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NCT Number: NCT05186974

Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern Highlands Cancer Centre, Bowral, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator
  • No prior systemic treatment for metastatic NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate hematologic counts
  • Adequate hepatic function

Key Exclusion Criteria:

  • Mixed SCLC and NSCLC histology
  • Active second malignancy
  • NSCLC that is eligible for definitive local therapy alone
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has had an allogenic tissue/solid organ transplant.
  • Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient
  • Has received radiation therapy to the lung
  • Individuals may not have received systemic anticancer treatment within the previous 6 months
  • Is currently participating in or has participated in a study of an investigational agent
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Known active central nervous system (CNS) metastases
  • History of cardiac disease
  • Active chronic inflammatory bowel disease
  • Active serious infection requiring antibiotics
  • Active or chronic hepatitis B infection
  • Positive hepatitis C antibody
  • Positive serum pregnancy test or women who are lactating

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Sacituzumab Govitecan-hziy (SG)

Drug

Administered intravenously

Other names: GS-0132, IMMU-132

Pembrolizumab

Drug

Administered intravenously

Other names: KEYTRUDA®

carboplatin

Drug

Administered intravenously

Other names: Paraplatin®

Cisplatin

Drug

Administered intravenously

Other names: Platinol®

Primary outcomes

  1. Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Time frame: Up to 22 Months

  2. Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts

    Time frame: First dose date up to 21 days

Secondary outcomes

  1. Progression-free Survival as Assessed by IRC per RECIST Version 1.1

    Time frame: Up to 24 Months

  2. Overall Survival

    Time frame: Up to 24 Months

  3. Duration of Response as Assessed by IRC per RECIST Version 1.1

    Time frame: Up to 24 Months

  4. Disease Control Rate as Assessed by IRC per RECIST Version 1.1

    Time frame: Up to 24 Months

  5. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: First dose date up to 24 Months plus 30 days

  6. Percentage of Participants Experiencing Clinical Laboratory Abnormalities

    Time frame: First dose date up to 24 Months plus 30 days

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

Acronym: EVOKE-02

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2022
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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