Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
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
Date last updated
21/10/2024

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
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).
Trial website
https://clinicaltrials.gov/study/NCT05186974
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05186974