Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date last updated
23/05/2025
Titles & IDs
Public title
Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Query!
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
Query!
Secondary ID [1]
0
0
jRCT2051220119
Query!
Secondary ID [2]
0
0
GS-US-577-6153
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EVOKE-01
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.
Query!
Timepoint [1]
0
0
Up to 24.4 months
Query!
Secondary outcome [1]
0
0
Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Query!
Assessment method [1]
0
0
PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first as assessed by RECIST v.1.1. As per RECIST 1.1, PD was defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Participants who did not have documented disease progression and did not die were censored at their last tumor assessment date. Kaplan-Meier estimate was used for analysis.
Query!
Timepoint [1]
0
0
Up to 24.4 months
Query!
Secondary outcome [2]
0
0
Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1
Query!
Assessment method [2]
0
0
ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) that was confirmed at least 4 weeks later as assessed by RECIST v.1.1. As per RECIST 1.1 CR was defined as: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was defined as: At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Query!
Timepoint [2]
0
0
Up to 24.4 months
Query!
Secondary outcome [3]
0
0
Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1
Query!
Assessment method [3]
0
0
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by RECIST v. 1.1. As per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, and PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Kaplan-Meier estimate was used for analysis.
Query!
Timepoint [3]
0
0
Up to 24.4 months
Query!
Secondary outcome [4]
0
0
Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1
Query!
Assessment method [4]
0
0
DCR was defined as the percentage of participants who achieved a CR, PR,or stable disease(SD)as assessed by RECIST v.1.1. Per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum LD since the treatment started and persistence of 1 or more nontarget lesion(s).PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study),in addition of increase of 20% sum also demonstrate an absolute increase of at least 5 mm or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.
Query!
Timepoint [4]
0
0
Up to 24.4 months
Query!
Secondary outcome [5]
0
0
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
Query!
Assessment method [5]
0
0
An AE was defined as any untoward medical occurrence in a participants administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0.
Query!
Timepoint [5]
0
0
Up to 3.5 years
Query!
Secondary outcome [6]
0
0
Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline
Query!
Assessment method [6]
0
0
Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 will be reported.
Query!
Timepoint [6]
0
0
Up to 3.5 years
Query!
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)
Query!
Assessment method [7]
0
0
The NSCLC-SAQ is a participant reported outcome with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \
At All" to "Very severe \
" or from "Never to Always" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4, with total score ranging from 0 to 20. The dyspnea (shortness of breath) item uses a "Never(0) to Always(4)" rating scale with higher score indicating higher frequency of dyspnea. Time to deterioration (TTD) was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For shortness of breath domain, a 1-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.
Query!
Timepoint [7]
0
0
Up to 24.4 months
Query!
Secondary outcome [8]
0
0
Time to First Deterioration in NSCLC-SAQ Total Score
Query!
Assessment method [8]
0
0
The NSCLC-SAQ is a participant reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \
At All" to "Very severe \
" or from "Never to Always" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4. A total score sums all five domain scores at each visit. If any domain score was missing, the score was not computed. The total score ranges between 0 and 20, with higher scores indicating more severe symptoms. TTD was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For NSCLC-SAQ total score, a 2-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.
Query!
Timepoint [8]
0
0
Up to 24.4 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/11/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/01/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
603
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
Border Medical Oncology Research Unit - Albury
Query!
Recruitment hospital [2]
0
0
Southern Highlands Cancer Centre - Bowral
Query!
Recruitment hospital [3]
0
0
St Vincent's Public Hospital - Darlinghurst
Query!
Recruitment hospital [4]
0
0
Sunshine Coast University Private Hospital - Birtinya
Query!
Recruitment hospital [5]
0
0
Gallipoli Medical Research Foundation - Greenslopes
Query!
Recruitment hospital [6]
0
0
Flinders Medical centre - Bedford Park
Query!
Recruitment hospital [7]
0
0
Icon Cancer Centre - Hobart
Query!
Recruitment hospital [8]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [9]
0
0
Monash Health - Clayton
Query!
Recruitment hospital [10]
0
0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Query!
Recruitment hospital [11]
0
0
Joondalup Health Campus - Joondalup
Query!
