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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05186974




Registration number
NCT05186974
Ethics application status
Date submitted
23/12/2021
Date registered
11/01/2022

Titles & IDs
Public title
Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
Scientific title
An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations
Secondary ID [1] 0 0
2021-004280-27
Secondary ID [2] 0 0
GS-US-576-6220
Universal Trial Number (UTN)
Trial acronym
EVOKE-02
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: Drugs - Sacituzumab Govitecan-hziy (SG)
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin

Experimental: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A) - 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.

Experimental: SG + Pembrolizumab (Cohort B) - 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.

Experimental: SG + Pembrolizumab + Carboplatin Safety Run-in - 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.

Experimental: SG + Pembrolizumab + Cisplatin Safety Run-in (Optional) - 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.

Experimental: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) - 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.

Experimental: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) - 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.

Experimental: SG + Pembrolizumab + Cisplatin (Cohort E) - 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: Drugs: Sacituzumab Govitecan-hziy (SG)
Administered intravenously

Treatment: Drugs: Pembrolizumab
Administered intravenously

Treatment: Drugs: Carboplatin
Administered intravenously

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

Outcomes
Primary outcome [1] 0 0
Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [1] 0 0
Up to 22 Months
Primary outcome [2] 0 0
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
Timepoint [2] 0 0
First dose date up to 21 days
Secondary outcome [1] 0 0
Progression-free Survival as Assessed by IRC per RECIST Version 1.1
Timepoint [1] 0 0
Up to 24 Months
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
Up to 24 Months
Secondary outcome [3] 0 0
Duration of Response as Assessed by IRC per RECIST Version 1.1
Timepoint [3] 0 0
Up to 24 Months
Secondary outcome [4] 0 0
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Timepoint [4] 0 0
Up to 24 Months
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
First dose date up to 24 Months plus 30 days
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Timepoint [6] 0 0
First dose date up to 24 Months plus 30 days

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 2
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
30/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Southern Highlands Cancer Centre - Bowral
Recruitment hospital [2] 0 0
Saint Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [4] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [5] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
Ashford Cancer Centre Research - Windsor Gardens
Recruitment hospital [8] 0 0
Peninsula Health - Frankston Hospital - Frankston
Recruitment hospital [9] 0 0
Western Health - Sunshine Hospital - Melbourne
Recruitment hospital [10] 0 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 0 0
2576 - Bowral
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5087 - Windsor Gardens
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3021 - Melbourne
Recruitment postcode(s) [10] 0 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
France
State/province [15] 0 0
Boulogne-Billancourt
Country [16] 0 0
France
State/province [16] 0 0
Brest
Country [17] 0 0
France
State/province [17] 0 0
Caen
Country [18] 0 0
France
State/province [18] 0 0
Clermont-Ferrand
Country [19] 0 0
France
State/province [19] 0 0
Dijon
Country [20] 0 0
France
State/province [20] 0 0
Le Mans
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Pessac
Country [23] 0 0
France
State/province [23] 0 0
Pierre Benite
Country [24] 0 0
France
State/province [24] 0 0
Saint Herblain
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Chemnitz
Country [27] 0 0
Germany
State/province [27] 0 0
Cologne
Country [28] 0 0
Germany
State/province [28] 0 0
Esslingen
Country [29] 0 0
Germany
State/province [29] 0 0
Frankfurt
Country [30] 0 0
Germany
State/province [30] 0 0
Gauting
Country [31] 0 0
Germany
State/province [31] 0 0
Grosshansdorf
Country [32] 0 0
Germany
State/province [32] 0 0
Halle
Country [33] 0 0
Germany
State/province [33] 0 0
Immenhausen
Country [34] 0 0
Hong Kong
State/province [34] 0 0
Hong Kong
Country [35] 0 0
Hong Kong
State/province [35] 0 0
Kowloon
Country [36] 0 0
Italy
State/province [36] 0 0
Brescia
Country [37] 0 0
Italy
State/province [37] 0 0
Catania
Country [38] 0 0
Italy
State/province [38] 0 0
Parma
Country [39] 0 0
Italy
State/province [39] 0 0
Rome
Country [40] 0 0
Italy
State/province [40] 0 0
Rozzano
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Cheongju-si
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Inchon
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Suwon
Country [45] 0 0
Malaysia
State/province [45] 0 0
Johor Bahru
Country [46] 0 0
Malaysia
State/province [46] 0 0
Kota Bharu
Country [47] 0 0
Malaysia
State/province [47] 0 0
Kuala Lumpur
Country [48] 0 0
Malaysia
State/province [48] 0 0
Kuantan
Country [49] 0 0
Malaysia
State/province [49] 0 0
Kuching
Country [50] 0 0
Malaysia
State/province [50] 0 0
Putrajaya
Country [51] 0 0
Spain
State/province [51] 0 0
A coruna
Country [52] 0 0
Spain
State/province [52] 0 0
Badalona
Country [53] 0 0
Spain
State/province [53] 0 0
Barcelona
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
Spain
State/province [55] 0 0
Majadahonda
Country [56] 0 0
Spain
State/province [56] 0 0
Pamplona
Country [57] 0 0
Spain
State/province [57] 0 0
Rincon de la Victoria
Country [58] 0 0
Spain
State/province [58] 0 0
Santiago de Compostela
Country [59] 0 0
Spain
State/province [59] 0 0
Sevilla
Country [60] 0 0
Spain
State/province [60] 0 0
Valencia
Country [61] 0 0
Taiwan
State/province [61] 0 0
Changhua City
Country [62] 0 0
Taiwan
State/province [62] 0 0
Kaohsiung City
Country [63] 0 0
Taiwan
State/province [63] 0 0
Kaohsiung
Country [64] 0 0
Taiwan
State/province [64] 0 0
Liouying Dist.
Country [65] 0 0
Taiwan
State/province [65] 0 0
Tainan City
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taipei City
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taipei
Country [68] 0 0
Taiwan
State/province [68] 0 0
Taoyuan City
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Birmingham
Country [70] 0 0
United Kingdom
State/province [70] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

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/NCT05186974