This study has been transitioned to CTIS with ID 2022-502482-17-00 check the CTIS register for the current data. This study will evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in patients…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-PFS after randomization, defined as the time from randomization to the first
occurrence of disease progression or death from any cause (whichever occurs
first), as determined by the investigator according to RECIST v1.1, in the
primary analysis set
-OS after randomization, defined as the time from randomization to death from
any cause, in the primary analysis set
Secondary outcome
1. Investigator assessed PFS according to RECIST v1.1 in the secondary analysis
set
2. Investigator assessed OS according to RECIST v1.1 in the secondary analysis
set
3.Confirmed ORR, defined as the proportion of patients with a complete response
(CR) or partial response (PR) on two consecutive occasions > 4 weeks apart, as
determined by the investigator according to RECIST v1.1
4.DOR for patients with confirmed ORR, defined as the time from the first
occurrence of a documented objective response to disease progression or death
from any cause (whichever occurs first), as determined by the investigator
according to RECIST v1.1
5.PFS rate at 6 months and 12 months, defined as the proportion of patients who
have not experienced disease progression or death from any cause at 6 months
and 12 months respectively, as determined by the investigator according to
RECIST v1.1
6.OS rate at 12 months and 24 months, defined as the proportion of patients who
have not experienced death from any cause at 12 and 24 months, respectively
7.Time to sustained deterioration (TTSD) in patient-reported physical
functioning and global health status, as measured by the European Organisation
for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for
Cancer (QLQ-C30)
8. Incidence and severity of adverse events, with severity determined
according to the National Cancer Institute Common Terminology Criteria for
Adverse Events, Version 5.0
9. Minimum serum concentration (Cmin) and Maximum serum concentrate (Cmax) of
tiragolumab
10. Cmin and Cmax of atezolizumab
11. Prevalence of ADAs to tiragolumab and atezolizumab at baseline and during
the study.
Background summary
Clinical data emerging in the field of tumor immunotherapy have demonstrated
that therapies focused on enhancing T-cell responses against cancer can result
in a significant survival benefit in patients with metastatic cancer,
including NSCLC. PD-L1/PD-1 inhibitors in the 1L and 2L-plus settings have
demonstrated significant improvement in survival compared with standard
chemotherapy, which has led to the recent approvals of these agents for the
treatment of NSCLC and validates the inhibition of the PD-L1/PD-1 pathway for
achieving clinical benefit in NSCLC. Furthermore, the safety profile of PD-L1
and PD-1 antibodies as monotherapy appears to be more tolerable than many of
the chemotherapy doublet combinations given in the front-line setting, which
are associated with substantial toxicities and are often poorly tolerated by
elderly and patients with poor performance status.
The results from the Phase II GO40290 study provide rationale to further
evaluate the combination of tiragolumab and atezolizumab as a 1L treatment for
NSCLC in a larger Phase III study. Therefore, this study (GO41717) is designed
to evaluate whether the anti-tumor effects of atezolizumab, as measured by PFS
and OS, may be improved with the addition of the anti-TIGIT antibody
tiragolumab compared with placebo plus atezolizumab in patients with previously
untreated, locally advanced or metastatic NSCLC
Study objective
This study has been transitioned to CTIS with ID 2022-502482-17-00 check the CTIS register for the current data.
This study will evaluate the efficacy and safety of tiragolumab plus
atezolizumab compared with placebo plus atezolizumab in patients with
previously untreated locally advanced, unresectable or metastatic PD-L1
selected NSCLC, with no EGFR mutation or ALK translocation.
Study design
This is a Phase III, randomized, double-blinded, placebo-controlled, global,
multicenter study designed to evaluate the efficacy, safety, of tiragolumab
plus atezolizumab compared with placebo plus atezolizumab in patients with
previously untreated locally advanced, unresectable or metastatic PD-L1
selected NSCLC.
After a screening period, eligible patients will be in a randomized 1:1 ratio
to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
Please refer to figure 1 and appendix 1 in the protocol, where the study design
is shown and the schedule of assessments is provided respectively.
Intervention
In the experimental arm, patients will receive atezolizumab at a fixed dose of
1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle, followed
by tiragolumab at a fixed dose of 600 mg administered to patients by IV
infusion Q3W on Day 1 of each 21-day cycle.
In the control arm, patients will receive atezolizumab at a fixed dose of 1200
mg administered by IV infusion Q3W on Day 1 of each 21-day cycle, followed by
placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Study burden and risks
The general burden for the patient consists of (a.o.) the withdrawal of blood
samples, possible collection of tumor sample, administration of investigational
products (intravenously) which may lead to various adverse events.
Beneluxlaan 2A
Woerden 3446GR
NL
Beneluxlaan 2A
Woerden 3446GR
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Histologically or cytologically documented locally advanced or recurrent
NSCLC
- No prior systemic treatment for metastatic NSCLC
- Tumor PD-L1 expression as determined by PD-L1 IHC assay TPS >= 50% as
determined by 22C3 pharmaDx assay TC3 or IC3 as determined by the VENTANA PD-L1
Assay (SP142), or TC >= 50% as determined by the investigational VENTANA PD-L1
CDx Assay (SP263) of tumor tissue
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version
1.1 (RECIST v1.1)
- Adequate hematologic and end-organ function.
Exclusion criteria
- Known to have a mutation in the EGFR gene or an ALK fusion oncogene
- Symptomatic, untreated, or actively progressing central nervous system
metastases
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Significant cardiovascular disease
- History of malignancy other than NSCLC within 5 years prior to screening,
with the exception of malignancies with a negligible risk of metastasis or death
- Severe infection within 4 weeks prior to initiation of study treatment
- Current treatment with anti-viral therapy for HBV or HCV
- Treatment with investigational therapy within 28 days prior to initiation of
study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- Treatment with systemic immunostimulatory agents or anticipation of need for
systemic immunosuppressive medication during study treatment prior to
initiation of study treatment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2022-502482-17-00 |
| EudraCT | EUCTR2019-002925-31-NL |
| CCMO | NL72441.056.20 |