Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
677
Countries
7
Sites
50
Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer
- To assess the antitumour activity of neoadjuvant treatment administered prior to surgery in terms of pCR - To assess the safety and tolerability of neoadjuvant and adjuvant treatment
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Jun 2022 → ongoing
- Decision date (initial)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2023-508852-21-00
- EudraCT number
- 2021-003369-37
- WHO UTN
- U1111-1307-4238
- ClinicalTrials.gov
- NCT05061550
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacogenomic, Therapy, Efficacy, Safety, Pharmacogenetic
- To assess the antitumour activity of neoadjuvant treatment administered prior to surgery in terms of pCR
- To assess the safety and tolerability of neoadjuvant and adjuvant treatment
Secondary objectives 9
- To assess the efficacy of neoadjuvant treatment administered prior to surgery followed by adjuvant treatment post-surgery in terms of EFS and DFS
- To assess the feasibility of receiving the planned surgical tumour resection in patients receiving neoadjuvant treatment
- To assess the antitumour activity of neoadjuvant treatment administered prior surgery in terms of mPR
- To assess the efficacy of neoadjuvant treatment administered prior to surgery in terms of ORR
- To assess the efficacy of neoadjuvant and adjuvant treatment in terms of OS
- To describe the PK of study drugs in patients receiving neoadjuvant/adjuvant treatment
- To assess the immunogenicity of study drugs in patients receiving neoadjuvant/adjuvant treatment
- To investigate baseline PD-L1 expression in patients treated with neoadjuvant and adjuvant treatment, and associations with clinical endpoints
- To evaluate changes in ctDNA during neoadjuvant treatment in patients with evaluable ctDNA and associations with clinical endpoints
Conditions and MedDRA coding
Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10029519 | Non-small cell lung cancer stage III | 100000004864 |
| 21.1 | PT | 10029521 | Non-small cell lung cancer stage IIIB | 100000004864 |
| 21.1 | PT | 10029520 | Non-small cell lung cancer stage IIIA | 100000004864 |
| 21.1 | PT | 10029518 | Non-small cell lung cancer stage II | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
- WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.
- Adequate pulmonary function.
Exclusion criteria 17
- Patients with: (a) sensitising EGFR mutations or ALK translocations.; (b) with baseline PD-L1 expression status < 1% (Arms 6 and 7 only);(i) Note: PD-L1 expression status < 1% only applies as an exclusion when Arms 6 or 7 are open to enrolment
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
- History of another primary malignancy.
- Participants with small-cell lung cancer or mixed small-cell lung cancer.
- History of active primary immunodeficiency.
- History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Participants who have preoperative radiotherapy treatment as part of their care plan.
- Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
- QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
- Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
- Participants with moderate or severe cardiovascular disease.
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
- Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
- Active or uncontrolled infections including HBA, HBV, HCV, and HIV.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- pCR is defined as lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes as determined by central BIPR and described by IASLC 2020. The measure of interest is the proportion of patients with 0% residual viable tumour cells within all resected tissue as assessed by the central blinded pathologist.
- Safety and tolerability will be evaluated in terms of AEs, vital signs, and clinical laboratory parameters.
Secondary endpoints 10
- EFS is defined as the time from randomisation to the first of the following: local or distant disease recurrence, progressive disease that precludes surgery or prevents completion of surgery, or death due to any cause.
- DFS is defined as the time from surgery until the first of the following: local or distant disease recurrence or date of death due to any cause.
- Feasibility to surgery is defined as having the planned surgical resection within 40 days from the end of the last dose of neoadjuvant study interventions. The measure of interest is the proportion of patients that have intended surgery within 40 days from the end of last dose of neoadjuvant study interventions.
- mPR is defined as ≤ 10% viable tumour cells in resected tumour after complete evaluation in the resected lung cancer specimen as determined by central BIPR as described by IASLC 2020. The measure of interest is the proportion of patients with ≤ 10% residual viable tumour cells within all resected tissue as assessed by the central blinded pathologist.
- ORR is defined as the proportion of patients who have a CR or PR as determined by Investigator using RECIST 1.1. Patients who go off therapy prior to surgery, without a response, receive a subsequent therapy prior to surgery, and then respond will not be included as responders in the ORR. The measure of interest is the proportion of patients with OR.
