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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04832854




Registration number
NCT04832854
Ethics application status
Date submitted
2/04/2021
Date registered
6/04/2021

Titles & IDs
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
Scientific 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
Secondary ID [1] 0 0
2020-002853-11
Secondary ID [2] 0 0
GO42501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Paclitaxel

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)
* carboplatin + gemcitabine (for squamous only)
* carboplatin + 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)
* carboplatin + gemcitabine (for squamous only)
* carboplatin + paclitaxel


Treatment: Drugs: Atezolizumab
Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Treatment: Drugs: Tiragolumab
Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.

Treatment: Drugs: 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.

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

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

Treatment: Drugs: 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.

Treatment: Drugs: Paclitaxel
Paclitaxel at 175 or 200 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Surgical Delays
Timepoint [1] 0 0
Up to approximately 6 years
Primary outcome [2] 0 0
Number of Participants With Operative and Post-operative Complications
Timepoint [2] 0 0
Up to approximately 6 years
Primary outcome [3] 0 0
Number of Participants With Surgical Cancellations Related to Study Treatment
Timepoint [3] 0 0
Up to approximately 6 years
Primary outcome [4] 0 0
Percentage of Participants With Adverse Events
Timepoint [4] 0 0
Up to approximately 6 years
Primary outcome [5] 0 0
Percentage of Participants Who Achieve Major Pathological Response (MPR)
Timepoint [5] 0 0
At the time of surgery (approximately Weeks 17-20)
Secondary outcome [1] 0 0
Percentage of Participants With Pathological Complete Response (pCR)
Timepoint [1] 0 0
At the time of surgery (approximately Weeks 17-20)
Secondary outcome [2] 0 0
Event Free Survival (EFS)
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Serum Concentrations of Atezolizumab
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Serum Concentrations of Tiragolumab
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Percentage of Participants With ADAs to Tiragolumab
Timepoint [6] 0 0
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
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital; The Adem Crosby Centre - Birtinya
Recruitment hospital [2] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [3] 0 0
PETER MACCALLUM CANCER INSTITUTE; MEDICAL ONCOLOGY; Parkville Cancer Clinical Trials Unit - Melbourne
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Gyeonggi-do
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
LA Coruña
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Switzerland
State/province [10] 0 0
Baden
Country [11] 0 0
Switzerland
State/province [11] 0 0
Chur
Country [12] 0 0
Switzerland
State/province [12] 0 0
St. Gallen
Country [13] 0 0
Switzerland
State/province [13] 0 0
Winterthur
Country [14] 0 0
Switzerland
State/province [14] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04832854