Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
627
Countries
4
Sites
28
Solid Tumours
Dose Escalation: • To assess the safety and tolerability of a marlotamig monotherapy lead-in and marlotamig in combination with cemiplimab in patients with advanced solid tumors Dose Expansion: • To assess the preliminary efficacy of marlotamig in combination with cemiplimab with or without chemotherapy within selecte…
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 May 2024 → ongoing
- Decision date (initial)
- 2023-08-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501234-37-00
- ClinicalTrials.gov
- NCT04626635
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety, Others
Dose Escalation:
• To assess the safety and tolerability of a marlotamig monotherapy lead-in and marlotamig in combination with cemiplimab in patients with advanced solid tumors
Dose Expansion:
• To assess the preliminary efficacy of marlotamig in combination with cemiplimab with or without chemotherapy within selected advanced solid tumor-specific cohorts, as measured by objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1) and/or composite response criteria
Secondary objectives 8
- Dose Escalation: To characterize the pharmacokinetics (PK) of marlotamig alone and in combination with cemiplimab
- Dose Escalation:To assess the preliminary efficacy of marlotamig in combination with cemiplimab, as measured by ORR, overall survival (OS), progression free survival (PFS), duration of response (DOR), complete response (CR) rate, and disease control rate (DCR) per RECIST 1.1 and/or composite response criteria
- Dose Escalation: To assess immunogenicity of marlotamig and cemiplimab
- Dose Expansion: To assess the preliminary efficacy of marlotamig in combination with cemiplimab with or without chemotherapy within selected advanced solid tumor-specific cohorts of patients , as measured by OS, PFS, DOR, CR rate, and DCR per RECIST 1.1 and/or composite response criteria
- Dose Expansion: To assess the safety and tolerability of marlotamig in combination with cemiplimab with or without chemotherapy
- Dose Expansion: To characterize the PK of marlotamig alone and in combination with cemiplimab with or without chemotherapy
- Dose Expansion: To assess immunogenicity to marlotamig and cemiplimab with or without chemotherapy
- Dose Expansion: To assess the effect of marlotamig alone and in combination with cemiplimab with or without chemotherapy on patient-reported outcomes, including health related quality of life (HRQoL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC QLQ-CR29 (among CRC patients only), EORTC-QLQ-BR23 (breast cancer patients only), EORTC QLQ-LC13 (among NSCLC patients only) and EORTC QLQ-HN35 (among HNSCC patients only) and EQ-5D-5L
Conditions and MedDRA coding
Solid Tumours
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Study design 11 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Experimental: Dose Escalation Variety of mixed advanced solid tumor types
|
Not Applicable | None | ||
| 2 | Experimental: Dose Expansion E Microsatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases
|
Not Applicable | None | ||
| 3 | Experimental: Dose Expansion F MSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases)
|
Not Applicable | None | ||
| 4 | Experimental: Dose Expansion G Epidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI)
|
Not Applicable | None | ||
| 5 | Experimental: Dose Expansion H EGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy
|
Not Applicable | None | ||
| 6 | Experimental: Dose Expansion I Third line MSS-CRC with active liver metastases
|
Not Applicable | None | ||
| 7 | Experimental: Dose Expansion J Third line MSS-CRC without active liver metastases
|
Not Applicable | None | ||
| 8 | Experimental: Dose Expansion A Triple Negative Breast Cancer (TNBC)
|
Not Applicable | None | ||
| 9 | Experimental: Dose Expansion B Cutaneous Squamous Cell Carcinoma (CSCC)
|
Not Applicable | None | ||
| 10 | Experimental: Dose Expansion C (This cohort will not take place in EU) Non-Small Cell Lung Cancer (NSCLC)
|
Not Applicable | None | ||
| 11 | Experimental: Dose Expansion D Head and Neck Squamous Cell Carcinoma (HNSCC)
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
- Expansion Cohorts only: Is anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PDL1) naïve, defined as never having previously been treated with a drug that targets the PD-1
- Has at least 1 lesion that meets study criteria as defined in the protocol
- Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated
- Has adequate organ and bone marrow function as defined in the protocol
- In the judgement of the investigator, has a life expectancy of at least 3 months
Exclusion criteria 13
- Is currently participating in another study of a therapeutic agent
- Has participated in any study of an investigational agent or an investigational device within 4 weeks of the first administration of study drug as defined in the protocol
- Has received treatment with an approved systemic therapy within 4 weeks of the first administration of study drug or has not yet recovered (ie, grade 1 or baseline) from any acute toxicities
- Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as defined in the protocol
- Has received radiation therapy or major surgery within 14 days of the first administration of study drug or has not recovered (ie, grade 1 or baseline) from adverse events
- Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
- Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
- Has second malignancy that is progressing or requires active treatment as defined in the protocol
- Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or antiinflammatory equivalent) within 1-2 weeks prior to the first dose of study drug as defined in the protocol
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments as defined in the protocol
- Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
- Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug
- Has any ongoing inflammatory skin disease as defined in the protocol. NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- Dose escalation: The incidence of dose-limiting toxicities (DLTs) during the DLT period
- Dose escalation: Incidence and severity of treatment emergent adverse events (TEAEs)
- Dose escalation: Incidence and severity of adverse events of special interest (AESIs)
- Dose escalation: Incidence and severity of serious adverse events (SAEs)
- Dose escalation: Incidence and severity of grade ≥3 laboratory abnormalities
