Description:
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.
Title
- Brief Title: 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: 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
Clinical Trial IDs
- ORG STUDY ID:
GO42501
- SECONDARY ID:
2020-002853-11
- NCT ID:
NCT04832854
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
Interventions
Drug | Synonyms | Arms |
---|
Atezolizumab | Tecentriq | Cohort A (PD-L1 High) |
Tiragolumab | MTIG7192A | Cohort A (PD-L1 High) |
Carboplatin | | Cohort A (PD-L1 High) |
Cisplatin | | Cohort A (PD-L1 High) |
Pemetrexed | | Cohort A (PD-L1 High) |
Gemcitabine | | Cohort A (PD-L1 High) |
Paclitaxel | | Cohort A (PD-L1 High) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort A (PD-L1 High) | Experimental | 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 | - Atezolizumab
- Tiragolumab
- Carboplatin
- Cisplatin
- Pemetrexed
- Gemcitabine
- Paclitaxel
|
Cohort B (PD-L1 All Comers) | Experimental | 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 | - Atezolizumab
- Tiragolumab
- Carboplatin
- Cisplatin
- Pemetrexed
- Gemcitabine
- Paclitaxel
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants With Surgical Delays |
Time Frame: | Up to approximately 6 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Percentage of Participants With Pathological Complete Response (pCR) |
Time Frame: | At the time of surgery (approximately Weeks 17-20) |
Safety Issue: | |
Description: | |
Measure: | 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) |
Safety Issue: | |
Description: | |
Measure: | 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) |
Safety Issue: | |
Description: | |
Measure: | 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) |
Safety Issue: | |
Description: | |
Measure: | 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) |
Safety Issue: | |
Description: | |
Measure: | 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) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Hoffmann-La Roche |
Last Updated
August 25, 2021