NCT03823625: SQUINT

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 Phase 2 Last updated 25 March 2020

What this trial tests

Phase 2 trial testing Nivolumab plus Ipilimumab in Squamous-Cell Lung Cancer in 112 participants. Status unknown.

Timeline

13 September 2017

Primary endpoint
28 February 2021

28 February 2021

Quick facts

Lead sponsor	Fondazione Ricerca Traslazionale
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	112
Start date	13 September 2017
Primary completion	28 February 2021
Estimated completion	28 February 2021
Sites	18 locations across Italy

Drugs / interventions tested

• Nivolumab plus Ipilimumab (nivolumab-plus-ipilimumab) — full drug profile →
• Platinum-based chemotherapy plus Nivolumab — full drug profile →

Conditions studied

• Squamous-Cell Lung Cancer — all drugs for Squamous-Cell Lung Cancer →

Sponsor

Fondazione Ricerca Traslazionale — full company profile →

Who can join

18 and older, any sex, with Squamous-Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The emerging treatment landscape of targeted therapy in non-small-cell lung cancer.
   Yuan M, Huang LL, Chen JH, Wu J, et al · · 2019 · cited 482× · PMID 31871778 · DOI 10.1038/s41392-019-0099-9
2. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
3. Combined Checkpoint Inhibition and Chemotherapy: New Era of 1^st-Line Treatment for Non-Small-Cell Lung Cancer.
   Wang C, Kulkarni P, Salgia R. · · 2019 · cited 28× · PMID 30976658 · DOI 10.1016/j.omto.2019.02.001
4. MAPK Pathway-Activating Alteration and Immunotherapy Efficacy in Squamous Cell Lung Carcinoma: Results from the Randomized, Prospective SQUINT Trial.
   Cappuzzo F, Ricciuti B, Delmonte A, Bonanno L, et al · · 2025 · cited 3× · PMID 39836372 · DOI 10.1158/1078-0432.ccr-24-2077