- OS is defined as the time from randomisation until the date of death due to any cause. The measure of interest is the landmark OS at 12 months and 24 months, and other clinically relevant timepoints if feasible. If reached by the end of the study, the median OS will also be of interest.
- Concentration of study interventions in plasma or serum.
- Presence of ADA for study interventions.
- Baseline PD-L1 expression.
- ctDNA clearance on-treatment prior to surgery.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
SCP11423984 · ATC
- Active substance
- Pemetrexed Disodium
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — PEMETREXED
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11164893 · Product
- Active substance
- Oleclumab
- Substance synonyms
- MEDI9447
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- 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 USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9684738 · Product
- Active substance
- Datopotamab Deruxtecan
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/Kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- DAIICHI SANKYO, INC.
- Paediatric formulation
- No
- Orphan designation
- No
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10970031 · Product
- Active substance
- Monalizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10448215 · Product
- Active substance
- Rilvegostomig
- Substance synonyms
- AZD 2936, Bispecific IgG1 monoclonal antibody against PDCD1 and TIGIT
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD11287675 · Product
- Active substance
- Falbikitug
- Substance synonyms
- Humanised IgG1 kappa monoclonal antibody against LIF interleukin 6 family cytokine, AZD-0171
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10191166 · Product
- Active substance
- Volrustomig
- Substance synonyms
- MEDI5752, Human IgG1 monoclonal antibody with an engineered Fc domain targeting PD-1 and CTLA-4
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 6
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6487529 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/005
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6483619 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6487527 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6487528 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/004
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6483369 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
Mycophenolate Mofetil 250 mg Capsules
PRD391889 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- PL20075/0097
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 2, Code 5, Data management, Code 8, Code 9 |
Locations
7 EU/EEA countries · 50 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 8 | 5 |
| France | Ongoing, recruiting | 153 | 7 |
| Hungary | Ongoing, recruiting | 33 | 4 |
| Ireland | Ongoing, recruiting | 9 | 4 |
| Italy | Ongoing, recruiting | 144 | 12 |
| Portugal | Ongoing, recruiting | 40 | 5 |
| Spain | Ongoing, recruiting | 106 | 13 |
| Rest of world
Korea, Republic of, Turkey, Taiwan, United States, Canada
|
— | 184 | — |
Investigational sites
Algemeen Ziekenhuis Delta
0503: Department of Pulmonary Disease, Deltalaan 1, 8800, Roeselare
UZ Leuven
0501: Pneumologie, Herestraat 49, 3000, Leuven
AZ Sint-Lucas & Volkskliniek
0504: longziekten, Groenebriel 1, 9000, Gent
Az Maria Middelares Gent
0505: Pneumologie, Buitenring-Sint-Denijs 30, 9000, Gent
Grand Hopital De Charleroi
0502: Oncologie - Hématologie, Rue Du Campus Des Viviers 1, 6060, Charleroi
Centre Hospitalier Universitaire De Bordeaux
2401:Service d'Oncologie Medicale, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Hospitalier Universitaire Rouen
2405:Service de pneumologie, oncologie thoracique et soins intensifs respiratoires, 1 Rue De Germont, Bp 96031, Rouen Cedex
Hospital Foch
2404:Service d'Oncologie Medicale, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Intercommunal De Cornouaille
2402:Service de Pneumologie, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
HIA Sainte Anne
2406:Service de Pneumologie, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Centre Hospitalier Et Universitaire De Limoges
2403:Service de Pneumologie, Oncologie Thoracique et Pneumologie Interventionnelle, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier D Avignon
2407:Service Onco-Hématologie, 305 Rue Raoul Follereau, 84000, Avignon
Bacs-Kiskun Varmegyei Oktatokorhaz
3301:Onkoradiológiai Központ, Nyiri Ut 38, 6000, Kecskemet
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
3303:Pulmonológiai Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Reformatus Pulmonologiai Centrum
3302:Onkológia, kúra - fekvőbeteg ellátás, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
3304:Tüdőgyógyászati Osztály, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Beaumont Hospital
3904:Oncology, Beaumont Road, Beaumont, Dublin 9
St James's Hospital
3903:Haematology Oncology Daycare (HODC) Metabolic Research Unit, James's Street, D08 NHY1, Dublin 8
Mater Misericordiae University Hospital
3902:Clinical Trials Research Unit, Eccles Street, D07 R2WY, Dublin 7
University Hospital Galway
3901:Oncology, Newcastle Road, H91 YR71, Galway
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
4108:Dipartimento di Oncologia ed Ematologia clinica e sperimentale, Via Piero Maroncelli 40, 47014, Meldola
Fondazione IRCCS San Gerardo Dei Tintori
4102:SC Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
ASST Grande Ospedale Metropolitano Niguarda
4112:Dipartimento di Ematologia ed Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
4113:UO Oncologia Medica, Piazzale Spedali Civili 1, 25123, Brescia
Humanitas Mirasole S.p.A.
