Clinical trial • Phase III • Oncology
SACITUZUMAB TIRUMOTECAN for Non-small cell lung cancer | Nonsquamous non-small cell lung cancer
Phase III trial of SACITUZUMAB TIRUMOTECAN for Non-small cell lung cancer | Nonsquamous non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Nonsquamous non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- ADC | Small molecule
Key dates
- Initial CTIS Submission Date
- 27-09-2023
- First CTIS Authorization Date
- 06-02-2024
Trial design
Randomised, open-label, docetaxel (anhydrous docetaxel) iv; maximum indicated dose 75 mg/m2 (intravenous infusion) and pemetrexed iv; maximum indicated dose 500 mg/m2 (intravenous infusion). supportive/auxiliary medications listed (e.g., dexamethasone, antihistamines, h2-antagonists, paracetamol combinations) per trial documents.-controlled Phase III trial in Germany, Czechia, Greece and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Docetaxel (anhydrous docetaxel) IV; maximum indicated dose 75 mg/m2 (intravenous infusion) and Pemetrexed IV; maximum indicated dose 500 mg/m2 (intravenous infusion). Supportive/auxiliary medications listed (e.g., dexamethasone, antihistamines, H2-antagonists, paracetamol combinations) per trial documents.
- Biomarker Stratified
- True, biomarker: EGFR mutation status (EGFR mutations vs other genomic alterations)
- Target Sample Size
- 455
Eligibility
Recruits 455 The record indicates vulnerable population selection (isVulnerablePopulationSelected = true). Informed consent is documented via country-specific L1_ICF_Main consent documents (available for DEU, CZE, GRC, FRA, ITA, POL, ESP, etc.). Consent is provided by the adult participant (minimum age requirement: At least 18 years). No assent procedures for minors are described in the available material..
- Vulnerable Population
- The record indicates vulnerable population selection (isVulnerablePopulationSelected = true). Informed consent is documented via country-specific L1_ICF_Main consent documents (available for DEU, CZE, GRC, FRA, ITA, POL, ESP, etc.). Consent is provided by the adult participant (minimum age requirement: At least 18 years). No assent procedures for minors are described in the available material.
Inclusion criteria
- {"criterion_text":"- Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations\n- Have an ECOG performance status of 0 or 1 within 3 days before randomization\n- Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1\n- Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI\n- At least 18 years of age at the time of providing informed consent\n- Measurable disease per RECIST 1.1 as assessed by the local site investigator\n- Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided\n- Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline\n- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization\n- HIV-infected participants must have well controlled HIV on ART"}
Exclusion criteria
- {"criterion_text":"- Has predominantly squamous cell histology NSCLC\n- Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids\n- Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention\n- Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC)\n- Received prior treatment with a topoisomerase I-containing ADC\n- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n- Known additional malignancy that is progressing or has required active treatment within the past 3 years\n- Active infection requiring systemic therapy\n- History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD\n- Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization.\n- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Has mixed tumor(s) with small cell elements\n- Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection\n- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n- Has Grade ≥2 peripheral neuropathy\n- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n- Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib)\n- Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free Survival (PFS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) mutations","definition_or_measurement_approach":"PFS measured per RECIST 1.1 as assessed by blinded independent central review (BICR) (as specified in main objectives)."}
- {"endpoint_text":"- Overall Survival (OS) of Participants with NSCLC with EGFR mutations","definition_or_measurement_approach":"Overall survival measured as time to death from any cause (OS); standard survival follow-up (definition not further specified in the available extract)."}
