Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Non-small cell lung cancer

Phase III trial of SACITUZUMAB TIRUMOTECAN for Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
07-03-2024
First CTIS Authorization Date
24-06-2024

Trial design

Randomised, open-label, platinum-based doublet chemotherapy (carboplatin and pemetrexed). carboplatin (intravenous infusion; dose information present: maxdailydoseamount 5, maxtotaldoseamount 20; mia/identifier: imp11011/00003). pemetrexed (intravenous infusion; maxdailydoseamount 500 mg/m2).-controlled Phase III trial in Sweden, Poland, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Platinum-based doublet chemotherapy (carboplatin and pemetrexed). Carboplatin (intravenous infusion; dose information present: maxDailyDoseAmount 5, maxTotalDoseAmount 20; MIA/identifier: IMP11011/00003). Pemetrexed (intravenous infusion; maxDailyDoseAmount 500 mg/m2).
Biomarker Stratified
True, biomarker: EGFR mutation (EGFR-mutated NSCLC)
Target Sample Size
420

Eligibility

Recruits 420 No vulnerable populations selected; the trial enrols adult patients. Informed consent is obtained from participants (country-specific ICFs available); assent not applicable..

Vulnerable Population
No vulnerable populations selected; the trial enrols adult patients. Informed consent is obtained from participants (country-specific ICFs available); assent not applicable.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC)."}
  • {"criterion_text":"- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade <1 or baseline."}
  • {"criterion_text":"- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load."}
  • {"criterion_text":"- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable."}
  • {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy."}
  • {"criterion_text":"- Life expectancy of at least 3 months."}

Exclusion criteria

  • {"criterion_text":"- Predominantly squamous cell histology NSCLC."}
  • {"criterion_text":"- History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years."}
  • {"criterion_text":"- Grade >2 peripheral neuropathy."}
  • {"criterion_text":"- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing."}
  • {"criterion_text":"- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease."}
  • {"criterion_text":"- Uncontrolled, or significant cardiovascular disease or cerebrovascular disease."}
  • {"criterion_text":"- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids."}
  • {"criterion_text":"- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed."}
  • {"criterion_text":"- Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention."}
  • {"criterion_text":"- Known active central nervous system metastases and/or carcinomatous meningitis."}
  • {"criterion_text":"- Active infection requiring systemic therapy."}
  • {"criterion_text":"- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease."}
  • {"criterion_text":"- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease."}
  • {"criterion_text":"- Concurrent active HBV and HCV infection."}
  • {"criterion_text":"- History of allogeneic tissue/solid organ transplant."}
  • {"criterion_text":"- Participants who have not adequately recovered from major surgery or have ongoing surgical complications."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Overall survival (OS)"}

Secondary endpoints

  • {"endpoint_text":"- Objective response rate (ORR)","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- Duration of response (DOR)","definition_or_measurement_approach":"Duration of response (DOR)"}
  • {"endpoint_text":"- Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status (Item 29) and quality of life (Item 30) combined score","definition_or_measurement_approach":"Change from baseline in combined EORTC QLQ-C30 items 29 and 30"}
  • {"endpoint_text":"- Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 item 8 (dyspnea)"}
  • {"endpoint_text":"- Change from baseline in the cough (item 31) score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13)","definition_or_measurement_approach":"Change from baseline in QLQ-LC13 item 31 (cough)"}
  • {"endpoint_text":"- Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13","definition_or_measurement_approach":"Change from baseline in QLQ-LC13 item 40 (chest pain)"}
  • {"endpoint_text":"- Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30","definition_or_measurement_approach":"Time to deterioration in combined EORTC QLQ-C30 items 29 and 30"}
  • {"endpoint_text":"- TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to deterioration in EORTC QLQ-C30 item 8 (dyspnea)"}
  • {"endpoint_text":"- TTD in the cough (item 31) score, on the EORTC QLQ-LC13","definition_or_measurement_approach":"Time to deterioration in QLQ-LC13 item 31 (cough)"}
  • {"endpoint_text":"- TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13","definition_or_measurement_approach":"Time to deterioration in 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 AE"}
  • {"endpoint_text":"- Number of participants who discontinue study treatment due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment because of an AE"}

Recruitment

Digital Remote Recruitment
True, website-based recruitment materials documented (Poland). No additional remote/digital recruitment methods explicitly described.
Planned Sample Size
420
Recruitment Window Months
73
Consent Approach
Informed consent obtained from adult participants; country-specific subject information and informed consent forms (ICFs) are available in local languages (examples: Italian, Polish, French, Spanish, Swedish). Optional consent modules (e.g., optional samples, optional partner/pregnant partner modules) are documented. Assent procedures not applicable (no vulnerable populations selected).

Methods

  • Site-based recruitment via participating hospital/clinic oncology sites (sites listed in Italy, France, Spain, Poland, Sweden).
  • Use of country-specific recruitment materials (patient brochures, flyers, posters, patient visit guides) — documented versions available for Sweden, Poland, Italy, France, Spain (see K1/K2 recruitment documents).
  • Website-based recruitment materials (documented for Poland: K2_Recruitment Doc Website_POL_PL).