4104:UO Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
I.F.O. Istituti Fisioterapici Ospitalieri
4101:UOC Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
University Hospital Of Perugia
4106:SC Oncologia Medica, Via Gerardo Dottori 1, 06132, Perugia
Centro Di Riferimento Oncologico Di Aviano
4103:Dipartimento Oncologia medica, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliero Universitaria Pisana
4109:Dipartimento Cardiotoraco vascolare, Via Paradisa 2, 56124, Pisa
Careggi University Hospital
4110:UO Radioterapia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Ospedale Policlinico San Martino
4107:UO Clinica di Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Oncologico Veneto
4105:Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Unidade Local De Saude De Sao Jose E.P.E.
5804:Oncologia, Rua Jose Antonio Serrano, 1150-199, Lisbon
Hospital Da Luz S.A.
5803:Oncologia, Avenida Lusiada 100, 1500-650, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
5805:Oncologia Medica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
5807:Serviço de Pneumologia, Rua Professor Lima Basto, 1099-023, Lisbon
Champalimaud Clinical Centre
5801:Oncologia, Avenida Brasilia S/n, 1400-038, Lisbon
Hospital Universitario Puerta De Hierro De Majadahonda
7002:Oncologia, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario Virgen De La Macarena
7008:Oncología Médica, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Fundacion Jimenez Diaz
7012:Oncología Médica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
7011:Oncología Médica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Regional De Malaga
7009:Neumología, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitari Vall D Hebron
7010:Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Reina Sofia
7007:Oncología Médica, Avenida Menendez Pidal S/n, 14004, Cordoba
Complexo Hospitalario Universitario A Coruna
7001:Oncología Médica, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Clinico San Carlos
7005:Oncología Médica, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Clinico Universitario De Valencia
7006:Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Fundacio Assistencial De Mutua De Terrassa Fpc
7003:Oncologia, Calle De San Antonio No 32, 08221, Terrassa
Hospital General Universitario Dr. Balmis
7013:Oncología, Avinguda Del Pintor Baeza 12, 03010, Alicante
Salut Sant Joan De Reus
7004:Oncología, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
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 | 2023-10-27 | 2023-10-27 | |||
| France | 2022-07-28 | 2022-07-28 | |||
| Hungary | 2023-08-04 | 2023-08-04 | |||
| Ireland | 2023-10-05 | 2023-10-05 | |||
| Italy | 2022-12-09 | 2022-12-09 | |||
| Portugal | 2022-11-16 | 2022-11-16 | |||
| Spain | 2022-06-10 | 2022-06-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 92 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Main English D9077C00001 Public | 8.0 |
| Recruitment arrangements (for publication) | K1_BEL Recruitment Procedure Description English D9077C00001 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Procedure Description English D9077C00001 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_FRA Recruitment Procedure Description D9077C00001 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_HUN Recruitment Brochure Hungarian D9077C00001 Public | 6.0 |
| Recruitment arrangements (for publication) | K1_HUN Recruitment Factsheet Hungarian D9077C00001 Public | 6.0 |
| Recruitment arrangements (for publication) | K1_HUN Recruitment Flip Chart Hungarian D9077C00001 Public | 6.0 |
| Recruitment arrangements (for publication) | K1_HUN Recruitment Poster Hungarian D9077C00001 Public | 6.0 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Flip Chart English D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Information Brochure English D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Patient Factsheet English D9077C00001 Public | 5.1 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Poster English D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K1_ITA Recruitment Procedure Description English D9077C00001 Public | 1.1 |
| Recruitment arrangements (for publication) | K1_PRT Recruitment Brochure Portuguese D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K1_PRT Recruitment Procedure Description ICF Procedure English D9077C00001 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Brochure Dutch D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Brochure French D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Other Flip Chart Dutch D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Other Flip Chart French D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Other Patient Factsheet Dutch D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Other Patient Factsheet French D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Poster Dutch D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Poster French D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Brochure Spanish D9077C00001 Public | 6.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Other Flip Chart Spanish D9077C00001 Public | 6.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Other Patient Factsheet Spanish D9077C00001 Public | 6.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Poster Spanish D9077C00001 Public | 6.0 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Brochure French D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Other Flip chart French D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Other Patient Factsheet French D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Poster French D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_ITA Recruitment Brochure Italian D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_ITA Recruitment Disease Fact Sheet Italian D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_ITA Recruitment Other Flip Chart Italian D9077C00001 Public | 5.0 |
