Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
423
Countries
4
Sites
26
Advanced Non-Small Cell Lung Cancer
To assess the objective response rate (ORR) of immunotherapy-based combination therapy To assess the safety and tolerability of immunotherapy-based combination therapy
Key facts
- Sponsor
- Gilead Sciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Mar 2024 → ongoing
- Decision date (initial)
- 2023-11-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Arcus Biosciences, Inc. · Gilead Sciences, Inc.
External identifiers
- EU CT number
- 2022-502916-35-01
- ClinicalTrials.gov
- NCT05676931
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Dose response, Others, Pharmacokinetic
To assess the objective response rate (ORR) of immunotherapy-based combination therapy
To assess the safety and tolerability of immunotherapy-based combination therapy
Secondary objectives 3
- To assess the clinical activity of the immunotherapy-based combination therapy, based on investigator assessment according to RECIST v1.1, where applicable
- To describe the pharmacokinetic (PK) profile of investigation study treatments
- To describe the immunogenicity of investigational biologic study treatments
Conditions and MedDRA coding
Advanced Non-Small Cell Lung Cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Study Study period containing all arms
|
Randomised Controlled | None | A1: Domvanalimab + Zimberelimab: Domvanalimab and Zimberelimab, both administered by IV infusion A2: Domvanalimab + Zimberelimab: Domvanalimab and Zimberelimab, both administered by IV infusion A3: Quemliclustat + Zimberelimab: Quemliclustat and Zimberelimab, both administered by IV infusion B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy: Domvanalimab, Quemliclustat, and platinum doublet chemotherapy, all administered by IV infusion B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy: Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy: Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion C1: Quemliclustat + Zimberelimab + Docetaxel: Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion C2: Domvanalimab + Zimberelimab + Docetaxel: Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-502916-35-00 | A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer | Arcus Biosciences Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histologically or cytologically documented NSCLC with documented evidence of Stage IV metastatic NSCLC disease at the time of start of study treatment (per American Joint Committee on Cancer Version 8).
- ECOG performance status of 0 to 1.
- With ≥ 1 measurable target lesion(s) as per RECIST v1.1 criteria (Section 9.9) by investigator assessment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Organ function requirement: Adequate hematologic counts, Adequate hepatic function, Creatinine clearance
- Participants must provide adequate pretreatment tumor tissue from non-irradiated locations, either as a formalin-fixed, paraffin-embedded (FFPE) tissue block or freshly sectioned slides. Bone biopsies, cytology, and fine needle aspirates are not acceptable Archived tumor tissue blocks are acceptable if they were collected within the past 12 months and no anticancer treatment was received between tissue collection and enrollment. If a suitable archival tumor tissue sample is not available, the participant must be willing to undergo a pretreatment tumor biopsy.
Exclusion criteria 5
- Underlying medical conditions that, in the investigator’s or sponsor’s opinion, will make the administration of investigational products (IPs) hazardous
- Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
- Are receiving systemic steroids (> 10 mg/day prednisone equivalent) or other immunosuppressive medication ≤ 14 days before the initiation of the study treatment. Use of topical, inhalation, intranasal, and intraocular steroids will be permitted.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and assessed by the investigator
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Secondary endpoints 6
- OS
- PFS
- Disease control rate (DCR)
- Duration of response (DoR)
- Plasma or serum concentration of investigational study treatments and estimated PK parameters
- Percentage of biologic treatment-emergent antidrug antibody (ADA)-positive participants and ADA-negative participants
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 23
PRD9450057 · Product
- Active substance
- Quemliclustat
- Substance synonyms
- (((((2R,3S,4R,5R)-5-(6-Chloro-4-(((S)-1-(2-fluorophenyl)ethyl)amino)-1H-pyrazolo[3,4-b]pyridin-1-yl)-3,4-dihydroxytetrahydrofuran-2-yl)methoxy)(hydroxy)phosphoryl)methyl)phosphonic acid, AB680, AB-680
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 30400 mg milligram(s)
- Max treatment duration
- 304 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ARCUS BIOSCIENCES EUROPE LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD808124 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 3002152.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatine Hikma 450 mg/45 ml oplossing voor infusie
PRD6764493 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- BE535155
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung
PRD1969079 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 46297.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatine Hikma 450 mg/45 ml Infusionslösung
PRD6764401 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- BE535155
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatine Hikma 450 mg/45 ml solution pour perfusion
PRD6700936 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- BE535155
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paclitaxel AqVida 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD5797516 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 88689.00.00
- MA holder
- AQVIDA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD6701803 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 59091.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
PRD7936183 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 50666 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 304 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/004
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed NeoCorp 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD8577271 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 50666 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 304 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- 2204513.00.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed STADA 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD7905952 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 50666 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 304 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- 99025.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Hexal 25 mg/ml infuusiokonsentraatti, liuosta varten
PRD8233535 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 50666 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 304 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- 37193
- MA holder
- HEXAL A/S
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Ribosepharm 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD6597975 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 50666 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 304 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- 99024.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Hikma 160 mg/8 ml Konzentrat zur Herstellung einer Infusionslösung
PRD4495643 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 5800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 58 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- 93834.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel AqVida 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD2201801 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 5800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 58 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- 92726.00.00
- MA holder
- AQVIDA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Abraxane 5 mg/ml powder for dispersion for infusion.