Geography

Total Number Of Sites
17
Total Number Of Participants
100

Sweden

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
647
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Karolinska University Hospital
Department Name
Lungonkologiskt centrum
Principal Investigator Name
Simon Ekman
Principal Investigator Email
simon.ekman@ki.se
Contact Person Name
Simon Ekman
Contact Person Email
simon.ekman@ki.se

Poland

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
08-03-2026
Processing Time Days
636
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Zurawski
Principal Investigator Email
badania.kliniczne@co.bydgoszcz.pl
Contact Person Name
Bogdan Zurawski
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Oddzial w Gliwicach II Klinika Radioterapii i Chemioterapii
Principal Investigator Name
Adam Idasiak
Principal Investigator Email
adam.idasiak@gliwice.nio.gov.pl
Contact Person Name
Adam Idasiak
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Nowotworow Pluca i Klatki Piersiowej
Principal Investigator Name
Dariusz Kowalski
Principal Investigator Email
paulina.kukwa@nio.gov.pl
Contact Person Name
Dariusz Kowalski
Contact Person Email
paulina.kukwa@nio.gov.pl

Italy

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
628
Number Of Sites
5
Number Of Participants
41

Sites

Site Name
Careggi University Hospital
Department Name
OD ONCOLOGIA MEDICA
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
lorenzo.antonuzzo@unifi.it
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@unifi.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Toracica
Principal Investigator Name
Antonio Passaro
Principal Investigator Email
antonio.passaro@ieo.it
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica per la Patologia Toracica
Principal Investigator Name
Domenico Galetta
Principal Investigator Email
galetta@oncologico.bari.it
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Medical Oncology Dept
Principal Investigator Name
Emilio Bria
Principal Investigator Email
emilio.bria@policlinicogemelli.it
Contact Person Name
Emilio Bria
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Principal Investigator Name
Arsela Prelaj
Principal Investigator Email
arsela.prelaj@istitutotumori.mi.it
Contact Person Name
Arsela Prelaj

France

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
639
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Hopital Prive Clairval
Department Name
Département de radiothérapie
Principal Investigator Name
Jean-Baptiste Paoli
Principal Investigator Email
jb.paoli@free.fr
Contact Person Name
Jean-Baptiste Paoli
Contact Person Email
jb.paoli@free.fr
Site Name
Institut Gustave Roussy
Department Name
Médecine Oncologique
Principal Investigator Name
David Planchard
Principal Investigator Email
david.planchard@gustaveroussy.fr
Contact Person Name
David Planchard
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Unité d'Oncologie Thoracique - Service de pneumologie
Principal Investigator Name
Marie Wislez
Principal Investigator Email
marie.wislez@aphp.fr
Contact Person Name
Marie Wislez
Contact Person Email
marie.wislez@aphp.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Recherche Clinique et Pneumologie - Pôle de Pathologie Thoracique
Principal Investigator Name
Bertrand Mennecier
Principal Investigator Email
bertrand.mennecier@chru-strasbourg.fr
Contact Person Name
Bertrand Mennecier

Spain

Earliest CTIS Part Ii Submission Date
27-05-2024
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
658
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Institut Catala D'oncologia
Department Name
Department of Oncology
Principal Investigator Name
Ernest Nadal Alforja
Principal Investigator Email
contactfortrialsICOLH@iconcologia.net
Contact Person Name
Ernest Nadal Alforja
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Department of Oncology
Principal Investigator Name
Luís León Mateos
Principal Investigator Email
Luis.Angel.Leon.Mateos@sergas.es
Contact Person Name
Luís León Mateos
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Department of Oncology
Principal Investigator Name
Ángel Inoriza Rueda
Principal Investigator Email
angel.inoriza@hotmail.com
Contact Person Name
Ángel Inoriza Rueda
Contact Person Email
angel.inoriza@hotmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Department of Oncology
Principal Investigator Name
David Vicente Baz
Principal Investigator Email
david.vbaz@gmail.com
Contact Person Name
David Vicente Baz
Contact Person Email
david.vbaz@gmail.com

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
Adjudication
Name
IQVIA Limited
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Bioclinica Inc.
Responsibilities
Central imaging
Name
Signant Health Global Solutions Limited
Name
Roche Diagnostics GmbH

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Adjudication","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
MIA number: IMP11011/00003
Maximum Dose
624 mg/kg (maxTotalDoseAmount 624; doseUom mg/kg)
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Comparator product (part of platinum doublet); MIA number: IMP11011/00003
Maximum Dose
maxDailyDoseAmount 5 (unit: Other); maxTotalDoseAmount 20 (unit: Other)
Investigational Product Name
PEMETREXED
Active Substance
PEMETREXED DISODIUM
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Comparator product (part of platinum doublet); MIA number: IMP11011/00003
Maximum Dose
500 mg/m2 (maxDailyDoseAmount 500 mg/m2)
Combination Treatment
Yes

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