Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
137
Countries
6
Sites
37
Advanced Non-Small Cell Lung Cancer
Evaluate the efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for advanced NSCLC patients with KRAS G12C mutation.
Key facts
- Sponsor
- Mirati Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Oct 2024 → ongoing
- Decision date (initial)
- 2023-09-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Mirati Therapeutics, Inc.
External identifiers
- EU CT number
- 2023-503714-77-00
- ClinicalTrials.gov
- NCT05609578
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Pharmacogenomic, Safety, Pharmacokinetic
Evaluate the efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for advanced NSCLC patients with KRAS G12C mutation.
Secondary objectives 3
- Characterize the safety and tolerability of the combination regimen in the selected population.
- Characterize the pharmacokinetics (PK) of adagrasib
- Evaluate secondary efficacy endpoints using the combination regimen in the selected population.
Conditions and MedDRA coding
Advanced Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 2 Trial of Combination Therapies with Adagrasib in Advanced NSCLC with KRAS G12C Mutation In all cohorts, Adagrasib will be administered orally BID on a continuous basis. Patient enrollment will occur sequentially into Cohort C first following an appropriate safety lead-in (SLI). The totality of data for approximately first 3 to 12 patients will be internally reviewed prior to opening enrollment into Cohort E. Following 9 months on study treatment, individual patients may switch to pembrolizumab. Pembrolizumab treatment may continue for up to 31-35 cycles depending on the assigned cohort or approximately 24 months, in accordance with local approved labeling.
|
Randomised Controlled | None | Cohort A: 45 patients will be enrolled to receive adagrasib 400 mg twice daily (BID) for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles. This cohort is closed to further enrollment. Cohort C: 45 patients will be enrolled to receive adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles Cohort E: 45 patients will be enrolled to receive adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation. a. Cohort A* (closed): squamous or nonsquamous histology b. Cohorts C and E*: nonsquamous histology only
Exclusion criteria 3
- Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy (CIT in Cohorts A and E only), any therapy targeting KRAS G12C mutation (eg, sotorasib) , or received maintenance therapy, eg, pembrolizumab and/or pemetrexed following completion 4-6 cycles of a platinum-based regimen administered in the first-line setting (Cohort C only)
- Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment.
- Active brain metastases.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Cohorts A and E: Objective response rate (ORR), as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- Cohort C: PFS at 6 months (PFS6)
Secondary endpoints 4
- Cohorts C and E: Dose-limiting toxicities (DLTs) during safety lead-in (SLI)
- Safety characterized by type, incidence, severity, timing, seriousness, and relationship to study treatment of adverse events (AEs) and laboratory abnormalities
- Summary statistics of adagrasib concentrations
- Secondary efficacy endpoints: Duration of response (DOR)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
PRD8665001 · Product
- Active substance
- Adagrasib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 588000 mg milligram(s)
- Max treatment duration
- 735 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- NOTASSIGN — -
- MA holder
- MIRATI THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 23250 mg milligram(s)
- Max treatment duration
- 735 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 15500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 735 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2325 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 735 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 7000 mg milligram(s)
- Max treatment duration
- 735 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 15500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 735 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 15500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 735 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 15500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 735 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 8 mg milligram(s)
- Max total dose
- 744 mg milligram(s)
- Max treatment duration
- 735 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09593MIG · Substance
- Active substance
- Palonosetron
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 9999 µg microgram(s)
- Max total dose
- 9999 µg microgram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mirati Therapeutics Inc.
- Sponsor organisation
- Mirati Therapeutics Inc.
- Address
- Route 206, Province Line Road Province Line Road
- City
- Princeton
- Postcode
- 08543
- Country
- United States
Scientific contact point
- Organisation
- Mirati Therapeutics Inc.
- Contact name
- Mirati Study Locator
Public contact point
- Organisation
- Mirati Therapeutics Inc.
- Contact name
- Mirati Study Locator
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other |
| Azenta Germany GmbH ORG-100039257
|
Griesheim, Germany | Other |
| Labconnect LLC ORG-100042800
|
Johnson City, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 2, Code 5, Code 8, Code 9 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, Interactive response technologies (IRT), E-data capture |
| Resolution Bioscience, Inc. ORL-000001531
|
Kirkland, United States | Other |
| Labcorp Central Laboratory Services ORL-000001529
|
United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Tempus AI Inc. ORG-100044006
|
Chicago, United States | Other |
| Icon (Lr) Limited ORG-100042612
|
Dublin 18, Ireland | Other |
| Sharp Clinical Services LLC ORG-100011791
|
Bethlehem, United States | Other |
Locations
6 EU/EEA countries · 37 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 25 | 10 |
| Greece | Ended | 10 | 3 |
| Hungary | Ongoing, recruitment ended | 13 | 4 |
| Italy | Ongoing, recruitment ended | 20 | 9 |
| Poland | Ended | 13 | 3 |
| Spain | Ongoing, recruitment ended | 20 | 8 |
| Rest of world
United States
|
— | 36 | — |
Investigational sites
Hopital Tenon
Pneumology & Thoracic Oncology, 4 Rue De La Chine, 75970, Paris Cedex 20
Institut Paoli-Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Francois Baclesse
Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Hospital Foch
Medical Oncology, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Intercommunal Creteil
Pneumology, 40 Avenue De Verdun, 94000, Creteil
Centre Hospitalier Universitaire De Toulouse
Pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
Institut De Cancerologie De L Ouest
Oncology, 15 Rue Andre Boquel, 49100, Angers
Institut Gustave Roussy
Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Metropolitan Hospital
4th Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
General University Hospital Of Larissa
Oncology Department, P. O. Box 1425, 411 10, Larissa
University General Hospital Of Heraklion
Oncology Department, Stavrakia And Voutes, 715 00, Heraklion
Orszagos Onkologiai Intezet
Gyógyszerter ápiás Központ, Mellkasi és Hasüregi Daganatok és Kliinkai Farmakológiai Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Koranyi National Institute For Pulmonology
VI. Pulmonológiai Osztály, Koranyi Frigyes Ut 1, 1121, Budapest XII
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
I. Pulmonológiai Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Tuedogyogyintezet Toeroekbalint
Onkológiai Osztály, Munkacsy Mihaly Utca 70, 2045, Torokbalint
European Institute Of Oncology S.r.l.
