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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05089734




Registration number
NCT05089734
Ethics application status
Date submitted
11/10/2021
Date registered
22/10/2021

Titles & IDs
Public title
Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Scientific title
Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
Secondary ID [1] 0 0
2021-003578-30
Secondary ID [2] 0 0
GS-US-577-6153
Universal Trial Number (UTN)
Trial acronym
EVOKE-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sacituzumab Govitecan-hziy (SG)
Treatment: Drugs - Docetaxel

Experimental: Sacituzumab Govitecan-hziy (SG) - 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.

Active comparator: Docetaxel - 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: Other: Sacituzumab Govitecan-hziy (SG)
Administered intravenously

Treatment: Drugs: Docetaxel
Administered intravenously
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS) Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1
Timepoint [3] 0 0
Up to 30 months
Secondary outcome [4] 0 0
Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
First dose date up to 30 months plus 30 days
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Laboratory abnormalities
Timepoint [6] 0 0
First dose date up to 30 months plus 30 days
Secondary outcome [7] 0 0
Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Score
Timepoint [7] 0 0
Up to 30 Months
Secondary outcome [8] 0 0
Time to First Deterioration in NSCLC-SAQ Total Score
Timepoint [8] 0 0
Up to 30 Months

Eligibility
Key inclusion criteria
Key

* 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).
* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.
* Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.

* No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.
* Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.
* Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before randomization.
* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin = 9 g/dL, absolute neutrophil count = 1500/mm^3, and platelets = 100,000/µL).
* Adequate hepatic function (bilirubin = 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase = 2.5 ULN or = 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).
* Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.
* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mixed small-cell lung cancer and NSCLC histology.
* Positive serum pregnancy test or women who are lactating.
* Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.
* Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent.
* Previously received treatment with any of the following:

* Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1
* Trop-2-targeted therapy
* Docetaxel as monotherapy or in combination with other agents
* Active second malignancy
* NSCLC that is eligible for definitive local therapy alone.
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active cardiac disease
* Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
* Active serious infection requiring antibiotics.
* Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
* Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease.
* Positive hepatitis C antibody and detectable hepatitis C viral load.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
Accrual to date
Final
603
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Southern Highlands Cancer Centre - Bowral
Recruitment hospital [3] 0 0
St Vincent's Public Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [5] 0 0
Gallipoli Medical Research Foundation - Greenslopes
Recruitment hospital [6] 0 0
Flinders Medical centre - Bedford Park
Recruitment hospital [7] 0 0
Icon Cancer Centre - Hobart
Recruitment hospital [8] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [9] 0 0
Monash Health - Clayton
Recruitment hospital [10] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [11] 0 0
Joondalup Health Campus - Joondalup
Recruitment hospital [12] 0 0
ir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2576 - Bowral
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
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4575 - Birtinya
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3199 - Frankston
Recruitment postcode(s) [11] 0 0
6027 - Joondalup
Recruitment postcode(s) [12] 0 0
6009 - Perth
Recruitment outside Australia
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United States of America
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Alaska
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Arizona
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Istanbul
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Sariyer
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Yenimahalle
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United Kingdom
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Birmingham
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Colchester
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Glasgow
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Leeds
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Leicester
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London
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05089734