Surgical Cancellations Related to Study Treatment [ Time Frame: Up to approximately 6 years ]
  4. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 6 years ]
  5. Percentage of Participants Who Achieve Major Pathological Response (MPR) [ Time Frame: At the time of surgery (approximately Weeks 17-20) ]

Secondary Outcome Measures :
  1. Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: At the time of surgery (approximately Weeks 17-20) ]
  2. Event Free Survival (EFS) [ Time Frame: From baseline to disease progression that precludes surgical resection, or local or distant disease recurrence after surgery, or death from any cause (up to approximately 6 years) ]
  3. Serum Concentrations of Atezolizumab [ Time Frame: Day 1 of Cycle 1 (cycle=21 days): pre-dose and 30 minutes (min) post-dose; Day 1 of Cycles 2, 3, 4, 5, 8, 12, 16: pre-dose; at treatment discontinuation (TD) visit (up to approximately 9 months) ]
  4. Serum Concentrations of Tiragolumab [ Time Frame: Day 1 of Cycle 1 (cycle=21 days): pre-dose and 30 min post-dose; Day 1 of Cycles 2, 3, 4, 5, 8, 12, 16: pre-dose; at TD visit (up to approximately 9 months) ]
  5. Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12 and 16 (cycle=21 days) and at TD visit (up to approximately 9 months) ]
  6. Percentage of Participants With ADAs to Tiragolumab [ Time Frame: Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12 and 16 (cycle=21 days) and at TD visit (up to approximately 9 months) ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria:

  • Histologically or cytologically confirmed Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology
  • Eligible for R0 resection with curative intent at the time of screening
  • Adequate pulmonary function to be eligible for surgical resection with curative intent
  • Eligible to receive a platinum-based chemotherapy regimen
  • Measurable disease, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Availability of a representative tumor specimen that is suitable for determination of PD-L1 status
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Normal life expectancy, excluding lung cancer mortality risk
  • Adequate hematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test at screening
  • Negative serology for active hepatitis B virus (HBV) and active hepatitis C virus (HCV) at screening

Key Exclusion Criteria:

  • NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC not otherwise specified
  • Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC
  • Any prior therapy for lung cancer
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Active tuberculosis
  • Significant cardiovascular disease
  • NSCLC with an activating EGFR mutation or ALK fusion oncogene
  • Known c-ros oncogene 1 (ROS1) rearrangement
  • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with negligible risk of metastasis or death
  • Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
  • Prior treatment with CD127 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents
  • Treatment with systemic immunosuppressive medication
  • Pregnancy or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832854


Contacts
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Contact: Reference Study ID Number: GO42501 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04832854    
Other Study ID Numbers: GO42501
2020-002853-11 ( EudraCT Number )
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Gemcitabine
Pemetrexed
 Atezolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Immune Checkpoint Inhibitors
Antineoplastic Agents, Immunological