Secondary endpoints
- {"endpoint_text":"- PFS of All Participants with NSCLC","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by BICR in all participants with NSCLC."}
- {"endpoint_text":"- OS of All Participants with NSCLC","definition_or_measurement_approach":"Overall survival (OS) in all participants with NSCLC (time to death)."}
- {"endpoint_text":"- Objective Response Rate (ORR) of Participants with NSCLC with EGFR mutations","definition_or_measurement_approach":"ORR assessed per RECIST 1.1 based on BICR."}
- {"endpoint_text":"- ORR of All Participants with NSCLC","definition_or_measurement_approach":"ORR per RECIST 1.1 (methodology: BICR for assessments as specified)."}
- {"endpoint_text":"- Duration of Response (DOR) of All Participants with NSCLC","definition_or_measurement_approach":"DOR (definition not further specified in the extract)."}
- {"endpoint_text":"- Change in Score from Baseline in Global Health Status/QoL Score (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) items 29 and 30)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 items 29 and 30 (global health status/QoL)."}
- {"endpoint_text":"- Change in Score from Baseline in Dyspnea score (EORTC QLQ-C30 item 8)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 item 8 (dyspnea)."}
- {"endpoint_text":"- Change in Score from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) item 31)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-LC13 item 31 (cough)."}
- {"endpoint_text":"- Change in Score from Baseline in Chest pain (EORTC QLQ-LC13 item 40)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-LC13 item 40 (chest pain)."}
- {"endpoint_text":"- Time to Deterioration from Baseline in Global Health Status/QoL Score (EORTS QLQ-C30 items 29 and 30)","definition_or_measurement_approach":"Time to deterioration in EORTC QLQ-C30 items 29 and 30 (global health status/QoL)."}
- {"endpoint_text":"- Time to Deterioration from Baseline in Dyspnea score (EORTC QLQ-C30 item 8)","definition_or_measurement_approach":"Time to deterioration in EORTC QLQ-C30 item 8 (dyspnea)."}
- {"endpoint_text":"- Time to Deterioration from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) item 31)","definition_or_measurement_approach":"Time to deterioration in EORTC QLQ-LC13 item 31 (cough)."}
- {"endpoint_text":"- Time to Deterioration from Baseline in Chest pain (EORTC QLQ-LC13 item 40)","definition_or_measurement_approach":"Time to deterioration in EORTC QLQ-LC13 item 40 (chest pain)."}
- {"endpoint_text":"- Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants experiencing ≥1 adverse event (AE); safety/tolerability monitoring (standard AE reporting)."}
- {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants discontinuing study treatment due to AE (as reported in safety data)."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Advocacy materials referenced (e.g., 'K2_Recruitment Doc Advocacy Card_DEU_DE_SM05_for pub' listed) — no specific registry or advocacy group name provided in the available extract.
- Digital Remote Recruitment
- True, digital/remote methods referenced via website materials (e.g., 'K2_Recruitment Doc Website_POL_PL'), ClinCard/ConneX travel/online patient card materials and other electronic patient information leaflets (documents listed for multiple countries).
- Planned Sample Size
- 455
- Recruitment Window Months
- 68
- Consent Approach
- Informed consent obtained from adult participants (minimum age ≥18). Country-specific main consent forms and information sheets (L1_ICF_Main consent documents) are available for DEU, CZE, GRC, FRA, ITA, POL, ESP and others; additional optional addenda and GDPR/data privacy documents are provided per country. No assent for minors is described.
Methods
- Site-based recruitment via participating hospitals/clinics (site lists and contact persons provided for each country).
- Use of recruitment materials (documented in K2 documents): patient brochures, patient visit guides, posters, master tissue brochures and invitation letters (country-specific K2_Recruitment Doc files for DEU, CZE, GRC, FRA, ITA, POL, ESP).
- Use of central recruitment materials and procedures (K1_Recruitment Arrangements and IC Procedure documents, country-specific).
- Digital recruitment/support materials: website presence (K2_Recruitment Doc Website_POL_PL), online ClinCard/ConneX travel/ClinCard materials (documents listed), and other electronic patient information templates.