Divisione di Oncologia, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Unita Sanitaria Locale Della Romagna
Oncologia, Viale Dante 10, 48022, Lugo
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
AORN San Giuseppe Moscati Avellino
UO Oncologia Medica, Contrada Amoretta, 83100, Avellino
Azienda Unita Sanitaria Locale Della Romagna
Oncologia, Viale Vincenzo Randi 5, 48121, Ravenna
Careggi University Hospital
SODc Oncologia Medica e Clinica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Sanitaria Locale Al Di Alessandria
Oncologia, Via Venezia N 6, 15121, Alexandria
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncologia, Regione Gonzole 10, 10043, Orbassano
Azienda Unita Sanitaria Locale Della Romagna
Oncologia, Viale Stradone 9, 48018, Faenza
Med Polonia Sp. z o.o.
Clinical Trials Department, Obornicka 262, 60-693, Poznan
Instytut Msf Sp. z o.o.
N/A, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Klinika Onkologii (Oncology Clinic), Ulica Szaserow 128, 04-141, Warsaw
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Complexo Hospitalario Universitario A Coruna
Medical Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Son Llatzer Hospital
Medical Oncology, Carretera Manacor Km 4 Son Ferriol, 07198, Palma De Mallorca
Hospital Universitario Virgen De La Macarena
Medical Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinico Universitario Lozano Blesa
Unidad de Investigación Traslacional-Ensayos Clínicos Oncologia Medica, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario La Paz
Medical Oncology, Paseo Castellana 261, 28046, Madrid
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
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 | 2023-11-15 | 2024-12-16 | 2025-05-28 | ||
| Greece | 2023-12-04 | 2025-05-28 | 2025-03-11 | 2025-05-28 | |
| Hungary | 2023-12-08 | 2024-11-04 | 2025-05-28 | ||
| Italy | 2023-12-11 | 2024-11-29 | 2025-05-28 | ||
| Poland | 2023-10-17 | 2025-10-16 | 2025-03-26 | 2025-05-28 | |
| Spain | 2023-10-17 | 2024-01-04 | 2025-05-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 6 · Art. 38 CTR
Temporary halt TH-26505
- Halt date
- 2024-05-15
- Member states concerned
- Poland
- Publication date
- 2024-05-24
- Reason
- Sponsor decision
- Explanation
- A recruitment and enrollment hold for subjects into Cohort C will be on hold until Protocol Version 5 is submitted and approved in all member states.
- Follow-up measures
- Pending approval for Protocol Amendment 5
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-26504
- Halt date
- 2024-05-15
- Member states concerned
- Spain
- Publication date
- 2024-05-24
- Reason
- Sponsor decision
- Explanation
- A recruitment and enrollment hold for subjects into Cohort C will be on hold until Protocol Version 5 is submitted and approved in all member states.
- Follow-up measures
- Pending approval for Protocol Amendment 5
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-26503
- Halt date
- 2024-05-15
- Member states concerned
- Italy
- Publication date
- 2024-05-24
- Reason
- Sponsor decision
- Explanation
- A recruitment and enrollment hold for subjects into Cohort C will be on hold until Protocol Version 5 is submitted and approved in all member states.
- Follow-up measures
- Pending approval for Protocol Amendment 5
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-26502
- Halt date
- 2024-05-15
- Member states concerned
- Hungary
- Publication date
- 2024-05-24
- Reason
- Sponsor decision
- Explanation
- A recruitment and enrollment hold for subjects into Cohort C will be on hold until Protocol Version 5 is submitted and approved in all member states.
- Follow-up measures
- Pending approval for Protocol Amendment 5
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-26501
- Halt date
- 2024-05-15
- Member states concerned
- Greece
- Publication date
- 2024-05-30
- Reason
- Sponsor decision
- Explanation
- A recruitment and enrollment hold for subjects into Cohort C will be on hold until Protocol Version 5 is submitted and approved in all member states.
