This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone (Atezo + Tira) or in combination with platinum-based chemotherapy (Atezo + Tira + Chemo) as neoadjuvant treatment for patients with previously…
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
Safety:
- To evaluate the safety of Atezo + Tira as neoadjuvant treatment followed by
either Atezo + Tira or Chemo as adjuvant treatment
- To evaluate the safety of Atezo + Tira + Chemo as neoadjuvant treatment
followed by Atezo + Tira as adjuvant treatment.
Primary Efficacy
- To evaluate the efficacy of Atezo + Tira or Atezo + Tira + Chemo as
neoadjuvant treatment
Secondary outcome
Efficacy
- To evaluate the efficacy of Atezo + Tira or Atezo + Tira + Chemo as
neoadjuvant treatment
- To evaluate the efficacy of Atezo + Tira as neoadjuvant treatment followed by
either Atezo + Tira or Chemo as adjuvant treatment
- To evaluate the efficacy of Atezo + Tira + Chemo as neoadjuvant treatment
followed by Atezo + Tira as adjuvant treatment
Background summary
Non-small cell lung cancer (NSCLC) is the predominant subtype of lung cancer.
The overall 5-year survival rate for advanced disease (Stage IVA and IVB) is
0%-10%, Poor prognostic factors for survival in patients with NSCLC include
advanced stage of disease at the time of initial diagnosis, poor performance
status, and a history of unintentional weight loss. More than one-half of
patients with NSCLC are diagnosed with metastatic disease, which directly
contributes to poor survival prospects.
In light of the evidence of clinical activity of atezolizumab plus tiragolumab
in NSCLC and the need to improve survival and decrease recurrence rates for
patients with resectable early-stage NSCLC, the Sponsor is conducting this
Phase II study GO42501.The study is designed to evaluate whether
neoadjuvant therapy with the combination of atezolizumab and tiragolumab, with
or without platinum-based chemotherapy, is safe and tolerable and does not have
a deleterious effect on surgical outcomes in patients with resectable Stage II,
IIIA, and select IIIB (T3N2) NSCLC. This study is also designed to evaluate
potential anti-tumor effects of neoadjuvant atezolizumab plus tiragolumab alone
(Cohort A) or with platinum-based chemotherapy (Cohort B), as measured by MPR.
Refer to section 1 of the protocol for a more elaborate background and study
rationale.
Study objective
This study will evaluate the surgical safety and feasibility of atezolizumab
plus tiragolumab alone (Atezo + Tira) or in combination with platinum-based
chemotherapy (Atezo + Tira + Chemo) as neoadjuvant treatment for patients with
previously untreated locally advanced NSCLC. The study will also evaluate the
efficacy, pharmacokinetics, immunogenicity, and safety of neoadjuvant Atezo +
Tira or Atezo + Tira + Chemo, followed by adjuvant Atezo + Tira or adjuvant
platinum-based chemotherapy (Chemo).
Study design
This is a global Phase II, open-label, multicenter study evaluating the safety
and efficacy of neoadjuvant and adjuvant atezolizumab plus tiragolumab, with or
without platinum-based chemotherapy, in patients with previously untreated,
histologically or cytologically confirmed resectable Stage II, IIIA, or select
IIIB (T3N2 only) NSCLC.
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
Patients will be assigned to a cohort on the basis of PD-L1 status as outlined
in the protocol section 4.2.1 and will receive treatment as follows:
- Cohort A (PD-L1 high): neoadjuvant Atezo + Tira for 4 cycles, followed by
surgical resection and either adjuvant Atezo + Tira for 16 cycles or adjuvant
chemotherapy for 4 cycles
- Cohort B (PD-L1 all comers): neoadjuvant Atezo + Tira + Chemo for 4 cycles,
followed by surgical resection and adjuvant Atezo + Tira for 16 cycles
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 3446AA
NL
Beneluxlaan 2A
Woerden 3446AA
NL
Listed location countries
Age
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, as
confirmed by the operating attending surgeon and involved medical oncologist
prior to study enrollment;
• Adequate pulmonary function to be eligible for surgical resection;
• Measurable disease, as assessed by the investigator per RECIST v1.1;
• Adequate tumor tissue for PD-L1 assessment;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Adequate hematologic and end-organ function;
• Negative HIV test at screening;
• Negative for active hepatitis B and hepatitis C at screening.
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, or idiopathic pneumonitis, or evidence of active pneumonitis;
• 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 a negligible risk of metastasis or
death;
• Severe infection within 4 weeks prior to initiation of study treatment;
• Treatment with investigational therapy within 42 days prior to initiation of
study treatment;
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic
antibodies;
• Pregnant or lactating women.
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 |
|---|---|
| EudraCT | EUCTR2020-002853-11-NL |
| CCMO | NL79744.056.21 |