Geography
- Total Number Of Sites
- 41
- Total Number Of Participants
- 107
Germany
- Earliest CTIS Part Ii Submission Date
- 07-12-2023
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 790
- Number Of Sites
- 6
- Number Of Participants
- 15
Sites
- Site Name
- Technische Universitat Dresden
- Department Name
- Medizinische Fakultät Carl Gustav Carus Med. Klinik I
- Contact Person Name
- Felix Saalfeld
- Contact Person Email
- felix.saalfeld@uniklinikum-dresden.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Klinik für Innere Medizin IV
- Contact Person Name
- Sebastian Ertl
- Contact Person Email
- onkologie@kem-med.com
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Klinik für Innere Medizin IV
- Contact Person Name
- Stefan Hammerschmidt
- Contact Person Email
- s.hammerschmidt@skc.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Klinik für Pneumologie
- Contact Person Name
- Claas Wesseler
- Contact Person Email
- c.wesseler@asklepios.com
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Hämatologie und Medizinische Onkologie
- Contact Person Name
- Tobias Overbeck
- Contact Person Email
- haematologie.studiensekretariat@med.uni-goettingen.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Innere Medizin I
- Contact Person Name
- Justyna Rawluk
- Contact Person Email
- justyna.rawluk@uniklinik-freiburg.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 13-10-2023
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 845
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Onkologická klinika
- Contact Person Name
- Milada Zemanova
- Contact Person Email
- milada.zemanova@vfn.cz
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- Klinika pneumologie a ftizeologie
- Contact Person Name
- Martin Svatoň
- Contact Person Email
- SVATONM@fnplzen.cz
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Klinika komplexni onkologicke pece
- Contact Person Name
- Ondřej Bílek
- Contact Person Email
- bilek@mou.cz
- Site Name
- Nemocnice AGEL Ostrava-Vitkovice a.s.
- Department Name
- Plicni oddeleni
- Contact Person Name
- Jaromír Roubec
- Contact Person Email
- jaromir.roubec@vtn.agel.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Klinika plicnich nemoci a tuberkulozy
- Contact Person Name
- Juraj Kultan
- Contact Person Email
- juraj.kultan@fnol.cz
Greece
- Earliest CTIS Part Ii Submission Date
- 21-12-2023
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 777
- Number Of Sites
- 6
- Number Of Participants
- 18
Sites
- Site Name
- Henry Dunant Hospital Center
- Department Name
- D Oncology department
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Papageorgiou General Hospital of Thessaloniki Molecular Medicine Clinical Trials Department
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 3rd Department of Internal Medicine and Laboratory - Oncology Unit
- Contact Person Name
- Konstantinos Syrigos
- Contact Person Email
- ksyrigos.trials@gmail.com
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 4th Department of Internal Medicine Hematology Oncology Unit, NKUA
- Contact Person Name
- Anna Koumarianou
- Contact Person Email
- akoumari@yahoo.es
- Site Name
- Areteio Hospital
- Department Name
- Oncology Unit, B' Surgery Department
- Contact Person Name
- Flora Zagouri
- Contact Person Email
- florazagouri@yahoo.co.uk
- Site Name
- Theageneio Cancer Hospital
- Department Name
- 1st Department of Medical Oncology
- Contact Person Name
- Pavlos Papakotoulas
- Contact Person Email
- papakotoulas@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 07-12-2023
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 795
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Oncology
- Contact Person Name
- Maurice Perol
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Oncology
- Contact Person Name
- Sophie Cousin
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- medical oncology departement
- Contact Person Name
- Carole Helissey
- Contact Person Email
- carole.helissey@gmail.com
- Site Name
- CHU De Rouen
- Department Name
- Pneumology, intensive care and thoracic oncology
- Contact Person Name
- Florian Guisier
- Contact Person Email
- florian.guisier@chu-rouen.fr
- Site Name
- Institut Curie
- Department Name
- Oncology
- Contact Person Name
- Catherine Daniel
- Contact Person Email
- catherine.daniel@curie.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 07-12-2023
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 791
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Medica
- Contact Person Name
- Angelo Delmonte
- Contact Person Email
