Ignite Creation Date:
2024-05-06 @ 12:41 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03823625
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2018-02-02
Brief Title:
An Open-label Randomized Parallel Non Comparative Phase II Trial of Nivolumab Plus Ipilimumab Versus Platinum-based Chemotherapy Plus Nivolumab in Chemonaive Metastatic or Recurrent Squamous-Cell Lung Cancer SqLC
Sponsor:
Fondazione Ricerca Traslazionale
Organization:
Fondazione Ricerca Traslazionale
Study Overview
Official Title:
SQUINT Squamous Immunotherapy Nivolumab-Ipilimumab Trial An Open-label Randomized Parallel Non Comparative Phase II Trial of Nivolumab Plus Ipilimumab Versus Platinum-based Chemotherapy Plus Nivolumab in Chemonaive Metastatic or Recurrent Squamous-Cell Lung Cancer SqLC
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SQUINT
Brief Summary:
Non-small-cell Lung Cancer NSCLC remains the leading cause of cancer death in Western Countries Approximately 85 of lung cancers are of the non-small-cell type NSCLC with 25-30 of NSCLC being squamous histology type Unlike nonsquamous NSCLC squamous NSCLC rarely harbors epidermal growth factor receptor EGFR and anaplastic lymphoma kinase ALK mutations for which there are directed therapies and until the recent approval of immunotherapies for pretreated squamous NSCLC a limited number of traditional cytotoxic chemotherapy drugs have been FDA-approved for use in the treatment of advanced and metastatic squamous NSCLC A platinum-based combination chemotherapy regimen has been the standard first-line treatment for all NSCLC Carboplatin is frequently substituted for cisplatin for patients who have poor renal function or who experience toxicities from cisplatin most notably nausea and vomiting Taxanes especially paclitaxel or vinorelbine or gemcitabine commonly complete the standard two-drug backbone of platinum-based chemotherapy for the first-line treatment of NSCLC with platin-gemcitabine as the most commonly used regimen in Europe in patients with squamous-histology A recent press release announced that pembrolizumab plus chemotherapy produced higher response rate when compared to chemotherapy alone in patients with squamous-cell lung cancer Nevertheless no data on Progression-Free Survival PFS and Overall Survival OS are available Therefore considering the lack of data in patients with squamous histology and the lack of information about efficacy of combinations of immune-checkpoints inhibitors versus immune-checkpoint inhibitor plus chemotherapy there is a strong rationale for conducting a study assessing efficacy of such strategies in patients with advanced metastatic squamous-cell lung cancer
Detailed Description:
Better understanding of the role of the immunological system in tumor control has opened multiple doors to implement different strategies to enhance immune response against cancer cells It is known that tumor cells elude immune response by several mechanisms The development of monoclonal antibodies against the checkpoint inhibitor programmed cell death protein 1 PD-1 and its ligand PD-L1 on T cells has led to high activity in cancer patients with long lasting responses In the KEYNOTE 024 the anti-PD-1 inhibitor Pembrolizumab significantly prolonged progression-free survival PFS and overall survival OS of patients with advanced NSCLC and high PD-L1 level 50 of tumor cells compared to platinum based chemotherapy thus becoming a new standard of care in front line setting However the trial was not restricted to squamous population with approximately 18 per arm having this histology Nivolumab another PD-1 inhibitor has been recently approved for the treatment of squamous cell lung cancer patients given the survival advantage demonstrated in a phase III trial comparing the drug to docetaxel in second-line setting Importantly the benefit produced by the drug was irrespective of PD-L1 expression suggesting that the high mutation burden of squamous-cell lung carcinoma is more relevant than the expression of a single biomarker at least in pretreated individuals In addition recent studies in chemo naive patients with non-squamous histology demonstrated that combination of chemotherapy and immunotherapy is superior to chemotherapy alone in terms of Overall Survival irrespective of PD-L1 expression Keynote 189 and IMPOWER 150 In addition the CheckMate 227 study recently showed that in chemonaive NSCLC combination of nivolumab and ipilimumab was superior to chemotherapy alone in patients with high tumor mutational burden TMB irrespective of PD-L1 expression A recent press release announced that pembrolizumab plus chemotherapy produced higher response rate when compared to chemotherapy alone in patients with squamous-cell lung cancer Keynote 407 Nevertheless no data on Progression-Free Survival and Overall Survival are available Therefore considering the lack of data in patients with squamous histology and the lack of information about efficacy of combinations of immune-checkpoints inhibitors versus immune-checkpoint inhibitor plus chemotherapy there is a strong rationale for conducting a study assessing efficacy of such strategies in patients with advanced metastatic squamous-cell lung cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None