Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
75
Countries
5
Sites
15
Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
1. To estimate the incidence of pCR in the resected primary tumor and lymph nodes assessed by BIPR following administration of investigational agents with various combinations of chemotherapy and pembrolizumab. 2. To estimate the extent of residual viable tumor in the resected lung tumor/lymph node sections in relation…
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Mar 2025 → ongoing
- Decision date (initial)
- 2025-06-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-509234-19-00
- WHO UTN
- U1111-1299-6753
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
1. To estimate the incidence of pCR in the resected primary tumor and lymph nodes assessed by BIPR following administration of investigational agents with various combinations of chemotherapy and pembrolizumab.
2. To estimate the extent of residual viable tumor in the resected lung tumor/lymph node sections in relation to the total carcinoma area assessed by BIPR.
Secondary objectives 5
- To estimate EFS by either biopsy assessed by a local pathologist or by imaging assessed by the investigator using RECIST 1.1.
- To estimate OS.
- To estimate DMFS.
- To estimate the OR rate as assessed by the investigator according to RECIST 1.1.
- To evaluate the safety and tolerability of investigational treatment combinations followed by surgery and adjuvant pembrolizumab, including surgical outcomes, and feasibility.
Conditions and MedDRA coding
Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10029514 | Non-small cell lung cancer NOS | 10029104 |
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506933-32-00 | KEYMAKER-U01 Master Study: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with either Pembrolizumab in Combination with Chemotherapy or with Pembrolizumab Alone in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Treatment Naïve Patients with PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC) | Merck Sharp & Dohme LLC |
| 2023-506932-33-00 | KEYMAKER-U01 Substudy 1: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with Pembrolizumab in Combination with Chemotherapy in Treatment-Naive Patients with Advanced Non-small Cell Lung Cancer (NSCLC) | Merck Sharp & Dohme LLC |
| 2023-506934-56-00 | KEYMAKER-U01 Master Study: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with either Pembrolizumab in Combination with Chemotherapy or with Pembrolizumab Alone in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated with anti-PD-(L)1 Therapy | Merck Sharp & Dohme LLC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Has previously untreated resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC), confirmed by pathology or imaging
- Able to undergo protocol therapy, including necessary surgery
- Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.
- Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.
Exclusion criteria 16
- Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.
- Has Grade ≥2 peripheral neuropathy
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy.
- Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) [qualitative]) infection.
- Known history of human immunodeficiency virus (HIV) infection
- History of allogeneic tissue/solid organ transplant
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Pathological Complete Response (pCR)
- Percent Residual Viable Tumor (%RVT)
Secondary endpoints 11
- Percentage of Participants Who Report at Least 1 Adverse Event (AE)
- Percentage of Participants Who Discontinue Study Treatment Due to an AE
- Event-free Survival (EFS)
- Overall Survival (OS)
- Distant Metastasis-Free Survival (DMFS)
- Objective Response Rate (ORR)
- Percentage of Participants Who Experience a Perioperative Complication
- Mean Length of Length of Hospital Stay
- Percentage of Participants Who Require Hospital Readmission after Discharge
- Mean Length of Surgery
- Percentage of Participants Who Require a Blood Transfusion
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
PRD11447874 · Product
- Active substance
- Sacituzumab Tirumotecan
- Substance synonyms
- Humanised IgG1 monoclonal antibody against TROP2, conjugated to KL610023, SKB264, MK-2870, Humanised IgG1 monoclonal antibody against TROP2, conjugated to sulfonylpyrimidine-polyethyleneglycol-lysine-methanesulfonyl belotecan
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 3400 mg milligram(s)
- Max treatment duration
- 37 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP11423984 · ATC
- Active substance
- Pemetrexed Disodium
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1333 mg milligram(s)
- Max total dose
- 5333 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — PEMETREXED
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129816 · ATC
- Active substance
- Paclitaxel
- Substance synonyms
- ONCOGEL, ABI-007, MBT 0206
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 533 mg milligram(s)
- Max total dose
- 2133 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1128788 · ATC
- Active substance
- Gemcitabine Hydrochloride
- Substance synonyms
- 4-AMINO-1-[(2R,4R,5R)-3,3-DIFLUORO-4-HYDROXY-5-(HYDROXYMETHYL)OXOLAN-2-YL]PYRIMIDIN-2-ONE HYDROCHLORIDE
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 2667 mg milligram(s)
- Max total dose
- 21333 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAVENOUS INFUSION
- 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
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- CDDP, Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- OTHER USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
H02AB · Product
- Pharmaceutical form
- PHF00231MIG
- Route of administration
- OTHER USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP127871 · ATC
- Active substance
- Famotidine
- Route of administration
- OTHER USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- A02BA03 — FAMOTIDINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
R06A · Product
- Pharmaceutical form
- -
- Route of administration
- OTHER USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06A — ANTIHISTAMINES FOR SYSTEMIC USE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jeffrey Thompson
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jeffrey Thompson
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Laboratory analysis |
| Almac Group Limited ORG-100011829
|
Craigavon, United Kingdom (Northern Ireland) | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| PPD Bioanalytical Laboratory ORL-000007982
|
Richmond, United States | Laboratory analysis |
Locations
5 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Ongoing, recruiting | 10 | 4 |
| Hungary | Ongoing, recruiting | 9 | 3 |
| Italy | Ongoing, recruiting | 10 | 4 |
| Poland | Ongoing, recruiting | 11 | 3 |
| Spain | Ongoing, recruiting | 7 | 1 |