- angelo.delmonte@irst.emr.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Oncologia Medica 2
- Contact Person Name
- Federico Cappuzzo
- Contact Person Email
- federico.cappuzzo@ifo.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Struttura Complessa Oncologia Medica 1
- Contact Person Name
- Arsela Prelaj
- Contact Person Email
- arsela.prelaj@istitutotumori.mi.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Oncologia medica ed ematologia (Cancer Center)
- Contact Person Name
- Giovanna Finocchiaro
- Contact Person Email
- giovanna.finocchiaro@cancercenter.humanitas.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Contact Person Name
- Emilio Bria
- Contact Person Email
- emilio.bria@policlinicogemelli.it
Poland
- Earliest CTIS Part Ii Submission Date
- 21-12-2023
- Latest Decision Or Authorization Date
- 08-02-2026
- Processing Time Days
- 780
- Number Of Sites
- 7
- Number Of Participants
- 18
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Centrum Innowacyjnych Terapii
- Contact Person Name
- Tomasz Jankowski
- Contact Person Email
- onkotorun@gmail.com
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Klinika Onkologii Klinicznej
- Contact Person Name
- Kinga Szydziak – Zwierzyńska
- Contact Person Email
- badania.kliniczne@onkol.kielce.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- badania.kliniczne@co.bydgoszcz.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
- Department Name
- Oddzial w Gliwicach II Klinika Radioterapii i Chemioterapii
- Contact Person Name
- Adam Idasiak
- Contact Person Email
- CWBK@gliwie.nio.gv.pl
- Site Name
- INSTYTUT GRUŹLICY I CHORÓB PŁUC
- Department Name
- III Klinika Chorób Płuc i Onkologii
- Contact Person Name
- Mateusz Polaczek
- Contact Person Email
- bk3@igichp.edu.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
- Department Name
- Klinika Nowotworow Pluca i Klatki Piersiowej
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- dariusz.kowalski@nio.gov.pl
- Site Name
- Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
- Department Name
- Oddzial Onkologiczny z Pododdzialem Dziennej Chemioterapii
- Contact Person Name
- Kamil Kuć
- Contact Person Email
- kkuc@wszp.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 12-12-2023
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 821
- Number Of Sites
- 7
- Number Of Participants
- 16
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Contact Person Name
- Antonio Calles
- Contact Person Email
- antonio.calles@salud.madrid.org
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Contact Person Name
- Gonzalo Fernández
- Contact Person Email
- gfernandezh@unav.es
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Medical Oncology
- Contact Person Name
- Delvys Rodríguez
- Contact Person Email
- drodabr@gobiernodecanarias.org
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Medical Oncology
- Contact Person Name
- Belén Rubio
- Contact Person Email
- ensayosoncologia.mad@quironsalud.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Contact Person Name
- Enriqueta Felip
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Contact Person Name
- Noemi Reguart
- Contact Person Email
- NREGUART@clinic.cat
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Medical Oncology
- Contact Person Name
- Manuel Cobo
- Contact Person Email
- manuelcobodols@yahoo.es
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Eresearchtechnology Inc.
- Responsibilities
- sponsorDuties codes: 7
- Name
- Iqvia Laboratories Limited
- Responsibilities
- sponsorDuties codes: 4
- Name
- Signant Health Global Solutions Limited
- Responsibilities
- sponsorDuties codes: 3
- Name
- Bioclinica Inc.
- Responsibilities
- Central imaging (sponsorDuties code 15)
- Name
- Roche Diagnostics GmbH
- Responsibilities
- sponsorDuties codes: 4
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services) (sponsorDuties code 15)
- Name
- Frontage Laboratories Inc.
- Responsibilities
- sponsorDuties codes: 4
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties: 15; value: Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties: 15; value: EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MK-2870
- Active Substance
- SACITUZUMAB TIRUMOTECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Investigational
- Maximum Dose
- 4 mg/kg
- Investigational Product Name
- DOCETAXEL
- Active Substance
- ANHYDROUS DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 75 mg/m2
- Investigational Product Name
- PEMETREXED
- Active Substance
- PEMETREXED
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 500 mg/m2
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