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Alkylating agents
Sacituzumab Govitecan Combo for Lung Cancer (EVOKE-02 Trial)
Phase 2
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
EVOKE-02 Trial Summary
This trial is testing a new combination therapy for advanced or metastatic non-small-cell lung cancer (NSCLC) that has not responded to other treatments. The primary objectives are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of the new therapy.
Who is the study for?
This trial is for adults with advanced or metastatic non-small-cell lung cancer (NSCLC) who haven't had systemic treatment for it. They should have a good performance status, meaning they can carry out daily activities with little or no assistance. Their blood counts and liver function need to be within certain ranges, and their disease must be measurable on scans.Check my eligibility
What is being tested?
Researchers are testing the drug sacituzumab govitecan-hziy (SG), alone and in combination with pembrolizumab and either carboplatin or cisplatin. The study aims to find effective dosing regimens for patients with NSCLC that has spread beyond its original site.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, lowered blood cell counts which can increase infection risk, potential liver issues, fatigue, nausea, and other symptoms related to how these drugs affect the body's normal cells as well as cancer cells.
EVOKE-02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at stage IV.
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My cancer can be measured on scans and I haven't had systemic treatment for advanced lung cancer.
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I am fully active or can carry out light work.
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My lung cancer is at stage IV.
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My cancer can be measured on scans according to specific criteria.
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I haven't had any systemic treatment for my advanced lung cancer.
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I am fully active or can carry out light work.
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My lung cancer is at stage IV.
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My cancer can be measured on scans.
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I haven't had any systemic treatment for my advanced lung cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
EVOKE-02 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
Secondary outcome measures
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Duration of Response as Assessed by IRC per RECIST Version 1.1
Overall Survival
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
EVOKE-02 Trial Design
7Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)Experimental Treatment2 Interventions
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.
Group II: SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)Experimental Treatment3 Interventions
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.
Group III: SG + Pembrolizumab + Cisplatin (Cohort E)Experimental Treatment3 Interventions
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.
Group IV: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)Experimental Treatment4 Interventions
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.
Group V: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)Experimental Treatment4 Interventions
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.
Group VI: SG + Pembrolizumab + Carboplatin Safety Run-inExperimental Treatment3 Interventions
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.
Group VII: SG + Pembrolizumab (Cohort B)Experimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy (SG)
2012
Completed Phase 2
~520
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,255 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,060,041 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,469 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured on scans.My cancer can be measured on scans according to specific criteria.I haven't had any systemic treatment for my advanced lung cancer.My blood cell counts are within a healthy range.I have an immune system disorder or am on long-term steroids.I have been treated for an autoimmune disease in the last 2 years.I haven't had any cancer treatment in the last 6 months.I have an ongoing or chronic hepatitis B infection.I haven't had any systemic treatment for my advanced lung cancer.I am fully active or restricted in physically strenuous activity but can do light work.I have received an organ or tissue transplant from another person.I have a history of heart disease.I have severe lung problems due to other lung diseases.My lung cancer is at stage IV.My liver is working well.My liver is working well.My lung cancer is at stage IV.My blood cell counts are within a healthy range.My lung cancer is at stage IV.My lung cancer is a mix of small cell and non-small cell types.I have another type of cancer that is currently active.My NSCLC can be treated with local therapy only.I have a severe allergy to SG, pembrolizumab, carboplatin, or cisplatin.I have active cancer spread to my brain or spinal cord.I am fully active or can carry out light work.My blood cell counts are within a healthy range.I am fully active or can carry out light work.I have undergone radiation therapy for my lung.I have an ongoing inflammatory bowel condition.I am currently taking antibiotics for a serious infection.I'm sorry, I cannot summarize or rewrite the criterion without additional context. Please provide more information.My liver is working well.My cancer can be measured on scans and I haven't had systemic treatment for advanced lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: SG + Pembrolizumab + Carboplatin Safety Run-in
- Group 2: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)
- Group 3: SG + Pembrolizumab + Cisplatin (Cohort E)
- Group 4: SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)
- Group 5: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)
- Group 6: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
- Group 7: SG + Pembrolizumab (Cohort B)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pembrolizumab been officially sanctioned by the Food and Drug Administration?
"Pembrolizumab's safety is rated 2, as it has only undergone clinical testing to ascertain its security but not yet efficacy."
Answered by AI
How many physical sites are offering this research opportunity?
"This ground-breaking research is conducted across 15 sites in total, the three major centres being Stanford Cancer Institute (Stanford, Illinois), UC Irvine Medical Center (Orange, North carolina) and Orchard Healthcare Research Inc. (Skokie, Georgia)."
Answered by AI
What is the upper limit for patients participating in this trial?
"164 eligible patients are required to join this trial, with enrolment occurring at Stanford Cancer Institute (Stanford, Illinois) and UC Irvine Medical Center (Orange County, North carolina)."
Answered by AI
Are there still opportunities for participants in this experiment?
"This trial is currently open to potential participants. Clinicaltrials.gov indicates that it was first announced on May 30th 2022 and last revised on November 16th 2022."
Answered by AI
Who else is applying?
What site did they apply to?
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
What portion of applicants met pre-screening criteria?
Met criteria
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