Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
375
Countries
4
Sites
19
Non-Small Cell Lung Cancer
To assess the efficacy of furmonertinib compared to platinum based chemotherapy using PFS in previously untreated patients with locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.
Key facts
- Sponsor
- Arrivent Biopharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Jun 2023 → ongoing
- Decision date (initial)
- 2023-09-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- ArriVent BioPharma, Inc., 18 Campus Blvd, Suite 100 Newtown Square, PA 19073-3269, US
External identifiers
- EU CT number
- 2022-502977-41-00
- EudraCT number
- 2022-002006-24
- ClinicalTrials.gov
- NCT05607550
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Others, Pharmacogenetic, Pharmacokinetic, Efficacy, Safety, Pharmacodynamic, Therapy
To assess the efficacy of furmonertinib compared to platinum based chemotherapy using PFS in previously untreated patients with locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.
Secondary objectives 1
- - To assess the efficacy of furmonertinib compared to platinum based chemotherapy using OS, tumor response, and progression in previously untreated patients with locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. - To assess the impact of furmonertinib compared to platinum-based chemotherapy on patients’ disease related symptoms and health related quality of life. - To evaluate the safety and tolerability of furmonertinib compared to platinum-based chemotherapy in patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. - To characterize the PK of furmonertinib and its major metabolite (AST5902).
Conditions and MedDRA coding
Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. • Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing. • No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies). • Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months. • Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
Exclusion criteria 1
- • Inability or unwillingness to swallow pills • Inability to comply with study and follow-up procedures • Any other diseases, pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications (e.g., uncontrolled hypertension, active bleeding)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS, where PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first
Secondary endpoints 3
- • OS, defined as the time from randomization to death from any cause.
- • PFS as determined by investigator assessment using RECIST v1.1.
- •Objective response rate (ORR), defined as the percentage of patients with a complete response (CR) or partial response (PR) relative to the total number of patients by BICR and investigator assessment using RECIST v1.1. For full list of secondary endpoints, please refer to protocol.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10241431 · Product
- Active substance
- N-2-2-DIMETHYLAMINOETHYL-METHYLAMINO-5-4-1-METHYLINDOL-3-YLPYRIMIDIN-2-YLAMINO-6-222-TRIFLUOROETHOXYPYRIDIN-3-YLPROP-2-ENAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ARRIVENT BIOPHARMA, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 11
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
PRD669111 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/ml milligram(s)/millilitre
- Max total dose
- 5 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- RVG 108902
- MA holder
- FRESENIUS KABI NEDERLAND B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labeling
Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung
PRD2832939 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- I.T. BOLUS INJECTION TO THE INTRATHECAL SPACE
- Max daily dose
- 5 mg/ml milligram(s)/millilitre
- Max total dose
- 5 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 86830.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labeling
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD10240124 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/ml milligram(s)/millilitre
- Max total dose
- 5 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 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
- Yes
- Modification description
- Study-specific packaging and labeling
Pemetrexed Accord 500 mg powder for concentrate for solution for infusion.
PRD3636607 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1071/002
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labeling
Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
PRD7936182 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/005
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labeling
Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion
PRD3399796 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1057/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labeling
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 USE
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 60 Month(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
- Yes
- Modification description
- Study-specific packaging and labeling
Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
PRD7936184 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/003
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labeling
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 USE
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 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
- Yes
- Modification description
- Study-specific packaging and labeling
Cisplatin Accord 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD1951578 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 76804.00.00
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labeling
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 39021.01.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labeling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arrivent Biopharma Inc.
- Sponsor organisation
- Arrivent Biopharma Inc.
- Address
- 18 Campus Boulevard Suite 100
- City
- Newtown Square
- Postcode
- 19073-3240
- Country
- United States
Scientific contact point
- Organisation
- Arrivent Biopharma Inc.
- Contact name
- Furmonertinib Study info Help Desk
Public contact point
- Organisation
- Arrivent Biopharma Inc.
- Contact name
- Furmonertinib Study info Help Desk
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Other, Laboratory analysis |
| Life Technologies Clinical Services Lab Inc. ORG-100046606
|
West Sacramento, United States | Other, Laboratory analysis |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Interactive response technologies (IRT) |
| Pharmaron (Chengdu) Clinical Services Co. Ltd. ORG-100045990
|
Chengdu, China | Code 8 |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 12, Code 2, Code 8 |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other, Laboratory analysis |
| FMD K And L Inc. ORG-100027185
|
Fort Washington, United States | Data management, E-data capture |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Code 10 |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other, Laboratory analysis |
| Catalent Germany Schorndorf GmbH ORG-100011845
|
Schorndorf, Germany | Code 14, Other |
Locations
4 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 28 | 6 |
| Italy | Ongoing, recruitment ended | 20 | 6 |
| Netherlands | Ongoing, recruitment ended | 12 | 2 |
| Spain | Ongoing, recruitment ended | 10 | 5 |
| Rest of world
Thailand, United Kingdom, Japan, China, United States, Korea, Republic of, Israel, Malaysia, Australia, Canada, Taiwan, Singapore, Mexico, Philippines, Brazil
|
— | 305 | — |
Investigational sites
Assistance Publique Hopitaux De Marseille
Oncologie Multidisciplinaire et Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Centre Francois Baclesse
N/A, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Universitaire De Toulouse
Service de Pneumologie, 24 Chemin De Pouvourville, 31400, Toulouse
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Hospices Civils De Lyon
Service de Pneumologie, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
I.F.O. Istituti Fisioterapici Ospitalieri
Medical Oncology, Via Elio Chianesi N 53, 00144, Rome
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Thoracic Oncology, Via Piero Maroncelli 40, 47014, Meldola
European Institute Of Oncology S.r.l.
Thoracic Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Research Hospital
Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Tumori Bari Giovanni Paolo II
Thoracic Diseases, Viale Orazio Flacco 65, 70124, Bari
Centro Di Riferimento Oncologico Di Aviano
Thoracic Oncology, Via Franco Gallini 2, 33081, Aviano
Ziekenhuis St Jansdal
Lung Cancer Center, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Netherlands Cancer Institute
MOD, Thoracic-Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Regional De Malaga
Oncology Service, Avenida De Carlos De Haya S/n, 29010, Malaga
Hospital Universitari Vall D Hebron
Oncology Service, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Complexo Hospitalario Universitario A Coruna
Oncology Service, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Y Politecnico La Fe
Oncology Service, Avenida De Fernando Abril Martorell 106, 46026, Valencia
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 | 2023-06-23 | 2023-06-23 | 2025-03-12 | ||
| Italy | 2023-08-29 | 2024-02-06 | 2025-03-12 | ||
| Netherlands | 2023-06-28 | 2023-10-24 | 2025-03-12 | ||
| Spain | 2023-09-13 | 2023-10-19 | 2025-03-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-08-02
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with the version 6.4 of CTR Q and A point 1.23 ; the sponsor is requested to submit a specific SM part II only in France in order to update its CTA in line with the documentation approved during the apeal procedure within 10 days after the submission of this corrective measure.
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 Addendum Number 1_2022-502977-41-00_Redacted | Add. No. 1 |
| Protocol (for publication) | D1_Protocol_2022-502977-41-00_FP | 4.0 |
| Protocol (for publication) | D2_Protocol_Clarification letter_2022-502977-41-00_FP | 7.0 |
| Protocol (for publication) | D4_Patient Facing Documents_EQ-5D-5L_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_NL | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_FACT-G Item GP5_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_FACT-G Item GP5_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_FACT-G_NL | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_NSCLC-SAQ_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_NSCLC-SAQ_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_NSCLC-SAQ_NL | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_QLQ-C30-LC13_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30-LC13_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30LC13_NL | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_24-11-23 | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_NL | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Adequacy of Means_Redacted | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | N/A |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Business card for investigators_24-11-23 | N/A |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Flyer for investigators_24-11-23 | N/A |
| Recruitment arrangements (for publication) | K2_Additional document_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Additional document_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_COVID impact_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Beyond Progression_ES | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_IT_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_NL_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES_Redacted | 5.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy_FR | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy_IT | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_IT_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_NL_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ES | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FR_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_EQ-5D-5L_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_FACT-G Item GP5_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_GP letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_IT_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ID Card_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Patient diary 160mg | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Patient diary 240mg | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_PROC_NSCLC-SAQ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_QLQ-C30-LC13_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Rationale for ethnicity collection_Redacted | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Reimbursement Procedures_IT_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Reimbursement Request Form_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Subject ID Card_Redacted | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin_Bendalis | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin_Fresenius | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin_Hikma | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin_Accord | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin_Hexal | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin_Hikma | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed_Accord | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed_Fresenius | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed_Pfizer | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502977-41-00_EN_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502977-41-00_ES_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502977-41-00_FR_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502977-41-00_IT_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502977-41-00_NL_FP | 4.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-26 | Spain | Acceptable 2023-09-04
|
2023-09-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-05 | Spain | Acceptable 2024-02-16
|
2024-02-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-19 | Spain | Acceptable 2024-05-28
|
2024-05-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-09 | Acceptable | 2024-08-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-22 | Spain | Acceptable 2025-01-15
|
2025-01-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-31 | Spain | Acceptable 2026-02-02
|
2026-02-03 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-24 | Spain | Acceptable 2026-02-02
|
2026-02-24 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-16 | Spain | Acceptable 2026-05-04
|
2026-05-05 |