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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05676931




Registration number
NCT05676931
Ethics application status
Date submitted
9/12/2022
Date registered
9/01/2023

Titles & IDs
Public title
Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer
Scientific title
A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2022-502916-35-00
Secondary ID [2] 0 0
EDGE-Lung
Universal Trial Number (UTN)
Trial acronym
EDGE-Lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced 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 - Domvanalimab
Treatment: Drugs - Quemliclustat
Treatment: Drugs - Zimberelimab
Treatment: Drugs - Docetaxel
Treatment: Drugs - Platinum-Based Doublet

Experimental: A1: Domvanalimab + Zimberelimab - Domvanalimab and Zimberelimab, both administered by IV infusion

Experimental: A2: Domvanalimab + Zimberelimab - Domvanalimab and Zimberelimab, both administered by IV infusion

Experimental: A3: Quemliclustat + Zimberelimab - Quemliclustat and Zimberelimab, both administered by IV infusion

Experimental: B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy - Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Experimental: B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy - Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Experimental: B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy - Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Experimental: C1: Quemliclustat + Zimberelimab + Docetaxel - Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion

Experimental: C2: Domvanalimab + Zimberelimab + Docetaxel - Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion


Treatment: Drugs: Domvanalimab
Administered as specified in the treatment arm

Treatment: Drugs: Quemliclustat
Administered as specified in the treatment arm

Treatment: Drugs: Zimberelimab
Administered as specified in the treatment arm

Treatment: Drugs: Docetaxel
Administered as specified in the treatment arm

Treatment: Drugs: Platinum-Based Doublet
Administered as specified in the treatment arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Timepoint [1] 0 0
Up to 58 months
Primary outcome [2] 0 0
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 58 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From date of first dose until the date of death due to any cause (approximately 58 months)
Secondary outcome [2] 0 0
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Timepoint [2] 0 0
Up to 58 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Up to 58 months
Secondary outcome [4] 0 0
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Timepoint [4] 0 0
Up to 58 months
Secondary outcome [5] 0 0
Investigational study treatments peak plasma or serum concentration (Cmax)
Timepoint [5] 0 0
Up to 58 months
Secondary outcome [6] 0 0
Investigational study treatments time of peak concentration (Tmax)
Timepoint [6] 0 0
Up to 58 months
Secondary outcome [7] 0 0
Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)
Timepoint [7] 0 0
Up to 58 months
Secondary outcome [8] 0 0
Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants
Timepoint [8] 0 0
Up to 58 months

Eligibility
Key inclusion criteria
* Histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
* At least one measurable target lesion per RECIST v1.1.
* Adequate organ and marrow function
* Participants must be willing to provide adequate tumor tissue
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous
* Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
* Concurrent chronic medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded).
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy

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
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
The Border Cancer Hospital - Albury
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [3] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [4] 0 0
Cancer Research SA Pty Ltd - Adelaide
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Albury
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Strasboug
Country [14] 0 0
France
State/province [14] 0 0
Suresnes
Country [15] 0 0
Georgia
State/province [15] 0 0
Batumi
Country [16] 0 0
Georgia
State/province [16] 0 0
Tbilisi
Country [17] 0 0
Italy
State/province [17] 0 0
Meldola
Country [18] 0 0
Italy
State/province [18] 0 0
Pesaro
Country [19] 0 0
Italy
State/province [19] 0 0
Rome
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Changwon-Si
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Cheongju
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Hwasun-gun
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Poland
State/province [24] 0 0
Poznan
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
Las Palmas De Gran Canaria
Country [27] 0 0
Spain
State/province [27] 0 0
Lugo
Country [28] 0 0
Spain
State/province [28] 0 0
Malaga
Country [29] 0 0
Spain
State/province [29] 0 0
Sevilla
Country [30] 0 0
Spain
State/province [30] 0 0
Valencia
Country [31] 0 0
Taiwan
State/province [31] 0 0
Hualien
Country [32] 0 0
Taiwan
State/province [32] 0 0
Kaoshiung
Country [33] 0 0
Taiwan
State/province [33] 0 0
New Taipei
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taipei
Country [35] 0 0
Taiwan
State/province [35] 0 0
Yunlin County
Country [36] 0 0
United Kingdom
State/province [36] 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
Arcus Biosciences, Inc.
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
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
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/NCT05676931