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TerminatedPhase 3NCT03626545
Official study title

Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

Study summary

This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCanakinumab and Docetaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 21, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?78 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: Canakinumab; Drug: Docetaxel; Other: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.
  • Subject had received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
  • Subject with ECOG performance status (PS) of 0 or 1.
  • Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria. Key
Reasons someone may not be able to joinExclusion criteria
  • Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
  • Subject with EGFRor ALK positive tumor.
  • History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Emory Winship Cancer InstituteAtlanta, Georgia
  • Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of RegulatoryKansas City, Missouri
  • Montefiore Medical Center Albert Einstein College of MedThe Bronx, New York
  • University of Cincinnati Cancer InstituteCincinnati, Ohio
  • MD AndersonHouston, Texas
  • Huntsman Cancer Institute Univ of Utah .Salt Lake City, Utah
  • Novartis Investigative SiteBerazategui, Buenos Aires
  • Novartis Investigative SiteCABA, Buenos Aires
  • Novartis Investigative SiteMar del Plata, Buenos Aires
  • Novartis Investigative SiteLa Rioja
  • Novartis Investigative SiteSantiago del Estero
  • Novartis Investigative SiteGreenslopes, Queensland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2023. Always confirm current availability with the study team.

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