- Dose expansion: Objective Response Rate (ORR)
Secondary endpoints 16
- Dose escalation and dose expansion: Concentrations of marlotamig in serum
- Dose escalation: ORR
- Dose escalation and dose expansion: Progression free survival (PFS)
- Dose escalation and dose expansion: Duration of Response (DOR)
- Dose escalation and dose expansion: Disease control rate (DCR)
- Dose escalation and dose expansion: Complete response (CR) rate
- Dose escalation and dose expansion: Overall survival (OS)
- Dose escalation and dose expansion: Incidence of anti-drug antibodies (ADA) to marlotamig
- Dose escalation and dose expansion: Magnitude of ADA to marlotamig
- Dose escalation and dose expansion: Incidence of ADA to cemiplimab
- Dose escalation and dose expansion: Magnitude of ADA to cemiplimab
- Dose expansion: The incidence and severity of TEAEs
- Dose expansion: The incidence and severity of AESIs
- Dose expansion: The incidence and severity of SAEs
- Dose expansion: The incidence and severity of grade ≥3 laboratory abnormalities
- Dose expansion: Patient reported QoL, symptoms, functioning and general health status (per EORTC QLQ-C30, EORTC QLQ-CR29 in CRC patients, EORTC QLQ-BR23 in breast cancer patients, EORTC QLQ-LC13 in NSCLC patients, EORTC QLQ-HN35 in HNSCC patients, and EQ-5D-5L).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
LIBTAYO 350 mg concentrate for solution for infusion.
PRD7514335 · Product
- Active substance
- Cemiplimab
- Substance synonyms
- REGN2810
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FF06 — -
- Marketing authorisation
- EU/1/19/1376/001
- MA holder
- REGENERON IRELAND D.A.C.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Difference in pack, label and QP release sites.
LIBTAYO 350 mg concentrate for solution for infusion.
PRD7514333 · Product
- Active substance
- Cemiplimab
- Substance synonyms
- REGN2810
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FF06 — -
- Marketing authorisation
- EU/1/19/1376/001
- MA holder
- REGENERON IRELAND D.A.C.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Difference in pack, label and QP release sites.
LIBTAYO 350 mg concentrate for solution for infusion.
PRD7478447 · Product
- Active substance
- Cemiplimab
- Substance synonyms
- REGN2810
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FF06 — -
- Marketing authorisation
- EU/1/19/1376/001
- MA holder
- REGENERON IRELAND D.A.C.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Difference in pack, label and QP release sites.
LIBTAYO 350 mg concentrate for solution for infusion.
PRD7514334 · Product
- Active substance
- Cemiplimab
- Substance synonyms
- REGN2810
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FF06 — -
- Marketing authorisation
- EU/1/19/1376/001
- MA holder
- REGENERON IRELAND D.A.C.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Difference in pack, label and QP release sites.
Paclitaxel AqVida 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD5797516 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- 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
Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.
PRD1951612 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 17743
- MA holder
- ACCORD HEALTHCARE POLSKA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11853508 · Product
- Active substance
- REGN7075
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Authorisation status
- Not Authorised
- MA holder
- REGENERON PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9786536 · Product
- Active substance
- REGN7075
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Not Authorised
- MA holder
- REGENERON PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD10240124 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- 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
Pemetrexed EVER Pharma 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD8921237 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- 2204842.00.00
- MA holder
- EVER VALINJECT GMBH
- 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
- IV INFUSION
- 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
PRD13075171 · Product
- Active substance
- REGN7075
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Not Authorised
- MA holder
- REGENERON PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 3
Lonsurf 20 mg/8.19 mg film-coated tablets
PRD4021877 · Product
- Active substance
- Trifluridine
- Substance synonyms
- TRIFLUOROTHYMIDINE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01BC59 — -
- Marketing authorisation
- EU/1/16/1096/004
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153901 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lonsurf 15 mg/6.14 mg film-coated tablets
PRD4021653 · Product
- Active substance
- Trifluridine
- Substance synonyms
- TRIFLUOROTHYMIDINE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01BC59 — -
- Marketing authorisation
- EU/1/16/1096/001
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other, Code 5 |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Code 5 |
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | Other |
| Signant Health Management Limited ORG-100040504
|
Reading, United Kingdom | Other |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
Locations
4 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 91 | 13 |
| Netherlands | Ongoing, recruitment ended | 24 | 2 |
| Poland | Ongoing, recruitment ended | 32 | 3 |
| Spain | Ongoing, recruitment ended | 65 | 10 |
| Rest of world
United States, Israel, Turkey
|
— | 415 | — |
Investigational sites
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Antoine Lacassagne
Centre Antoine Lacassagne, 33 Avenue De Valombrose, 06189, Nice Cedex 2
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Medical Oncology, 185 Rue Raymond Losserand, 75014, Paris
Hospital Hotel Dieu
Département de dermatologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Institut Gustave Roussy
Drug Development Department (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Centre Hospitalier Universitaire De Lille
Département de dermatologie, Rue Michel Polonovski, 59037, Lille Cedex
Centre Jean Perrin
Medical Oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Unite De Recherche Clinique HIA Begin
Medical Oncology, 69 Avenue De Paris, 94160, Saint-Mande
Centre Hospitalier Lyon Sud
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Leon Berard
Centre Leon-Berard, 28 Rue Laennec, 69008, Lyon
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
CRU, Plesmanlaan 121, 1066 CX, Amsterdam
Med Polonia Sp. z o.o.