Recruitment hospital [12]
0
0
ir Charles Gairdner Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
2640 - Albury
Query!
Recruitment postcode(s) [2]
0
0
2576 - Bowral
Query!
Recruitment postcode(s) [3]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [4]
0
0
4575 - Birtinya
Query!
Recruitment postcode(s) [5]
0
0
4120 - Greenslopes
Query!
Recruitment postcode(s) [6]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [7]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [8]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [9]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [10]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [11]
0
0
6027 - Joondalup
Query!
Recruitment postcode(s) [12]
0
0
6009 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alaska
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Iowa
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nevada
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Tennessee
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Texas
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Virginia
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Wisconsin
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Innsbruck
Query!
Country [23]
0
0
Austria
Query!
State/province [23]
0
0
Salzburg
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Vienna
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Brasschaat
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Brussels
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Edegem
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Gent
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Mons
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Fortaleza
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Ijui
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Itajai
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Jau
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Porto Alegre
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Sao Paolo
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Sao Paulo
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
São Paulo
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Barrie
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Brampton
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Montreal
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Rimouski
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Windsor
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Avignon
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Bayonne
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Boulogne-Billancourt
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Caen
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Calvados
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Chauny
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Clermont Ferrand
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Creteil
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Epagny Metz-tessy
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
La Roche-sur-Yon
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Le Mans
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Lille
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Limoges cedex
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Montpellier
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Mulhouse
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Paris cedex 05
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Pessac
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Pierre Benite
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Poitiers
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Rouen
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
saint Herblain
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Saint Herblain
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Strasbourg
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Toulon cedex
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Braunschweig
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Esslingen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Hamburg
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Heilbronn
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Immenhausen
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Kassel
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Lubeck
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Mannheim
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Munchen-Gauting
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Offenbach
Query!
Country [77]
0
0
Greece
Query!
State/province [77]
0
0
Athens
Query!
Country [78]
0
0
Greece
Query!
State/province [78]
0
0
Cholargos
Query!
Country [79]
0
0
Greece
Query!
State/province [79]
0
0
Heraklion
Query!
Country [80]
0
0
Greece
Query!
State/province [80]
0
0
Larisa
Query!
Country [81]
0
0
Greece
Query!
State/province [81]
0
0
Nea Kifisia
Query!
Country [82]
0
0
Greece
Query!
State/province [82]
0
0
Thessaloniki
Query!
Country [83]
0
0
Israel
Query!
State/province [83]
0
0
Ashdod
Query!
Country [84]
0
0
Israel
Query!
State/province [84]
0
0
Beer Seva
Query!
Country [85]
0
0
Israel
Query!
State/province [85]
0
0
Jerusalem
Query!
Country [86]
0
0
Israel
Query!
State/province [86]
0
0
Rehovot
Query!
Country [87]
0
0
Israel
Query!
State/province [87]
0
0
Tel Aviv
Query!
Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Tzrifin
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Bergamo
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Brescia
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Catania
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Catanzaro
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Cremona
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Milano
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Pavia
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Roma
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
San Giovanni Rotondo
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Treviglio
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Varese
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Asahikawa
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Chuo
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Fukui
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Hirakata
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Hiroshima
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Hyogo
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Inzai
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Iwakuni
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Kagoshima
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Kanagawaken
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Kanazawa
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Kashiwa
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Kitaadachi-gun
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Koto
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Kurume
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Kyoto
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Matsuyama
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Miyagi
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Nagasaki
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Nagoya
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Niigata
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Okayama
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Osakasayama-Shi
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Osaka
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Sakai
Query!
Country [125]
0
0
Japan
Query!
State/province [125]
0
0
Shinjuku-Ku
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Sunto-gun
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Toyonaka
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Utsunomiya
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Wakayama
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Yokohama
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Yonago
Query!
Country [132]
0
0
Mexico
Query!
State/province [132]
0
0
Ciudad de Mexico
Query!
Country [133]
0
0
Mexico
Query!
State/province [133]
0
0
Guadalajara
Query!
Country [134]
0
0
Netherlands
Query!
State/province [134]
0
0
Breda
Query!