- Follow-up measures
- Pending approval for Protocol Amendment 5
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-26500
- Halt date
- 2024-05-15
- Member states concerned
- France
- Publication date
- 2024-05-24
- Reason
- Sponsor decision
- Explanation
- A recruitment and enrollment hold for subjects into Cohort C will be on hold until Protocol Version 5 is submitted and approved in all member states.
- Follow-up measures
- Pending approval for Protocol Amendment 5
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-03-06
- Type
- 3
- Reason
- 5
- Immediate action required
- Yes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 92 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Benefit Risk 2023-503714-77-00 Redacted | 2 |
| Protocol (for publication) | D1_Protocol_2023-503714-77_Admin Letter 2_Redacted | N/A |
| Protocol (for publication) | D1_Protocol_2023-503714-77_Admin Letter 3_Public Statement | N/A |
| Protocol (for publication) | D1_Protocol_2023-503714-77_Admin Letter_Redacted | N/A |
| Protocol (for publication) | D1_Protocol_2023-503714-77_Greek_redacted | 5.1 |
| Protocol (for publication) | D1_Protocol_2023-503714-77_redacted | 5.1 EU |
| Protocol (for publication) | D1_Protocol_Risk Benefit Assesment_2023-503714-77_Greek_redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_EL_Recruitment procedure | 1 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Procedure | 1 |
| Recruitment arrangements (for publication) | K1_FR_Recruitment Procedure_Bilingual | 2 |
| Recruitment arrangements (for publication) | K1_HU_Recruitment Procedure | 1 |
| Recruitment arrangements (for publication) | K1_IT_Recruitment Procedure | 1 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment Procedure_Polish | 1 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment material_HCPBrochure_Hungarian | 1 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment material_HCPLetter_Hungarian | 1 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment material_HCPReferralCard_Hungarian | 1 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Continuation ICF_Greek | 3.3 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main ICF Addendum_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_Greek_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Partner Pregnancy_Greek_redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnancy_Greek | 3.3 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Prescreening_Greek_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_SCOUT Caregiver_Greek_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_SCOUT_Greek_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Continuation_Spanish | 3.2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main Addendum_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pre-Screening_Spanish_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnancy Follow Up_Spanish | 3.2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnancy Partner Follow Up_Spanish_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Scout_Spanish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Continuation_French | 3.3 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main ICF Addendum_French | 1.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Patient Pregnancy_French_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pre-screening_French_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnancy Partner_French_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Scout_French_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Genetic_Hungarian_redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Genetic_Hungarian_redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Continuation_Hungarian | 3.2 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main Addendum_Hungarian | 1.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pre-screening_Hungarian_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pregnant Participant_Hungarian | 4.2 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pregnant Partner_Hungarian_redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Scout ICF_Hungarian_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Addendum_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Continuation_Italian | 3.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Main_Italian_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Partner Pregnancy_Italian_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Patient Pregnancy_Italian | 4.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_PreScreening_Italian_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Privacy_Italian_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Addendum_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Continuation_Polish | 3.2 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pre-Screening_Polish_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnancy Follow Up_Polish | 4.1 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnant Partner_Polish_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Scout Clinical Reimbursement_Polish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_HU_List of submitted patient materials_Hungarian | 1.0 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_Patient Dosing Diary_Once Daily_Hungarian | 2.0 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_Patient Dosing Diary_Twice Daily_Hungarian | 2.0 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_Subject Card_Hungarian | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Carboplatin_Accord | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Carboplatin_Accord_Spanish | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Carboplatin_CARBO-cell | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Carboplatin_CARBO-cell_German | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cisplatin_Accord_BV | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cisplatin_Accord_BV_German | .03 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cisplatin_Accord_SLU | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cisplatin_Accord_SLU_Spanish | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Pembrolizumab | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Pemetrexed_Alimta | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Pemetrexed_Fresenius_Kabi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Pemetrexed_Fresenius_Kabi_German | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Pemetrexed_STADA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Pemetrexed_STADA_German | 1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-503714-77 | 3 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-503714-77_French | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-503714-77_Greek | 3 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-503714-77_Hungarian | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-503714-77_Italian | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-503714-77_Polish | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-503714-77_Spanish | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503714-77_French_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503714-77_Greek_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503714-77_Hungarian_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503714-77_Italian_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503714-77_Polish_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503714-77_Spanish_redacted | 5.0 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-31 | Spain | Acceptable 2023-09-18
|
2023-09-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-26 | Acceptable 2023-09-18
|
2023-10-26 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-12-11 | Acceptable 2023-09-18
|
2023-12-11 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-12-18 | Acceptable 2023-09-18
|
2023-12-18 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-21 | Spain | Acceptable 2024-04-05
|
2024-04-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-19 | Acceptable | 2024-05-15 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-19 | Acceptable | 2024-05-20 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-19 | Acceptable | 2024-06-18 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-07 | Spain | Acceptable 2024-10-01
|
2024-10-01 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-11-06 | Spain | Acceptable 2024-10-01
|
2024-11-06 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-03 | Spain | Acceptable 2025-09-08
|
2025-09-09 |