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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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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.