PRD9254310 · Product
- Active substance
- Paclitaxel Albumin-Bound
- Substance synonyms
- PACLITAXEL ALBUMINE-BOUND
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1200 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- EU/1/07/428/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9450051 · Product
- Active substance
- Domvanalimab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 121600 mg milligram(s)
- Max treatment duration
- 304 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ARCUS BIOSCIENCES EUROPE LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD9450049 · Product
- Active substance
- Zimberelimab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 36480 mg milligram(s)
- Max treatment duration
- 304 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ARCUS BIOSCIENCES EUROPE LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Cisplatine Teva 1 mg/ml concentraat voor oplossing voor infusie
PRD3752946 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- BE331922
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatine 1 mg/ml PCH, concentraat voor oplossing voor infusie
PRD667481 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- RVG 101430
- MA holder
- PHARMACHEMIE BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 39021.01.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatine Teva 1 mg/ml solution à diluer pour perfusion.
PRD664978 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- BE331922
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatine Teva 1 Mg/Ml Konzentrat Zur Herstellung Einer Infusionslösung
PRD4141655 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- BE331922
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gilead Sciences Inc.
- Sponsor organisation
- Gilead Sciences Inc.
- Address
- 333 Lakeside Drive
- City
- Foster City
- Postcode
- 94404-1147
- Country
- United States
Scientific contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Aliri USA Inc. ORG-100052116
|
Colorado Springs, United States | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Resolian Bioanalytics ORL-000008614
|
Malvern, United States | Laboratory analysis |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Other |
| Precision For Medicine ORL-000011822
|
Bethesda, MD, United States | On site monitoring, Code 12, Other, Code 5 |
| Charles River Laboratories Inc. ORG-100011991
|
Reno, United States | Laboratory analysis |
| Pharmaceut ical Research Associates, Inc. ORL-000011821
|
Raleigh, NC, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Novotech (Australia) Pty Limited ORG-100045787
|
Pyrmont, Australia | Code 12, Code 5 |
| Cellcarta Naperville LLC ORG-100042145
|
Naperville, United States | Laboratory analysis |
| Icon Public Limited Company ORG-100042517
|
Dublin 18, Ireland | Other |
Locations
4 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 12 | 7 |
| Italy | Ongoing, recruitment ended | 25 | 5 |
| Poland | Ongoing, recruitment ended | 5 | 4 |
| Spain | Ongoing, recruitment ended | 58 | 10 |
| Rest of world
Korea, Republic of, Taiwan, United States, Georgia, United Kingdom, Australia
|
— | 323 | — |
Investigational sites
Hospital Foch
Oncologie Médicale, 40 Rue Worth, 92150, Suresnes
Hospices Civils De Lyon
Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Hospices Civils De Lyon
Service de Pneumologie, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Bordeaux
Department of Respiratory Diseases, Avenue De Magellan, 33600, Pessac
Hospices Civils De Lyon
Service de Pneumo-Oncologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Regional Lutte Contre Le Cancer
oncologie, Batiment Icans, 17 Rue Albert Calmette, Strasbourg
Institut De Cancerologie Strasbourg Europe
Oncologie Médicale, 17 Rue Albert Calmette, 67200, Strasbourg
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica, Largo Agostino Gemelli 8, 00168, Rome
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Unit of Thoracic Oncology, Via Piero Maroncelli 40, 47014, Meldola
Istituto Oncologico Veneto
U.O.C. Oncologia 2, Via Gattamelata 64, 35128, Padova
Azienda Sanitaria Territoriale Di Pesaro E Urbino
U.O.C. Oncologia-Stabilimento di Pesaro, Piazzale Carlo Cinelli N 4, 61121, Pesaro
Med Polonia Sp. z o.o.
Onkologii, Obornicka 262, 60-693, Poznan
Szpitale Pomorskie Sp. z o.o.
Oddział Onkologii Klinicznej - Leczenie 'Jednego Dnia', Ul. Powstania Styczniowego 1, 81-519, Gdynia
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Onkologii, Ul. Ceglana 35, 40-514, Katowice
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department of Lung Cancer and Thoracic Tumors, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Mutua Terrassa
Medical Oncology, Plaza del Dr. Robert 5, 08221, Terrassa
Hospital Vithas Valencia 9 de Octubre
Oncology, Calle Valle de la Ballestera, 59, Valencia
Hospital Universitario Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Micancer Center S.L.P.
