Clinical trial • Phase II • Oncology
DATOPOTAMAB DERUXTECAN for Advanced non-small cell lung cancer | Non-small cell lung cancer
Phase II trial of DATOPOTAMAB DERUXTECAN for Advanced non-small cell lung cancer | Non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced non-small cell lung cancer | Non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- ADC | Small molecule | Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 05-07-2024
- First CTIS Authorization Date
- 14-08-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase II trial across 16 sites in Italy, Netherlands, Norway and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, Study is modular in design consisting of biomarker-matched and biomarker non-matched cohorts (biomarker-directed phase 2 platform study).
- Biomarker Stratified
- True, EGFR mutation status; biomarker-matched and biomarker non-matched cohorts
- Target Sample Size
- 54
Eligibility
Recruits 54 Vulnerable population selected; informed consent is obtained using subject information and informed consent forms. Subject information and informed consent forms for adults, pregnant partners and pre-screening are listed in the application documents (ICFs available in multiple languages). No specific assent/parental consent procedures for minors are described in the record..
- Vulnerable Population
- Vulnerable population selected; informed consent is obtained using subject information and informed consent forms. Subject information and informed consent forms for adults, pregnant partners and pre-screening are listed in the application documents (ICFs available in multiple languages). No specific assent/parental consent procedures for minors are described in the record.
Inclusion criteria
- {"criterion_text":"- NSCLC with the following features: (a) Locally advanced or metastatic disease (ie, advanced NSCLC) not amenable to curative surgery or radiotherapy at study entry. (b) Histologically or cytologically confirmed adenocarcinoma of the lung (patients with mixed histology are eligible if adenocarcinoma is the predominant histology) harboring EGFR mutation(s) known to be associated with EGFR TKI sensitivity at diagnosis. (c) Received only one line of therapy, with single-agent osimertinib, for advanced NSCLC, with clinical benefit as judged by investigator discretion. (Note: a ‘line’ of therapy is defined as a daily anti-cancer treatment administered for >14 days, or a single infusion of an intravenous anti-cancer treatment. For instance, patients who have had <14 days of a first- or second- generation TKI prior to osimertinib, and stopped due to adverse events, would be eligible to enter this study, see also exclusion criteria 5). Patients previously treated adjuvantly or neo-adjuvantly are eligible per exclusion criterion 5. (d) Evidence of radiological disease progression on first-line monotherapy with osimertinib 80 mg po QD."}
- {"criterion_text":"- Suitable for a mandatory biopsy defined as having an accessible tumor; by whichever modality the site uses and, ideally, confirmed by the person who will perform the procedure; and a stable clinical condition that will allow the patient to tolerate the procedure. The biopsy should be performed within 60 days of the planned first dose of study treatment."}
- {"criterion_text":"- Patients must have measurable disease per RECIST 1.1, as defined by at least 1 lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter (except lymph nodes which must have a short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI), which is suitable for accurate repeated measurements. Previously irradiated lesions or a lesion in the field of radiation should not be used as measurable disease unless the lesion(s) has/have demonstrated unequivocal disease progression by RECIST 1.1. Target lesions should not be used for the baseline tumour biopsy, unless there are no other lesions suitable for biopsy and they fulfil requirements."}
- {"criterion_text":"- Adequate coagulation parameters, defined as: International Normalisation Ratio (INR) < 1.5 × upper limit of normal (ULN) and activated partial thromboplastin time < 1.5 × ULN unless patients are receiving therapeutic anti-coagulation which affects these parameters."}
Exclusion criteria
- {"criterion_text":"- Patients whose disease has progressed within the first 3 months of osimertinib treatment (refractory to osimertinib treatment)."}
- {"criterion_text":"- Patients must not have experienced a toxicity(-ies) that led to permanent discontinuation or dose reduction of prior osimertinib. (a) Patients who had dose reductions in the past, but were receiving a full dose of osimertinib at the time of pre-screening should be discussed with the Study Physician."}