| Rest of world
Turkey, Korea, Republic of, United States
|
— | 28 | — |
Investigational sites
Alexandra Hospital
Oncology-Hematology Department - Unit of Plasma Cell Dyscrasias, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Propaedeutic Internal Medicine Department, Rimini 1, 124 61, Chaidari
Metropolitan Hospital
4th Oncology Department, Ethnarchi Makariou 9, 185 47, Pireas
University General Hospital Of Heraklion
Department of Medical Oncology, Stavrakia And Voutes, 715 00, Heraklion
Orszagos Koranyi Pulmonologiai Intezet
Országos Korányi Pulmonológiai Intézet, Koranyi Frigyes Ut 1, 1121, Budapest XII
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Onkológiai Központ, Toszegi Ut 21, 5000, Szolnok
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
Dipartimento di Oncologia Medica, Via Olgettina 60, 20132, Milan
Istituto Nazionale Dei Tumori
Medical Oncology Department 1, Thoracic Oncology Unit, Via Giacomo Venezian 1, 20133, Milan
Careggi University Hospital
Radioterapia Oncologica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Uniwersyteckie Centrum Kliniczne
Centrum Wsparcia Badań Klinicznych UCK, Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
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 |
|---|---|---|---|---|---|
| Greece | 2025-07-24 | 2025-08-08 | |||
| Hungary | 2025-07-01 | 2025-08-18 | |||
| Italy | 2025-04-15 | 2025-07-02 | |||
| Poland | 2025-03-03 | 2025-03-20 | |||
| Spain | 2025-07-22 | 2025-08-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 57 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-509234-19_GRC_EL_SM05_for pub | 03R |
| Protocol (for publication) | D1_Protocol_2023-509234-19_SM05_for pub | 03R |
| Protocol (for publication) | D1_Protocol_Master U01_GRC_EL_AM03_for pub | 09R |
| Protocol (for publication) | D1_Protocol_Master_for pub | 09R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_AM01_for pub | 10JAN2025R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_GRC_EN_AM03_for pub | 06MAR2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_for pub | 25APR2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | 13MAY2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_SM06_for pub | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_GRC_EL_AM03_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_HUN_HU_SM-02_for pub | 0.00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_GRC_EL_AM03_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_HUN_HU_SM-02_for pub | 0.00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_GRC_EL_AM03_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_HUN_HU_SM-02_for pub | 0.00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_POL_PL_SM06_for pub | 12DEC2025 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent adult_GRC_EL_AM03_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ESP_ES_AM01_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_HUN_HU_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ITA_IT_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_POL_PL_SM02_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR data privacy_ITA_IT_for pub | 09MAY2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_HUN_HU_NSM01_for pub | v0-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ESP_ES_AM01_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_GRC_EL_AM03_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_HUN_HU_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ITA_IT_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_POL_PL_SM02_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent adult_GRC_EL_SM06_for pub | AM04v4.02 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM06_for pub | AM04v4.02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_SM06_for pub | AM04v3.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_NSM02_for pub | AM04_4-02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM06-RFI003_for pub | AM04v4-02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_for pub | 09MAY2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_for pub | 09MAY2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_GRC_EL_AM03_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_AM01-RFI001_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_AM01-RFI001_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_HUN_HU_for pub | 0-00R |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_HUN_HU_SM05_for pub | 3.0 |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_POL_PL_for pub | 01_00_1-3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_CARBOPLATIN_SM02_for pub | HOSPIRA UK |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_CARBOPLATIN_SM02_for pub | HOSPIRA UK |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_CARBOPLATIN_SM02_for pub | HOSPIRA UK |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_CISPLATIN_SM02_for pub | SANDOZ |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_GEMCITABINE_SM02_for pub | SUN |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_PACLITAXEL_SM02_for pub | Hospira UK |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed AUS_for pub | 23FEB2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed_for pub | Eli Lilly |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-509234-19_ESP_ES_AM01_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-509234-19_GRC_EL_AM03_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-509234-19_HUN_HU_SM-02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-509234-19_ITA_IT_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-509234-19_POL_PL_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-509234-19_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-509234-19_HUN_HU_for pub | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_MASTER_HUN_HU_for pub | 09R |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Hungary | Acceptable 2024-09-12
|
2024-09-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-08 | Hungary | Acceptable 2025-02-19
|
2025-02-21 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-04-03 | Acceptable 2025-02-19
|
2025-06-17 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-04-03 | 2025-06-30 | ||
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-04-09 | 2025-06-17 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-11 | Hungary | Acceptable | 2025-07-17 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-19 | Acceptable | 2025-06-27 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-19 | Hungary | Acceptable 2025-10-20
|
2025-10-20 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-28 | Hungary | Acceptable 2025-10-20
|
2025-10-28 |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-18 | Hungary | Acceptable 2026-03-23
|
2026-03-24 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-27 | Acceptable 2026-03-23
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2026-03-27 |