Oncology, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona
Hospital Universitario Lucus Augusti
Medical Oncology, Rua Dr. Ulises Romero 1, 27003, Lugo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-05-31 | 2024-08-05 | 2025-09-08 | ||
| Italy | 2024-07-24 | 2025-07-17 | 2025-09-08 | ||
| Poland | 2024-08-22 | 2025-03-19 | 2025-09-08 | ||
| Spain | 2024-03-27 | 2024-04-03 | 2025-09-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 99 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-502916-35-01_redacted | 5 |
| Protocol (for publication) | D4_Patient facing documents_EN_DrToDrLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EN_GPorPrimaryOncLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EN_Patient Letter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EN_SSA WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_EN_SSB WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_EN_SSC WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_DrToDrLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_GPorPrimaryOncLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_Patient Letter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_SSA WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_SSB WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_SSC WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_FR_DrToDrLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_FR_GPorPrimaryOncLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_FR_Patient Letter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_FR_SSA WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_FR_SSB WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_FR_SSC WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_IT_DrToDrLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_IT_GPorPrimaryOncLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_IT_Patient Letter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_IT_SSA WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_IT_SSB WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_IT_SSC WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_PL_DrToDrLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PL_GPorPrimaryOncLetter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PL_Patient Letter_EDGE-Lung_2022-502916-35-01 | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PL_SSA WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_PL_SSB WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_PL_SSC WalletCard_EDGE-Lung_2022-502916-35-01 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EDGE-Lung_FR | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_EDGE-Lung | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_EDGE-Lung | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_PL_EDGE-Lung | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy IT_EDGE-Lung | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy IT_EDGE-Lung_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy_ES_EDGE-Lung | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy_FR_EDGE-Lung | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy_PL_EDGE-Lung | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study A_ES_EDGE-Lung | 10.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study A_FR_EDGE-Lung | 10.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study A_IT_EDGE-Lung | 10.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study A_PL_EDGE-Lung | 10.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study B_ES_EDGE-Lung | 11.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study B_FR_EDGE-Lung | 11.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study B_IT_EDGE-Lung | 11.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study B_PL_EDGE-Lung | 11.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study C_ES_EDGE-Lung | 11.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study C_FR_EDGE-Lung | 11.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study C_IT_EDGE-Lung | 11.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub-Study C_PL_EDGE-Lung | 11.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment after progression_FR_EDGE-Lung | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment after progression_IT_EDGE-Lung | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_treatment after progression_ES | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_treatment after progression_FR_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_treatment after progression_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_ES_EDGE-Lung_SSA | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_ES_EDGE-Lung_SSB | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_ES_EDGE-Lung_SSC | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_IT_EDGE-Lung_SSA | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_IT_EDGE-Lung_SSB | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_IT_EDGE-Lung_SSC | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_PL_EDGE-Lung_SSA | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_PL_EDGE-Lung_SSB | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_PL_EDGE-Lung_SSC | 3 |
| Subject information and informed consent form (for publication) | L2_Patient WalletCard SSA_FR_EDGE-Lung | 4.1 |
| Subject information and informed consent form (for publication) | L2_Patient WalletCard SSB_FR_EDGE-Lung | 4.1 |
| Subject information and informed consent form (for publication) | L2_Patient WalletCard SSC_FR_EDGE-Lung | 4.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Docetaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nab-paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nab-paclitaxel_TC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Carboplatine Hikma_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Carboplatine Hikma_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Carboplatine Hikma_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Carboplatine Hikma_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Carboplatine Hikma_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Carboplatine Hikma_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Carboplatine Hikma_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Carboplatine Hikma_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Cisplatine Teva_FR_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Pemetrexed Fresenius Kabi_EN_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Abraxane_EN_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Abraxane_EN_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Abraxane_EN_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Abraxane_EN_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Abraxane_EN_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Abraxane_EN_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Docetaxel Hikma_EN_EDGE-Lung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Paclitaxel Hikma Ribosepharm_EN_EDGE-Lung | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_EDGE-Lung_2022-502916-35-01 | 3.4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2022-502916-35 | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2022-502916-35 | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2022-502916-35-01 | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2022-502916-35-01 | 5 |
Application history
18 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-26 | France | Acceptable 2023-09-08
|
2023-11-24 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-12-05 | Acceptable 2023-09-08
|
2024-02-06 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-12-07 | 2024-03-18 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2023-12-20 | 2024-03-27 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-21 | France | Acceptable | 2024-02-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-06 | Acceptable | 2024-03-14 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-08 | France | Acceptable 2024-06-25
|
2024-06-25 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-17 | Acceptable | 2024-07-24 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-30 | France | Acceptable 2024-09-26
|
2024-09-26 |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-10-25 | France | Acceptable 2025-02-17
|
2025-02-17 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-01 | Acceptable | 2025-05-07 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-04-01 | Acceptable | 2025-05-16 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-04-01 | Acceptable | 2025-05-05 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-04-01 | France | Acceptable | 2025-04-22 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-17 | Acceptable | 2025-07-17 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-08-01 | Acceptable | 2025-09-10 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-08-05 | France | Acceptable | 2025-08-25 |
| 18 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-10-28 | France | Acceptable 2026-01-30
|
2026-02-03 |