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Trial record 1 of 1 for:    NCT04832854
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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

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ClinicalTrials.gov Identifier: NCT04832854
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 2, 2021
First Posted Date  ICMJE April 6, 2021
Last Update Posted Date November 4, 2021
Actual Study Start Date  ICMJE April 23, 2021
Estimated Primary Completion Date February 28, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2021)
  • Number of Participants With Surgical Delays [ Time Frame: Up to approximately 6 years ]
  • Number of Participants With Operative and Post-operative Complications [ Time Frame: Up to approximately 6 years ]
  • Number of Participants With Surgical Cancellations Related to Study Treatment [ Time Frame: Up to approximately 6 years ]
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 6 years ]
  • Percentage of Participants Who Achieve Major Pathological Response (MPR) [ Time Frame: At the time of surgery (approximately Weeks 17-20) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2021)
  • Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: At the time of surgery (approximately Weeks 17-20) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer (NSCLC)
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Atezolizumab
    • Drug: Tiragolumab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Pemetrexed
    • Drug: Gemcitabine
    • Drug: Paclitaxel
  • 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
    Interventions:
    • Drug: Atezolizumab
    • Drug: Tiragolumab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Pemetrexed
    • Drug: Gemcitabine
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2021)
82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2027
Estimated Primary Completion Date February 28, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GO42501 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Spain,   Switzerland,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT04832854
Other Study ID Numbers  ICMJE GO42501
2020-002853-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP