Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
606
Countries
6
Sites
30
Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
The primary objective of this study is to demonstrate the therapeutic equivalence of CT-P51 and Keytruda in terms of ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the intent-to-treat(ITT) set.
Key facts
- Sponsor
- Celltrion Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jan 2025 → ongoing
- Decision date (initial)
- 2024-12-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Celltrion, Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Bioequivalence, Pharmacokinetic, Safety
The primary objective of this study is to demonstrate the therapeutic equivalence of CT-P51 and Keytruda in terms of ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the intent-to-treat(ITT) set.
Secondary objectives 4
- The secondary efficacy objective of this study is to evaluate additional efficacy profiles of CT-P51, and EU-Keytruda in terms of ORR based on the confirmed BOR during the Main Treatment Period and the whole study period and time-to-event analysis during the Main Treatment Period and the whole study Period.
- The secondary immunogenicity objective of this study is to evaluate immunogenicity profiles in terms of incidence and titer levels of anti-pembrolizumab antibody and incidence of neutralizing antibody.
- The secondary safety objective of this study is to evaluate safety profiles in terms of occurrence and severity of TEAEs and descriptive characterization of lab parameters and other safety evaluation.
- The secondary PK objective of this study is to evaluate the PK profile in terms of Ctrough at each cycle with serum samples collected for PK analyses.
Conditions and MedDRA coding
Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Main Treatment Period CT-P51 or Keytruda 200mg with pemetrexed and cisplatin or carboplatin will be administered every 3 weeks for a maximum of 4 cycles followed by CT-P51 or Keytruda and pemetrexed every 3 weeks up to total 18 cycles until unacceptable toxicity, PD, or maximum of 18 cycles, whichever occurs first.
|
Randomised Controlled | Double | [{"id":110039,"code":2,"name":"Investigator"},{"id":110041,"code":1,"name":"Subject"},{"id":110037,"code":5,"name":"Carer"},{"id":110040,"code":3,"name":"Monitor"},{"id":110038,"code":4,"name":"Analyst"}] | CT-P51: 200 mg IV Q3W until unacceptable toxicity, PD, or a maximum of 18 cycles, whichever occurs first. EU-approved Keytruda: 200 mg IV Q3W until unacceptable toxicity, PD, or a maximum of 18 cycles, whichever occurs first. |
| 2 | Extenstion Treatment Period Patients who completed Main Treatment Period can continued to benefit from treatment without PD or intolerable toxicity can continue to receive CT-P51 at the discretion of the investigator until unacceptable toxicity, PD, up to an addtional 17 cycles, or 2 years from randomization, whichever occurs first.
|
Randomised Controlled | None | CT-P51: 200 mg IV Q3W until unacceptable toxicity, PD, up to addtional 17 cycles, or 2 years from randomization, whichever occurs first |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Male or female ≥ 18 years
- Stage IV, non squamous NSCLC
- Patient with negative result in both EGFR mutation and ALK rearrangement. Patients already known to have ROS1 rearrangement, MET exon 14 skipping, RET rearrangement, or BRAF V600E mutation will be excluded if ROS1, MET, RET, or BRAF-directed therapy is indicated by local guidelines
- Have a tumor sample not irradiated prior to biopsy that is adequate for PD-L1 assessment by immunohistochemistry (IHC) assay and obtained within 6 months prior to randomization
- Have not received prior systemic anticancer therapy for metastatic nsNSCLC (Prior adjuvant/neoadjuvant NSCLC therapy is permitted if completed at least 12 months prior to the development of metastatic disease.)
- Have at least 1 measurable lesion per RECIST version 1.1 (Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.) a) Tumor lesions: ≥ 10 mm in long axis by CT scan b) Malignant lymph nodes: ≥ 15 mm in short axis by CT scan
- Have a ECOG Performance score of ≤ 1, Life expectancy of at least 3 months
- Have adequate organ function
Exclusion criteria 9
- Have predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible
- Have carcinomatous meningitis or active CNS metastases. (Note: Patients with previously treated brain metastases at least 2 weeks prior to the first study drug administration and without suspicion of further CNS progression may participate.)
- Have clinically significant third-space fluid; for example, ascites or pleural effusion that cannot be controlled by drainage or other procedures prior to the first dose
- Had prior treatment with one or more of followings: a) anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathway b) any systemic anticancer therapy for metastatic disease c) major surgery (<3 weeks prior to the first dose) d) palliative radiotherapy for non-CNS metastases (<1 week prior to the first dose) e) radiotherapy to the lung that is of > 30 Gy (<6 months prior to the first dose)
- Have known history of malignancy other than NSCLC in the past 5 years except adequately treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Is expected to require chronic systemic steroids
- Have an active infection requiring systemic therapy (<2 weeks prior to the first dose)
- Have interstitial lung disease or a history of pneumonitis that required steroids
- Unable or unwilling to take folic acid or vitamin B12 supplementation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11041591 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 7000 mg milligram(s)
- Max treatment duration
- 106 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELLTRION INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
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
- INTRAVENIOUS INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 55 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
Auxiliary 7
Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD9682731 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 13 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 2205259.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
PRD7936183 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 17500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 106 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/004
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD2433136 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 17500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 106 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD2433114 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 17500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 106 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD2433080 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 17500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 106 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD291536 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 17500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 106 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD10240125 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 13 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 3002152.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celltrion Inc.
- Sponsor organisation
- Celltrion Inc.
- Address
- 23 Academy-Ro, Yeonsu-Gu Yeonsu-Gu
- City
- Incheon
- Postcode
- 22014
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Celltrion Inc.
- Contact name
- Clinical Planning
Public contact point
- Organisation
- Celltrion Inc.
- Contact name
- JaeYoung Jang
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Syneos Health Romania S.R.L. ORG-100051180
|
Bucharest, Romania | On site monitoring, Other |
| Syneos Health Hellas Single Member S.A. ORG-100043210
|
Vrilissia, Greece | On site monitoring, Other |
Locations
6 EU/EEA countries · 30 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Authorised, recruitment pending | 30 | 2 |
| Greece | Authorised, recruitment pending | 20 | 3 |
| Lithuania | Authorised, recruitment pending | 30 | 2 |
| Poland | Authorised, recruitment pending | 60 | 10 |
| Romania | Authorised, recruitment pending | 20 | 4 |
| Spain | Ongoing, recruiting | 50 | 9 |
| Rest of world
Vietnam, Argentina, Chile, Georgia, Ukraine, Bosnia and Herzegovina, Malaysia, Taiwan, Mexico, Brazil, Serbia, North Macedonia, India, Turkey, Thailand, Peru, Korea, Republic of
|
— | 396 | — |
Investigational sites
Pula General Hospital Ospedale Generale di Pola
Department of Internal Oncology and Hematology, Santoriova Ulica 24a, Pula, Pula - Pola
Klinicki bolnicki centar Sestre milosrdnice
Department of Oncology and Nuclear Medicine, Vinogradska Cesta 29, Zagreb, Grad Zagreb
Theageneio Cancer Hospital
3rd Department of Clinical Oncology, Simeonidi Alex 2, 546 39, Thessaloniki
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
7th Oncology Clinic, Leoforos Mesogeion 264, 155 62, Cholargos
Thoracic General Hospital Of Athens I Sotiria
3rd Departments of Internal Medicine, Messogion Avenue 152, 115 27, Athens
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department of Pulmonology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Nacionalinis vezio institutas
N/A, Santariskiu G. 1, Vilniaus M. Sav., Vilnius
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddzial Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
NA Oddział Onkologii z Pododdziałem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Kliniczny Oddzial Pneumonologii, Alergologii, Onkologii Pulmonologicznej i Chorob Wewnetrznych, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
NA, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Oddział Onkologiczny - Centrum Kompetencji Raka Piersi, Centrum Kompetencji Raka Jelita Grubego, Ul. Alfreda Sokolowskiego 4, 58-309, Walbrzych
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Oddział Pulmonologii, Ul. Kuracyjna 30, 82-550, Prabuty
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclaw
Oddział Onkologii Klinicznej, ul. Rudolfa Weigla 5, 50-981, Wrocław
dr hab.n.med. Sławomir Mandziuk Specjalistyczna Praktyka Lekarska
NA, Chodzki 17/2, 20-093, Lublin
Oncolab S.R.L.
Specialitatea Oncologie Medicala, Strada Bujorului 7, 200385, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie, Strada Republicii 34-36, 400015, Cluj-Napoca
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Generala si Chimioterapie, Strada Republicii 34-36, 400015, Cluj-Napoca
Oncomed S.R.L.
Specialitatea Oncologie Medicala, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Hospital La Milagrosa S.A.
Oncology, Calle Modesto Lafuente 14, 28010, Madrid
Hospital Universitario De Torrejon
Oncology, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital De Jerez De La Frontera
Oncology, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinico San Carlos
Medical Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Spain | 2025-01-30 | 2025-02-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 64 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514048-98_GR_public | 2.0 |
| Protocol (for publication) | D1_Protocol_2024-514048-98_public | 2.0 |
| Protocol (for publication) | D1_Protocol_2024-514048-98_public_track | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_GR | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_LT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_SPA_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biomarker Testing_GR_redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Pregnant Partner_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_GR | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_GR_redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Pregnant Subject_HRV_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Pregnant Subjects Partner_HRV_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_HRV_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_LIT_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RO_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RUS_CoT_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RUS_OTR_Redacted | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RUS_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Testing_EN_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Testing_HRV_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Testing_LIT_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Testing_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Testing_RO_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Testing_RUS_CoT_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Testing_RUS_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and Pregnant Partner_EN_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and Pregnant Partner_LIT_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and Pregnant Partner_RO_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and Pregnant Partner_RUS_CoT_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and Pregnant Partner_RUS_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information materials_Participant Card ID_RO_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject_ID_Card_HR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject_ID_Card_LIT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject_ID_Card_RUS_CoT_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject_ID_Card_RUS_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Participant Card ID_EN_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_PatientGO Consent Form_EN_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_PatientGO Consent Form_RO_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_PatientGO Patient Info Sheet_EN_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_PatientGO Patient Info Sheet_RO_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Payment Card Letter_EN_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Payment Card Letter_RO_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Reimbursement Payment Details Form_EN_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Reimbursement Payment Details Form_RO_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Reimbursement Policy_EN_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Reimbursement Policy_RO_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Pregnancy and Pregnant Partner_SPA_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L3_SIS and ICF Optional Biomarker_SPA_Redacted | 1.2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_EU Keytruda | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-514048-98_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-514048-98_public_track | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-514048-98_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR_2024-514048-98_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HR_2024-514048-98_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_LT_2024-514048-98_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2024-514048-98_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2024-514048-98_public | 2.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-22 | Lithuania | Acceptable 2024-12-11
|
2024-12-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-14 | Acceptable | 2025-04-22 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-18 | Acceptable | 2025-03-31 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-20 | Acceptable | 2025-03-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-26 |