Study of Sacituzumab Govitecan-hziy Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations (EVOKE-02)
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| ClinicalTrials.gov Identifier: NCT05186974 |
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Recruitment Status :
Recruiting
First Posted : January 11, 2022
Last Update Posted : February 21, 2023
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Sponsor:
Gilead Sciences
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
The primary objectives of the study are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of SG in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin) in participants with advanced or metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations.
| 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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 164 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 : | May 2023 |
| Estimated Study Completion Date : | February 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Sacituzumab govitecan
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
Drug: Pembrolizumab Administered intravenously
Other Name: Keytruda® |
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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.
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Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
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.
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Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
Drug: Pembrolizumab Administered intravenously
Other Name: Keytruda® Drug: Carboplatin Administered intravenously
Other Name: Paraplatin® |
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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:
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:
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:
Drug: Pembrolizumab Administered intravenously
Other Name: Keytruda® Drug: Carboplatin Administered intravenously
Other Name: Paraplatin® Drug: Cisplatin Administered intravenously
Other Name: Platinol® |
Primary Outcome Measures :
- 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 ]
- 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 :
- Progression-free Survival as Assessed by IRC per RECIST Version 1.1 [ Time Frame: Up to 24 Months ]
- Overall Survival [ Time Frame: Up to 24 Months ]
- Duration of Response as Assessed by IRC per RECIST Version 1.1 [ Time Frame: Up to 24 Months ]
- Disease Control Rate as Assessed by IRC per RECIST Version 1.1 [ Time Frame: Up to 24 Months ]
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 24 Months plus 30 days ]
- Percentage of Participants Experiencing Clinical Laboratory Abnormalities [ Time Frame: First dose date up to 24 Months plus 30 days ]
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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.
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
Contacts
| Contact: Gilead Clinical Study Information Center | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
Locations
Show 74 study locations
Sponsors and Collaborators
Gilead Sciences
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Additional Information:
| 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 ) |
| First Posted: | January 11, 2022 Key Record Dates |
| Last Update Posted: | February 21, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 Antineoplastic Agents Antineoplastic Agents, Immunological |