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

Gilead Sciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Sacituzumab Govitecan-hziy (SG); Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05186974

KEYNOTE-D15 (Other Identifier)

2021-004280-27 (EudraCT Number)

GS-US-576-6220

MK-3475-D15 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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193 participants in 7 patient groups

Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)

Experimental group

Description:

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.

Treatment:

Drug: Pembrolizumab

Drug: Sacituzumab Govitecan-hziy (SG)

SG + Pembrolizumab (Cohort B)

Experimental group

Description:

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.

Treatment:

Drug: Pembrolizumab

Drug: Sacituzumab Govitecan-hziy (SG)

SG + Pembrolizumab + Carboplatin Safety Run-in

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Pembrolizumab

Drug: Sacituzumab Govitecan-hziy (SG)

SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Pembrolizumab

Drug: Sacituzumab Govitecan-hziy (SG)

SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Pembrolizumab

Drug: Sacituzumab Govitecan-hziy (SG)

SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Pembrolizumab

Drug: Sacituzumab Govitecan-hziy (SG)

SG + Pembrolizumab + Cisplatin (Cohort E)

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Pembrolizumab

Drug: Sacituzumab Govitecan-hziy (SG)