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RecruitingLast updated: 23 April 2024

EVOKE-02: This phase II study is seeking to determine the appropriate dose level, safety and effectiveness of targeted therapy (Sacituzumab Govitecan-hziy) in combination with immunotherapy (pembrolizumab) or in combination with immunotherapy and chemotherapy (pembrolizumab, carboplatin and/or cisplatin) in people with advanced or metastatic non-small cell lung cancerAn 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

Clinical summary

Summary

This study consists of 6 experimental cohorts, 2 of which are safety-run in cohorts.

In the Safety Run in Cohort for Sacituzumab Govitecan-hziy (SG) + pembrolizumab + carboplatin, participants will receive SG (de-escalating dose levels: 10.0mg/kg, 7.5mg/kg, or 5.0mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin area under the concentration versus time curve (AUC)5 on Day 1 of a 21-day cycle.

In the Safety Run in Cohort for SG + pembrolizumab + cisplatin, participants will receive SG (either 10mg/kg or 7.5mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + cisplatin (75mg/m^2) on Day 1 of a 21-day cycle.

In the Experimental Cohort A, participants assigned to Cohort A according to tumour proportion score (TPS) status will receive SG (10mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle.

In the Experimental Cohort B according to TPS status, participants will receive SG (10mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle.

In Experimental Cohort C, participants assigned according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin (75mg/m^2) as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.

In Experimental Cohort D, participants assigned according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin (75mg/m^2) as determined during the safety run-in cohorts on Day 1 of a 21-day cycle. All treatments will be administered intravenously.

Conditions

This trial is treating patients with non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

EVOKE-02

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Gilead Sciences, Inc.

Scientific 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

Eligibility

Inclusion

  • 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

Exclusion

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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