A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB AND TIRAGOLUMAB COMPARED WITH DURVALUMAB IN PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER WHO HAVE NOT PROGRESSED AFTER CONCURRENT PLATINUM-BASED CHEMORADIATION.
- Conditions
- 10029107lung cancerNon-small cell lung cancer10038666
- Registration Number
- NL-OMON54439
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 21
Age>= 18 years
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Histologically or cytologically documented NSCLC with locally advanced
unresectable Stage III NSCLC of either squamous or non-squamous histology
- Whole-body PET-CT scan for the purposes of staging, performed prior and
within 42 days of the first dose of concurrent chemoradiotherapy (CRT)
- At least two prior cycles of platinum-based chemotherapy concurrent with
radio therapy (cCRT), which must be completed within 1 to 42 days prior to
randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
- The RT component in the CRT must have been at a total dose of radiation of
60 Gy±10% (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy
(preferred) or 3D-conforming technique
- No progression during or following concurrent platinum-based CRT
- Tumor PD-L1 expression, as determined by the investigational Ventana PD-L1
(SP263) CDx assay and documented by means of central testing of a
representative tumor tissue, in either a previously obtained archival tumor
tissue or fresh tissue obtained from a biopsy collected prior to the first dose
of cCRT
- Adequate hematologic and end-organ function.
- Any history of prior NSCLC - NSCLC known to have a mutation in the epidermal
growth factor mutation and/or an anaplastic lymphoma kinase translocation - Any
evidence of Stage IV disease - Treatment with sequential CRT for locally
advanced NSCLC - Patients with locally advanced NSCLC who have progressed
during or after the definitive concurrent CRT prior to randomization - Any
Grade > 2 unresolved toxicity from previous CRT - Grade >=2 pneumonitis from
prior CRT - Active or history of autoimmune disease or immune deficiency,
history of idiopathic pulmonary fibrosis, organizing pneumonia - History of
malignancy other than NSCLC within 5 years prior to screening - Severe
infection within 4 weeks prior to initiation of study treatment, including, but
not limited to, hospitalization for complications of infection, bacteremia, or
severe pneumonia, or any active infection that, in the opinion of the
investigator, could impact patient safety - Prior allogeneic stem cell or solid
organ transplantation - Active Epstein-Barr virus (EBV) infection or known or
suspected chronic active EBV infection at screening - Treatment with
investigational therapy within 28 days prior to initiation of study treatment -
Prior treatment with CD137 agonists or immune checkpoint blockade therapies -
Any prior Grade >= 3 immune-mediated adverse event or any unresolved Grade > 1
immune-mediated adverse event while receiving any previous immunotherapy agent
other than immune checkpoint blockade agents - Current treatment with
anti-viral therapy for hepatitis B virus or hepatitis C virus - Prior treatment
with CD137 agonists or immune checkpoint blockade therapies, including
anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor
with Ig and ITIM domains, anti-PD-1, and anti-PD-L1 therapeutic antibodies -
Treatment with systemic immunosuppressive medication (including, but not
limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate,
thalidomide, and anti-tumor necrosis factor-[antiTNF-alpha]agents) within 2
weeks prior to initiation of study treatment, or anticipation of need for
systemic immunosuppressivemedication during study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To evaluate the efficacy of tiragolumab plus atezolizumab compared with<br /><br>durvalumab with durvalumab in the programmed death ligand 1 positive analysis<br /><br>set (PPAS) on the basis of PFS, as assessed by an IRF as assessed by an<br /><br>independent review facility (IRF)<br /><br><br /><br><br /><br>- To evaluate the efficacy of tiragolumab plus atezolizumab compared with<br /><br>durvalumab in the programmed death ligand 1 positive analysis set<br /><br>(PPAS) on the basis of PFS, as assessed by an IRF.</p><br>
- Secondary Outcome Measures
Name Time Method