| Recruitment arrangements (for publication) | K2_ITA Recruitment Poster Italian D9077C00001 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ FRA Country ICF Other Pregnant Partner French _D9077C00001 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Adult Dutch D9077C00001 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Adult English D9077C00001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Adult French D9077C00001 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Other Pregnant Partner Dutch D9077C00001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Other Pregnant Partner English D9077C00001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Other Pregnant Partner French D9077C00001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Addendum Spanish D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish D9077C00001 Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish D9077C00001_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish TC D9077C00001 | 8.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Other Pregnant Partner ICF Spanish D9077C00001_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Research Spanish Optional Future Research D9077C00001_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Research Spanish Optional Research D9077C00001_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main Adult French D9077C00001 Public | 8 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Research Adult French _D9077C00001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Adult Hungarian D9077C00001_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Adult SIS Hungarian D9077C00001 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Other Adult Pregnant Partner ICF Hungarian D9077C00001_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Other Adult Pregnant Partner IS Hungarian D9077C00001_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HUN Main ICF Hungarian D9077C00001 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_HUN Optional Research ICF Hungarian D9077C00001 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_HUN Optional Research SIS Hungarian D9077C00001 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_HUN Pregnant Partner ICF Hungarian D9077C00001 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_HUN Subject Participation Card English D9077C00001_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Subject Participation Card Hungarian D9077C00001_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IRL Country ICF Main English D9077C00001 Public | 7.1 |
| Subject information and informed consent form (for publication) | L1_IRL Country ICF Other Pregnant Partner English D9077C00001 Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_IRL Recruitment and Informed Consent Procedure combined English D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Adult Italian D9077C00001 Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Pregnant Partner Italian D9077C00001 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Research Italian D9077C00001 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country IRB-IEC Additional-Amendment Approval 1 Italian D9077C00001 Public | NA |
| Subject information and informed consent form (for publication) | L1_ITA Country IRB-IEC Additional-Amendment Approval 2 Italian D9077C00001 Public | NA |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Main Portuguese D9077C00001 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Other Pregnant Partner Portuguese D9077C00001 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Research Portuguese D9077C00001 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_PRT Subject Materials Other Dental Leaflet Portuguese D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BEL Subject Materials Description Other Dutch D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BEL Subject Materials Description Other French D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_ESP Subject Materials Other Dental Leaflet Spanish D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_FRA Subject Materials Other Oral kit leaflet not dated French D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_HUN Leaflet Hungarian D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_IRL Oral Care Kit leaflet D9077C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_ITA Subject Materials Other leaflet_dental Italian D9077C00001 Public | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin D9077C00001 Public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin D9077C00001 Public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel D9077C00001 Public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pemetrexed D9077C00001 Public | NA |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Dutch D9077C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main English D9077C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main French D9077C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main German D9077C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Hungarian D9077C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Italian D9077C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Portuguese D9077C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Spanish D9077C00001 Public | 1.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-29 | Portugal | Acceptable 2024-09-30
|
2024-10-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Portugal | Acceptable 2025-03-10
|
2025-03-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-19 | Portugal | Acceptable 2025-07-07
|
2025-07-07 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-01 | Portugal | Acceptable 2025-07-07
|
2025-08-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-22 | Portugal | Acceptable 2026-04-13
|
2026-04-13 |