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Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) (EVOKE-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05186974
Recruitment Status : Active, not recruiting
First Posted : January 11, 2022
Last Update Posted : April 1, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Sacituzumab Govitecan-hziy (SG) Drug: Pembrolizumab Drug: Carboplatin Drug: Cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 30, 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
Participants assigned to Cohorts A according to tumor proportion score (TPS) status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
 Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®
Experimental: SG + Pembrolizumab (Cohort B)
Participants assigned to Cohorts B according to TPS status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
 Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®
Experimental: SG + Pembrolizumab + Carboplatin Safety Run-in
Participants will receive SG (de-escalating dose levels: 10.0 mg/kg, 7.5 mg/kg, or 5.0 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg 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.
 Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®

Drug: Carboplatin
Administered intravenously
Other Name: Paraplatin®
Experimental: SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)
Participants will receive SG (either 10 mg/kg or 7.5 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/m^2 on Day 1 of a 21-day cycle.
 Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®

Drug: Cisplatin
Administered intravenously
Other Name: Platinol®
Experimental: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)
Participants assigned to Cohort C 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 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
 Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®

Drug: Carboplatin
Administered intravenously
Other Name: Paraplatin®

Drug: Cisplatin
Administered intravenously
Other Name: Platinol®
Experimental: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)
Participants assigned to Cohort D 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 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
 Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®

Drug: Carboplatin
Administered intravenously
Other Name: Paraplatin®

Drug: Cisplatin
Administered intravenously
Other Name: Platinol®
Experimental: SG + Pembrolizumab + Cisplatin (Cohort E)
Participants assigned to Cohort E will receive SG RP2D, as determined following safety review of Cohorts C and D, on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/ m^2 on Day 1 of a 21-day cycle.
 Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®

Drug: Cisplatin
Administered intravenously
Other Name: Platinol®


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05186974


Locations
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Sponsors and Collaborators
Gilead Sciences
Merck Sharp & Dohme LLC
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05186974    
Other Study ID Numbers: GS-US-576-6220
2021-004280-27 ( EudraCT Number )
KEYNOTE-D15 ( Other Identifier: Merck Sharp & Dohme LLC )
MK-3475-D15 ( Other Identifier: Merck & Co., Inc. )
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: April 1, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Carboplatin
Pembrolizumab
Sacituzumab govitecan
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs