Clinical trial · Interventional
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
NCT02409368CI-TRIAL-00062172Checkmate 171completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort A: Treatment - Nivolumab
- description
- Nivolumab IV infusion
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
- timeFrame
- From first dose to time of analysis of primary endpoint (approximately up to 34 months)
- description
- The total number of participants with high grade treatment related select adverse events.
Secondary outcomes (5)
- measure
- Number of Participants With High Grade Select Adverse Events
- timeFrame
- From first dose up to 100 days post last dose (up to 76 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * ECOG Status: PS 0-1 \& PS 2 * Subjects with histologically or cytologically-documented SqNSCLC * Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen * Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria * Subjects with treated or asymptomatic CNS metastases * Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration * Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab * Males and Females, ages 18 or older Exclusion Criteria: * Subjects with untreated, symptomatic CNS metastases * Subjects with carcinomatous meningitis * Subjects with active, known or suspected autoimmune disease. * Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
References
Publications (1)
- DERIVEDFelip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S. CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations. Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3. PMID 32028209