N/A, Obornicka 262, 60-693, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotowrów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Centrum Medyczne Damiana Holding Sp. z o.o.
Dom Lekarski - Ambulatorium Struga, Ul. Andrzeja Struga 42, 70-784, Szczecin
Hospital Universitario De Salamanca
Dermatology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Clinic De Barcelona
Dermatology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari General De Catalunya
Oncology, Calle Pedro I Pons 1, 08195, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Instituto Multidisciplinar De Oncologia S.A.
Oncology, Calle De Joaquin Costa 28, 28002, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 | 2024-05-07 | 2024-05-07 | 2026-02-26 | ||
| Netherlands | 2025-05-13 | 2025-06-05 | 2026-05-11 | ||
| Poland | 2025-03-28 | 2025-06-04 | 2026-03-04 | ||
| Spain | 2024-05-15 | 2024-05-15 | 2026-03-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 53 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-501234-37-00_Redacted | Amendment7 |
| Protocol (for publication) | D4_Screen Reports_enGB_Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_esES_Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_frFR_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_R7075-ONC-2009_Recruit ICF process_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_R7075-ONC-2009_Recruit-ICF process | 1.0 |
| Recruitment arrangements (for publication) | K1_R7075-ONC-2009_Recruit-ICF process_FR_Fre_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_R7075-ONC-2009_Recruitment arrangements_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R7075-ONC-2009_Recruit materiel_Blank Statement_FR_Eng_FP | 1 |
| Recruitment arrangements (for publication) | K2_R7075-ONC-2009_Recruitment Material Blank Statement_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R7075-ONC-2009_Recruitment Material Statement | N/A |
| Recruitment arrangements (for publication) | K2_R7075-ONC-2009_Recruitment material statement_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009 SIS-ICF_continue participation_FR_Fre_FP | 1 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009 SIS-ICF_FBR_FR_Fre_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009 SIS-ICF_Main_FR_Fre_FP | 9.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009 SIS-ICF_PGx_FR_Fre_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009 SIS-ICF_Pregant partner_FR_Fre_FP | 1 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF Continuacion_es | 1.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF FBR_es | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF Main_es | 8.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF PGx_es | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF Pregnant Partner_es | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Continued Participation_en | 1.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Continued Participation_FP | 1.2 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Continued participation_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Continued participation_zh_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_FBR_en | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_FBR_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_FBR_zh_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Main ICF_zh_FP | 8.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Main_en | 6.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_PGx_en | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_PGx_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_PGx_zh_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_PP_en | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_PP_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_PP_zh_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7075-ONC-2009_SIS-ICF_Pregnant Partner_FP | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin | 30Jun2025 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Pemetrexed | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2022_501234_37_00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2022_501234_37_00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2022_501234_37_00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2022_501234_37_00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2022_501234_37_00 | 3.0 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-15 | Spain | Acceptable 2023-08-23
|
2023-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-05 | Spain | Acceptable 2024-03-08
|
2024-03-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-10 | Spain | Acceptable 2024-06-21
|
2024-06-21 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-08-13 | Acceptable 2024-06-21
|
2024-11-07 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-08-13 | 2024-11-11 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-15 | Spain | Acceptable | 2024-10-30 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-27 | Acceptable | 2024-11-27 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-18 | Spain | Acceptable 2025-04-21
|
2025-04-21 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-17 | Spain | Acceptable | 2025-07-02 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-17 | Acceptable | 2025-07-16 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-01 | Spain | Acceptable | 2025-08-01 |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-03 | Spain | Acceptable | 2025-09-16 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-01-30 | Spain | Acceptable 2026-04-16
|
2026-04-20 |