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Anti-microtubule agent
Sacituzumab Govitecan for Lung Cancer (EVOKE-01 Trial)
Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition)
Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
EVOKE-01 Trial Summary
This trial will compare overall survival of two treatments for lung cancer patients who have progressed after other treatments.
Who is the study for?
This trial is for adults with advanced or metastatic NSCLC who have already tried a platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. They must have proper liver function, no active second cancers, no brain metastases, and not be pregnant or breastfeeding. Participants need to have recovered from previous treatments' side effects and can't join if they've had certain other cancer therapies.Check my eligibility
What is being tested?
The study compares Sacituzumab Govitecan (SG) with Docetaxel in treating NSCLC. Patients will be randomly assigned to receive either SG or Docetaxel to determine which is more effective at controlling the disease.See study design
What are the potential side effects?
Sacituzumab Govitecan may cause nausea, diarrhea, hair loss, fatigue, neutropenia (low white blood cell count), and anemia. Docetaxel can lead to similar side effects including fluid retention and allergic reactions.
EVOKE-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be at stage 4.
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My kidneys work well enough to clear at least 30 mL/min of creatinine.
Select...
My cancer got worse after treatment with platinum chemotherapy and anti-PD-1/PD-L1 drugs.
Select...
My blood counts are within the required range without needing transfusions or growth support.
Select...
I have received a TKI treatment for my cancer due to a specific genetic change.
Select...
My liver is functioning well according to recent tests.
Select...
My lung cancer has worsened despite recent treatment.
Select...
I haven't received treatments for recurrent/metastatic cancer due to lack of specific genomic changes.
Select...
My cancer can be measured on a scan.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
EVOKE-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1
Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1
Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1
+5 moreSide effects data
From 2020 Phase 1 & 2 trial • 515 Patients • NCT0163155269%
Nausea
61%
Diarrhoea
57%
Fatigue
44%
Vomiting
44%
Alopecia
42%
Anaemia
40%
Neutropenia
37%
Constipation
35%
Decreased appetite
22%
Abdominal pain
20%
Neutrophil count decreased
20%
Cough
20%
Dyspnoea
18%
Hypokalaemia
18%
Hypomagnesaemia
16%
Dehydration
16%
Headache
16%
Pyrexia
16%
White blood cell count decreased
16%
Dizziness
16%
Rash
16%
Oedema peripheral
15%
Weight decreased
15%
Back pain
14%
Arthralgia
13%
Urinary tract infection
13%
Hypophosphataemia
13%
Pruritus
12%
Upper respiratory tract infection
12%
Insomnia
11%
Hyperglycaemia
11%
Blood alkaline phosphatase increased
9%
Pain in extremity
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
8%
Lymphocyte count decreased
8%
Hyponatraemia
8%
Rhinorrhoea
8%
Dry skin
7%
Dysgeusia
7%
Chest pain
7%
Chills
7%
Activated partial thromboplastin time prolonged
6%
Depression
6%
Hypoalbuminaemia
6%
Neuropathy peripheral
6%
Anxiety
6%
Muscular weakness
6%
Myalgia
6%
Epistaxis
6%
Nasal congestion
5%
Dyspepsia
5%
Gastrooesophageal reflux disease
5%
Asthenia
5%
Pain
5%
Hypocalcaemia
5%
Hypotension
5%
Abdominal distension
5%
Stomatitis
5%
Haematuria
4%
Febrile neutropenia
3%
Pneumonia
1%
Mental status changes
1%
Small intestinal obstruction
1%
Sepsis
1%
Syncope
1%
Atrial fibrillation
1%
Colitis
1%
Hypoxia
1%
Pleural effusion
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Safety Population
EVOKE-01 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab Govitecan-hziy (SG)Experimental Treatment1 Intervention
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Group II: DocetaxelActive Control1 Intervention
Participants will receive docetaxel 75 mg/m^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy (SG)
2012
Completed Phase 2
~520
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,238 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,232 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment or still have side effects from the last one.I still have significant side effects from a previous treatment.I have been treated with specific cancer drugs like Topoisomerase 1 inhibitors, Trop-2 therapy, or Docetaxel.I agree to use birth control as specified by the study.I have a current heart condition.I am HIV positive with a detectable viral load or take medication that affects SN-38 metabolism.I have an ongoing inflammatory bowel condition or had a GI perforation in the last 6 months.My lung cancer is confirmed to be at stage 4.I have hepatitis C with a detectable viral load.I have severe lung problems or diseases affecting my lungs.My kidneys work well enough to clear at least 30 mL/min of creatinine.My cancer got worse after treatment with platinum chemotherapy and anti-PD-1/PD-L1 drugs.My blood counts are within the required range without needing transfusions or growth support.I have received a TKI treatment for my cancer due to a specific genetic change.I have another type of cancer that is currently active.My liver is functioning well according to recent tests.My lung cancer has worsened despite recent treatment.I have active brain metastases or cancer in the lining of my brain.My NSCLC can be treated with local therapy only.My lung cancer is a mix of small-cell and non-small cell types.I tested positive for hepatitis B.I haven't received treatments for recurrent/metastatic cancer due to lack of specific genomic changes.My cancer can be measured on a scan.I am fully active or restricted in physically strenuous activity but can do light work.I am currently taking antibiotics for a serious infection.My cancer has been tested for EGFR, ALK, and PD-1/PD-L1 markers.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan-hziy (SG)
- Group 2: Docetaxel
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Are there any unfilled appointments for this research project?
"The study, which was first announced on November 17th, 2021 is looking for participants and still open to enrolment according to the latest update from clinicaltrials.gov on November 7th, 2022."
Answered by AI
Is this study taking place at several hospitals across Canada?
"At present, this study is enrolling patients at 44 sites across the country. Locations include Chicago, Milwaukee, Charlotte and many others. If you are interested in enrolling, it may be helpful to select a clinic that is located close to you in order to minimize travel requirements."
Answered by AI
Could you list any other investigations that have used SG?
"Currently, there are 367 active clinical trials studying Sacituzumab Govitecan-hziy (SG), with the majority of these being Phase 3 trials. The largest city for research is Fuzhou in Fujian Province, however there are a total of 24022 locations conducting these SG trials."
Answered by AI
How many people are part of this research project?
"The sponsor, Gilead Sciences, needs to recruit 520 eligible patients from multiple clinical trial sites including University of Chicago Medical Center and Froedtert Hospital/Medical College of Wisconsin."
Answered by AI
Are there any short or long term dangers to patients that have been seen with SG use?
"There is both some efficacy data and multiple rounds of safety data from earlier trials, so our team rates the safety of Sacituzumab Govitecan-hziy (SG) as a 3."
Answered by AI
What are the conditions that commonly warrant treatment with Sacituzumab Govitecan-hziy (SG)?
"SG is commonly used to treat patients with malignant neoplasms, but it can also help those suffering from sarcoma and uc 84572."
Answered by AI
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