- {"criterion_text":"- Any unresolved toxicities from prior osimertinib treatment greater than CTCAE Grade 1 at the time of starting study treatment."}
- {"criterion_text":"- Patients should not have discontinued osimertinib >60 days prior to the first dose of study treatment."}
- {"criterion_text":"- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: a) Absolute neutrophil count < 1.5 × 109/L. b) Platelet count < 100 × 109/L. c) Haemoglobin < 9 g/dL. d) Alanine transaminase (ALT) > 2.5 × ULN. e) Aspartate aminotransferase (AST) > 2.5 × ULN. f) Total bilirubin (TBL) > 1.5 × ULN, or > 3 × ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinaemia)."}
- {"criterion_text":"- Creatinine clearance (CrCl) < 50 mL/min, calculated using Cockcroft-Gault equation (Cockcroft and Gault 1976) or 24-hour urine collection."}
Endpoints
Primary endpoints
- {"endpoint_text":"- To assess the efficacy of each treatment by evaluation of objective response rate - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) • Objective response rate (ORR)","definition_or_measurement_approach":"Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1); Objective response rate (ORR)"}
Secondary endpoints
- {"endpoint_text":"- To assess the efficacy of each treatment by evaluation of tumour response and overall survival Overall survival (OS) - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1): • Progression-free survival (PFS) • Duration of response (DoR)","definition_or_measurement_approach":"Tumour response and survival endpoints measured using RECIST 1.1; includes Progression-free survival (PFS), Duration of response (DoR) and Overall survival (OS)."}
- {"endpoint_text":"- To assess the pharmacokinetics (PK) of each treatment: plasma/serum concentrations will be measured.","definition_or_measurement_approach":"PK endpoints: plasma/serum concentrations of specific agents measured at selected time points."}
- {"endpoint_text":"- To assess the safety and tolerability of each treatment - • Adverse events/serious adverse events (AEs/SAEs): • Physical examinations • Laboratory findings • Vital signs • Electrocardiogram (ECG). • Left ventricular ejection fraction (LVEF)","definition_or_measurement_approach":"Safety/tolerability assessed via AEs/SAEs reporting, physical examinations, laboratory tests, vital signs, ECG and LVEF measurements."}
Recruitment
- Planned Sample Size
- 54
- Recruitment Window Months
- 10
- Consent Approach
- Informed consent obtained using subject information and informed consent forms (L1_SIS and ICF documents). ICFs available for adults and for specific modules; documents listed in multiple languages including Italian, Dutch, Spanish, Swedish, Norwegian and English. No specific information on assent or parental consent for minors is provided in the record.
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 45
Italy
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 09-12-2024
- Processing Time Days
- 111
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncology 2
- Principal Investigator Name
- Laura Bonanno
- Principal Investigator Email
- laura.bonanno@iov.veneto.it
- Contact Person Name
- Laura Bonanno
- Contact Person Email
- laura.bonanno@iov.veneto.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Oncologia
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- S.C. Oncologia Clinica Sperimentale Toraco-Polmonare
- Principal Investigator Name
- Alessandro Morabito
- Principal Investigator Email
- a.morabito@istitutotumori.na.it
- Contact Person Name
- Alessandro Morabito
- Contact Person Email
- a.morabito@istitutotumori.na.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 17-01-2025
- Processing Time Days
- 156
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- longziekten
- Principal Investigator Name
- Lizza Hendriks
- Principal Investigator Email
- lizza.hendriks@mumc.nl
- Contact Person Name
- Lizza Hendriks
- Contact Person Email
- lizza.hendriks@mumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Afdeling Oncologie
- Principal Investigator Name
- Marthe Paats
- Principal Investigator Email
- m.paats@erasmusmc.nl
- Contact Person Name
- Marthe Paats
- Contact Person Email
- m.paats@erasmusmc.nl
- Site Name
- Stichting Amsterdam UMC
- Department Name
- Afdeling Medische Oncologie
- Principal Investigator Name
- Sayed Hashemi
- Principal Investigator Email
- s.hashemi@vumc.nl
- Contact Person Name
- Sayed Hashemi
- Contact Person Email
- s.hashemi@vumc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Thoraxoncologie
- Principal Investigator Name
- Adrianus Johannes de Langen
- Principal Investigator Email
- j.d.langen@nki.nl
- Contact Person Name
- Adrianus Johannes de Langen
- Contact Person Email
- j.d.langen@nki.nl
Norway
