Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
132
Countries
7
Sites
49
Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
To compare PFS of selpercatinib with the combination of platinum-based (carboplatin or cisplatin) therapy, pemetrexed, and pembrolizumab in patients with advanced or metastatic RET fusion-positive NSCLC To compare PFS of selpercatinib with the combination of platinum-based (carboplatin or cisplatin) and pemetrexed th…
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Feb 2020 → ongoing
- Decision date (initial)
- 2024-05-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506783-14-00
- EudraCT number
- 2019-001979-36
- WHO UTN
- U1111-1302-4716
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacogenetic, Efficacy, Pharmacokinetic
To compare PFS of selpercatinib with the combination of platinum-based (carboplatin or cisplatin) therapy, pemetrexed, and pembrolizumab in patients with advanced or metastatic RET fusion-positive NSCLC
To compare PFS of selpercatinib with the combination of platinum-based (carboplatin or cisplatin) and pemetrexed therapy, with or without pembrolizumab, in patients with advanced or metastatic RET fusion-positive NSCLC
Conditions and MedDRA coding
Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Participants must have advanced/metastatic non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation therapy
- Participants must have a RET gene fusion and sufficient tumor tissue available for confirmatory testing
- Participants must be in fair to good health and not Have another serious medical condition
- Participants must not have had prior chemotherapy for metastatic lung cancer. chemotherapy in the adjuvant/neoadjuvant setting is permitted
- Participants must not have disease that has spread to the brain and is causing symptoms
- Participants must be able to swallow capsules
- Participants must be willing to use highly effective contraception during the study
Exclusion criteria 1
- Participants must not have a heart condition that puts you at risk for abnormal heart rhythms.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS per REIST 1.1 by BICR
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB193120 · Substance
- Active substance
- Selpercatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Drug substance (DS) for clinical trials (CTs) and for commercial use (CU) have been produced utilizing the same sequence of synthetic steps, starting materials, and intermediates. Same manufacturing process and unit formula are utilized for CTs and CU DP. Materials, may be manufactured, packaged, and labelled at different facilities. Commitments relative to materials, specifications, and shelf-life for CT and CU materials may be different but of comparable quality and ensure product safety.
SUB193120 · Substance
- Active substance
- Selpercatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Drug substance (DS) for clinical trials (CTs) and for commercial use (CU) have been produced utilizing the same sequence of synthetic steps, starting materials, and intermediates. Same manufacturing process and unit formula are utilized for CTs and CU DP. Materials, may be manufactured, packaged, and labelled at different facilities. Commitments relative to materials, specifications, and shelf-life for CT and CU materials may be different but of comparable quality and ensure product safety.
Comparator 4
SCP11423984 · ATC
- Active substance
- Pemetrexed Disodium
- Route of administration
- INFUSION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — PEMETREXED
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labelling
SCP6094344 · ATC
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, CT P51, SYS6036, QL-2107, CMAB820, ABP 234
- Route of administration
- INFUSION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC18 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labelling
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Route of administration
- INFUSION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labelling
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INFUSION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging and labelling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 14
| Organisation | City, country | Duties |
|---|---|---|
| Azenta ORL-000001999
|
Burlington, United States | Other |
| Rebar Interactive LLC ORG-100045545
|
Austin, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Code 5 |
| Colpitts ORL-000005241
|
Edinburgh, Scotland, United Kingdom | Other |
| Labcorp Asia Pte Ltd ORL-000005234
|
Singapore, Singapore | Laboratory analysis |
| Brightech International LLC ORL-000002985
|
Somerset, New Jersey, United States | Code 10 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Labcorp Central Laboratory Services Sàrl ORL-000005229
|
Geneva, Switzerland | Laboratory analysis |
| Pharmaserve Lilly S.A.C.I. ORL-000004791
|
Kifissia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Data management |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other, Laboratory analysis |
Locations
7 EU/EEA countries · 49 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 4 | 7 |
| France | Ongoing, recruitment ended | 5 | 4 |
| Germany | Ongoing, recruitment ended | 5 | 6 |
| Greece | Ongoing, recruitment ended | 2 | 1 |
| Italy | Ongoing, recruitment ended | 16 | 7 |
| Netherlands | Ongoing, recruitment ended | 3 | 3 |
| Spain | Ongoing, recruitment ended | 7 | 21 |
| Rest of world
Korea, Republic of, Hong Kong, Australia, Turkey, Brazil, China, United Kingdom, Argentina, Taiwan, Mexico, Ukraine, Canada, Japan, Russian Federation, Israel
|
— | 90 | — |
Investigational sites
A.Z. Sint-Maarten
NA, Liersesteenweg 435, 2800, Mechelen
UZ Leuven
Respiratory Oncology, Herestraat 49, 3000, Leuven
Algemeen Ziekenhuis Delta
Pneumology, Deltalaan 1, 8800, Roeselare
UZ Brussel
Medische Oncologie, Laarbeeklaan 101, 1090, Jette
Vitaz
NA, Moerlandstraat 1, 9100, Sint-Niklaas
Universitair Ziekenhuis Gent
Pneumonolgy, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Trial Office, Place Louise Godin 15, 5000, Namur
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Hopitaux Universitaires Paris Centre-Hopital Cochin
Pneumology and Physiology Department, 27 Rue du Faubourg Saint-Jacques, Bâtiment Cornil-Brissaut, Paris
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology and Physiology Department, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Asklepios Klinik Gauting GmbH
Oncology, Robert-Koch-Allee 2, 82131, Gauting
Franziskus Hospital Harderberg
N/A, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
Charite Universitaetsmedizin Berlin KöR
N/A, Hindenburgdamm 30, Lichterfelde, Berlin
Klinikverbund Allgaeu gGmbH
N/A, Im Stillen 2, 87509, Immenstadt I. Allgäu
Thoraxklinik Heidelberg gGmbH
Thoraxklinik Heidelberg gGmbH, Roentgenstrasse 1, Rohrbach, Heidelberg
LungenClinic Grosshansdorf GmbH
Onkologie, Woehrendamm 80, 22927, Grosshansdorf
Athens Medical Center S.A.
