AN OPEN, MULTICENTER PHASE II STUDY TO ASSESS THE SAFETY AND EFFICACY OF NEOADJUVANT AND ADJUVANT THERAPY OF TIRAGOLUMAB PLUS ATEZOLOZUMAB WITH OR WITHOUT PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OPERABLE NON-SMALL CELL LUNG CANCER STAGE II, IIIA OR A SPECIFIC FORM IN STAGE IIIB
Summary description of the study
The aim of this study is to assess the effects, whether positive or negative, of Tecentriq (Atezolizumab) and Tiragolumab with or without chemotherapy in patients whose lung cancer can be surgically removed. It aims to find out whether and/or how long these treatments can help prevent the return of cancer. This study will be conducted in multiple countries and trial centers. Approximately 82 patients will participate in this study. In this study, patients will receive either Tecentriq and Tiragolumab with or without chemotherapy depending on the amount of PD-L1 (programmed-death ligand 1; a specific receptor on tumor cells that is important for interaction with immune cells) on the surface of the tumor. Before the surgery to remove the tumor, visits to the study center will occur approximately every 3 weeks for about 12 weeks. Depending on the treatment arm, patients may continue to receive Tecentriq and Tiragolumab for up to 48 weeks after surgery, with visits every 3 weeks to the study center to receive the study treatment and assess their health status, or patients will receive chemotherapy for up to 12 weeks, with visits every 3 weeks to the study center to receive the study treatment and assess their health status. Additionally, patients will come to the study center for tumor imaging to assess whether their cancer has returned. These visits will occur every 4 months in the first year after surgery and then every 6 months in years 2-5 after surgery. After the last treatment dose, follow-up visits will be conducted approximately every 6 months for the rest of the patient's life or until the study is terminated.
(BASEC)
Intervention under investigation
The combination therapy to be investigated in this study consists of Tecentriq and Tiragolumab, administered with or without chemotherapy. In this study, the chemotherapy will be a combination of either Paclitaxel with Carboplatin, Pemetrexed with Carboplatin or Cisplatin, or Gemcitabine with Carboplatin or Cisplatin. Tecentriq is a type of medication known as a PD-L1 antagonist and represents a form of cancer immunotherapy. It helps your immune system recognize and fight cancer cells. Tecentriq is approved in several countries for the treatment of advanced urothelial carcinoma, a form of bladder cancer, as well as some types of lung cancer that have spread to other parts of the body and for which surgery is not an option. However, in this study, Tecentriq is considered an experimental drug, meaning that health authorities have not approved Tecentriq either alone or in combination with Tiragolumab, with or without chemotherapy, for the treatment of operable NSCLC at stages II, IIIA, or Select IIIB. Tiragolumab is a cancer immunotherapy that works by blocking and neutralizing the Tigit protein. Tigit is a protein on human immune cells that can allow tumor cells to escape the immune system. Tiragolumab may help strengthen your immune system and stop or reverse tumor growth. Tiragolumab (also known as anti-Tigit antibody) is an experimental drug, meaning that health authorities have not approved Tiragolumab for the treatment of NSCLC. Tiragolumab has been tested in previous studies involving more than 250 individuals with advanced cancer.
(BASEC)
Disease under investigation
This clinical study is for patients with operable non-small cell lung cancer (NSCLC) at an early stage.
(BASEC)
- Histologically or cytologically confirmed stage II, IIIA or Select IIIB (only T3N2) NSCLC of squamous cell histology or non-squamous cell histology according to UICC/AJCC 8 - Eligible for R0 resection (lung cancer that can be completely surgically removed) at the time of examination - Availability of a representative tumor sample suitable for determining PD-L1 status through central testing (BASEC)
Exclusion criteria
- Lung cancer with a mutation in the EGFR gene and/or ALK gene and/or ROS1 gene - Any disease or medication that would interfere with the interpretation of the study, affect any study drug, or increase safety risks for patients - Any prior therapy for lung cancer including immunotherapy, chemotherapy, or radiation therapy (BASEC)
Trial sites
Basel, Bern, Chur, St. Gallen, Winterthur, Zurich, Other
(BASEC)
Baden
(BASEC)
Sponsor
Roche Pharma (Schweiz) AG
(BASEC)
Contact
Contact Person Switzerland
Clinical Trials
+41 61 715 43 91
switzerland.clinical-research@clutterroche.comRoche Pharma (Schweiz) AG
(BASEC)
General Information
Hoffmann-La Roche
(ICTRP)
Scientific Information
Hoffmann-La Roche
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
01.02.2021
(BASEC)
ICTRP Trial ID
NCT04832854 (ICTRP)
Official title (approved by ethics committee)
GO42501: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 (BASEC)
Academic 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 (ICTRP)
Public 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 (ICTRP)
Disease under investigation
Non-Small Cell Lung Cancer (NSCLC) (ICTRP)
Intervention under investigation
Drug: AtezolizumabDrug: TiragolumabDrug: CarboplatinDrug: CisplatinDrug: PemetrexedDrug: GemcitabineDrug: Paclitaxel (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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 (ICTRP)
not available
Primary and secondary end points
Number of Participants With Surgical Delays;Number of Participants With Operative and Post-operative Complications;Number of Participants With Surgical Cancellations Related to Study Treatment;Number of Participants With Adverse Events (AEs);Major Pathological Response (MPR) Rate (ICTRP)
Percentage of Participants With Pathological Complete Response (pCR);Event-free Survival (EFS);Serum Concentrations of Atezolizumab at Specified Timepoints;Serum Concentrations of Tiragolumab at Specified Timepoints;Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab;Percentage of Participants With ADAs to Tiragolumab (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Clinical Trials, Hoffmann-La Roche (ICTRP)
Secondary trial IDs
2020-002853-11, GO42501 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT04832854 (ICTRP)
Results of the trial
Results summary
lps-go42501-final-results-september-2025-english-fr-ch.pdfLink to the results in the primary register
not available