- Earliest CTIS Part Ii Submission Date
- 15-08-2024
- Latest Decision Or Authorization Date
- 20-12-2024
- Processing Time Days
- 127
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- St. Olavs Hospital HF
- Department Name
- Onkologisk avdeling
- Principal Investigator Name
- Bjørn Grønberg
- Principal Investigator Email
- Bjorn.Gronberg@stolav.no
- Contact Person Name
- Bjørn Grønberg
- Contact Person Email
- Bjorn.Gronberg@stolav.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Onkologisk avdeling
- Principal Investigator Name
- Knut Smeland
- Principal Investigator Email
- knusme@ous-hf.no
- Contact Person Name
- Knut Smeland
- Contact Person Email
- knusme@ous-hf.no
- Site Name
- Vestre Viken HF
- Department Name
- Onkologisk avdeling
- Principal Investigator Name
- Odd Terje Brustugun
- Principal Investigator Email
- OTR@vestreviken.no
- Contact Person Name
- Odd Terje Brustugun
- Contact Person Email
- OTR@vestreviken.no
Sweden
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 05-12-2024
- Processing Time Days
- 113
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Cancerstudieenheten
- Principal Investigator Name
- Simon Ekman
- Principal Investigator Email
- simon.ekman@ki.se
- Contact Person Name
- Simon Ekman
- Contact Person Email
- simon.ekman@ki.se
Spain
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 05-12-2024
- Processing Time Days
- 113
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncología
- Principal Investigator Name
- Javier de Castro
- Principal Investigator Email
- javier.decastro@salud.madrid.org
- Contact Person Name
- Javier de Castro
- Contact Person Email
- javier.decastro@salud.madrid.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncología
- Principal Investigator Name
- Rosario García Campelo
- Principal Investigator Email
- MA.Rosario.Garcia.Campelo@sergas.es
- Contact Person Name
- Rosario García Campelo
- Contact Person Email
- MA.Rosario.Garcia.Campelo@sergas.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología
- Principal Investigator Name
- Santiago Ponce
- Principal Investigator Email
- sponceaix@gmail.com
- Contact Person Name
- Santiago Ponce
- Contact Person Email
- sponceaix@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncología
- Principal Investigator Name
- Noemí Reguart
- Principal Investigator Email
- nreguart@clinic.cat
- Contact Person Name
- Noemí Reguart
- Contact Person Email
- nreguart@clinic.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncología
- Principal Investigator Name
- Margarita Majem
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Margarita Majem
- Contact Person Email
- mmajem@santpau.cat
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Datopotamab deruxtecan
- Active Substance
- DATOPOTAMAB DERUXTECAN
- Modality
- ADC
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- PRD9684738
- Maximum Dose
- 6 mg/Kg (max daily dose amount 6 mg/Kg as listed)
- Investigational Product Name
- TAGRISSO 80 mg film-coated tablets
- Active Substance
- OSIMERTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- EU/1/16/1086/004
- Starting Dose
- 80 mg po QD
- Frequency
- Once daily (QD) as per product description/inclusion criteria
- Maximum Dose
- 80 mg
- Investigational Product Name
- TAGRISSO 40 mg film-coated tablets
- Active Substance
- OSIMERTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- EU/1/16/1086/003
- Maximum Dose
- 80 mg (product max daily dose listed 80 mg)
- Investigational Product Name
- Koselugo 25 mg hard capsules
- Active Substance
- SELUMETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- EU/1/21/1552/002
- Orphan Designation
- Yes
- Maximum Dose
- 150 mg
- Investigational Product Name
- IMFINZI 50 mg/mL concentrate for solution for infusion.
- Active Substance
- DURVALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- EU/1/18/1322/001
- Maximum Dose
- 1500 mg/m2 (max daily dose amount listed 1500 mg/m2)
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- SUB07483MIG
- Maximum Dose
- 80 mg/m2 (max daily dose amount listed 80 mg/m2; max total dose amount 300 mg)
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- SUB07337MIG
- Maximum Dose
- 100 mg/m2
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- SUB06614MIG
- Maximum Dose
- 750 mg/m2
- Investigational Product Name
- Inflectra 100 mg powder for concentrate for solution for infusion
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- EU/1/13/854 (multiple PRD numbers listed)
- Investigational Product Name
- Mycophenolate Mofetil Accord 250 mg capsules
- Active Substance
- MYCOPHENOLATE MOFETIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- PA 2315/064/001
- Combination Treatment
- Yes
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