Country [135]
0
0
Netherlands
Query!
State/province [135]
0
0
Den Haag
Query!
Country [136]
0
0
Netherlands
Query!
State/province [136]
0
0
Maastricht
Query!
Country [137]
0
0
Netherlands
Query!
State/province [137]
0
0
Rotterrdam
Query!
Country [138]
0
0
Netherlands
Query!
State/province [138]
0
0
Tilburg
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Konin
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Lodz
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Rzeszáw
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Siedlce
Query!
Country [143]
0
0
Portugal
Query!
State/province [143]
0
0
Coimbra
Query!
Country [144]
0
0
Portugal
Query!
State/province [144]
0
0
Lisboa
Query!
Country [145]
0
0
Portugal
Query!
State/province [145]
0
0
Lisbon
Query!
Country [146]
0
0
Portugal
Query!
State/province [146]
0
0
Matosinhos
Query!
Country [147]
0
0
Portugal
Query!
State/province [147]
0
0
Porto
Query!
Country [148]
0
0
Puerto Rico
Query!
State/province [148]
0
0
Ponce
Query!
Country [149]
0
0
Puerto Rico
Query!
State/province [149]
0
0
San Juan
Query!
Country [150]
0
0
Spain
Query!
State/province [150]
0
0
A coruna
Query!
Country [151]
0
0
Spain
Query!
State/province [151]
0
0
Badalona
Query!
Country [152]
0
0
Spain
Query!
State/province [152]
0
0
Barakaldo
Query!
Country [153]
0
0
Spain
Query!
State/province [153]
0
0
Barcelona
Query!
Country [154]
0
0
Spain
Query!
State/province [154]
0
0
Cáceres
Query!
Country [155]
0
0
Spain
Query!
State/province [155]
0
0
Girona
Query!
Country [156]
0
0
Spain
Query!
State/province [156]
0
0
Madrid
Query!
Country [157]
0
0
Spain
Query!
State/province [157]
0
0
Malaga
Query!
Country [158]
0
0
Spain
Query!
State/province [158]
0
0
Murcia
Query!
Country [159]
0
0
Spain
Query!
State/province [159]
0
0
Pamplona
Query!
Country [160]
0
0
Spain
Query!
State/province [160]
0
0
Sabadell
Query!
Country [161]
0
0
Spain
Query!
State/province [161]
0
0
Sevilla
Query!
Country [162]
0
0
Spain
Query!
State/province [162]
0
0
Valencia
Query!
Country [163]
0
0
Turkey
Query!
State/province [163]
0
0
Ankara
Query!
Country [164]
0
0
Turkey
Query!
State/province [164]
0
0
Bursa
Query!
Country [165]
0
0
Turkey
Query!
State/province [165]
0
0
Dikimevi- Ankara
Query!
Country [166]
0
0
Turkey
Query!
State/province [166]
0
0
Edirne
Query!
Country [167]
0
0
Turkey
Query!
State/province [167]
0
0
Istanbul
Query!
Country [168]
0
0
Turkey
Query!
State/province [168]
0
0
Kadikoy
Query!
Country [169]
0
0
Turkey
Query!
State/province [169]
0
0
Sariyer
Query!
Country [170]
0
0
Turkey
Query!
State/province [170]
0
0
Yenimahalle
Query!
Country [171]
0
0
United Kingdom
Query!
State/province [171]
0
0
Birmingham
Query!
Country [172]
0
0
United Kingdom
Query!
State/province [172]
0
0
Colchester
Query!
Country [173]
0
0
United Kingdom
Query!
State/province [173]
0
0
Glasgow
Query!
Country [174]
0
0
United Kingdom
Query!
State/province [174]
0
0
Leeds
Query!
Country [175]
0
0
United Kingdom
Query!
State/province [175]
0
0
Leicester
Query!
Country [176]
0
0
United Kingdom
Query!
State/province [176]
0
0
London
Query!
Country [177]
0
0
United Kingdom
Query!
State/province [177]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).
Query!
Trial website
https://clinicaltrials.gov/study/NCT05089734
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/34/NCT05089734/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/34/NCT05089734/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05089734
Download to PDF