Oncology Clinic, Pylea, Asklipiou 10, Thessaloniki
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncologia Medica Ardizzoni, Via Pietro Albertoni 15, 40138, Bologna
ASST Grande Ospedale Metropolitano Niguarda
Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncologia medica Toraco-Polmonare, Via Mariano Semmola 142, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Medical Oncology, Largo Agostino Gemelli 8, 00168, Rome
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncologia Polmonare, Regione Gonzole 10, 10043, Orbassano
Centro Di Riferimento Oncologico Di Aviano
medical oncology, Via Franco Gallini 2, 33081, Aviano
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amsterdam UMC Stichting
Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Jeroen Bosch Ziekenhuis
Pulmonology, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
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
Clinica Universidad De Navarra
Medical Oncology, Avenue Pio XII 36, 31008, Pamplona
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital General Universitario Dr. Balmis
Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario De Jaen
Medical Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital De La Santa Creu I Sant Pau
Medical Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario De Navarra
Medical Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Clinica Universidad De Navarra
Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Son Llatzer
Oncology, Carretera De Manacor Km 4, 07198, Palma
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 |
|---|---|---|---|---|---|
| Belgium | 2020-02-24 | 2020-03-16 | 2022-05-13 | ||
| France | 2020-07-23 | 2020-09-22 | 2022-05-05 | ||
| Germany | 2020-09-10 | 2020-10-07 | 2021-11-24 | ||
| Greece | 2020-06-02 | 2020-07-07 | 2021-12-02 | ||
| Italy | 2020-04-23 | 2020-07-15 | 2022-07-07 | ||
| Netherlands | 2020-07-14 | 2021-02-03 | 2022-07-05 | ||
| Spain | 2020-05-18 | 2020-07-02 | 2023-04-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 106 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506783-14-00_Redacted | g |
| Protocol (for publication) | D1_Protocol_2023-506783-14-00_GR_Redacted | g |
| Protocol (for publication) | D4_Patient Documents Copyright | 1.0 |
| Recruitment arrangements (for publication) | JZJC_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_JZJC_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_JZJC_Blank document for Recruitment Arrangement_Recruitment closed | 1.1 |
| Recruitment arrangements (for publication) | K1_JZJC_Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_JZJC_Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_JZJC_Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Patient Card DE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Patient Card DU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Patient Card ENG | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Patient Card FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Thank You card DU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Thank You card FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Visit Guide DU | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Visit Guide FR | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_VisitGuide_tracked changes ENG | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum_Beyond Disease Progression_GR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum_Prescreening_GR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Crossover_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_SoC_Main_Crossover_GR__Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_SoC_Main_Crossover_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum ICF Prescreening DU | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum ICF Prescreening ENG | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum ICF Prescreening FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum ICF_treatment beyond progression DU | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum ICF_treatment beyond progression ENG | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum ICF_treatment beyond progression FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cross over ICF DU_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cross over ICF ENG_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cross over ICF FR_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF DU_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF ENG_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF FR_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of changes 1_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes ICF Main and Crossover_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes ICF Main and Crossover_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes ICF Main and Crossover_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Addendum_Progression | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ ICF Crossover_ ITA_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ ICF Main_ ITA_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Privacy Crossover_ ITA_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Privacy Main_ ITA_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Progression_ IT_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Prescreening_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cross-Over_Addendum_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cross-over_adults_and_option_post_progression | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cross-over_adults_and_option_post_progression_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_Redacted | 16 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 19 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Addendum_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_adults_and_option_post_progression | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_adults_and_option_post_progression_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Progression | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes 1_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes 2_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF Main and Crossover_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF Main and Crossover_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment change | 2.0 |
| Subject information and informed consent form (for publication) | L2 Other subject information material Study Guide | 3 |
| Subject information and informed consent form (for publication) | L2_Gp Letter_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Appt Reminder Card_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Patient Card_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank You Card_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Visit Guide_GR | 3 |
| Subject information and informed consent form (for publication) | L2_Patient Card_ITA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Thank you Card_ITA | 1.0 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Patient card | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Blanket Statement - Document not published anymore | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | Blanket Statement - Document not published anymore | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | Blanket Statement - Document not published anymore | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed_no longer in use | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506783-14-00_ENG | g |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506783-14-00_ENG_Track changed | g |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506783-14-00_GR | g |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506783-14-00_GR_Track Changes | g |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2023-506783-14 | g |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2023-506783-14 | g |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2023-506783-14 | g |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis NL_2023-506783-14-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_2023-506783-14-00 ES | g |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_2023-506783-14-00_ES TC | g |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_2023-506783-14-00_IT | f |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_MS_2023-506783-14-00_FR_Unapplied | f |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_MS_2023-506783-14-00_NL_Redacted | g |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-08 | Italy | Acceptable 2024-05-14
|
2024-05-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-03 | Italy | Acceptable | 2024-11-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-23 | Italy | Acceptable 2025-05-05
|
2025-05-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-08 | Italy | Acceptable 2025-09-29
|
2025-09-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-10 | Italy | Acceptable 2026-02-27
|
2026-03-02 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-09 | Italy | Acceptable 2026-02-27
|
2026-03-09 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-26 | Acceptable 2026-06-01
|
2026-06-02 |