Clinical trial • Phase II • Oncology

IFINATAMAB DERUXTECAN for Squamous non-small cell lung cancer (stage IV)

Phase II trial of IFINATAMAB DERUXTECAN for Squamous non-small cell lung cancer (stage IV).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Squamous non-small cell lung cancer (stage IV)
Trial Stage
Phase II
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
25-04-2025
First CTIS Authorization Date
13-08-2025

Trial design

Randomised, docetaxel — comparator; intravenous infusion; dose information in record: 75 mg/m2 (doseuom: mg/m2; maxdailydoseamount: 75). schedule not specified in the provided record.-controlled, adaptive Phase II trial in Germany, Hungary, Italy and others.

Randomised
Yes
Comparator
DOCETAXEL — comparator; intravenous infusion; dose information in record: 75 mg/m2 (doseUom: mg/m2; maxDailyDoseAmount: 75). Schedule not specified in the provided record.
Adaptive
True — umbrella, randomized study with rolling arms (adaptive/rolling-arm design is indicated by title/description: 'Umbrella Study With Rolling Arms'); specific adaptive rules (interim analyses, stopping rules, arm-add/drop criteria) not detailed in the provided record.
Target Sample Size
86
Trial Duration For Participant
730

Eligibility

Recruits 86 Vulnerable population not selected (isVulnerablePopulationSelected: false). Trial enrols adult patients; HIV-infected participants are allowed if HIV is well controlled on ART. Subject information and informed consent forms for adults are provided (country-specific ICFs listed). No paediatric or specific vulnerable/assent procedures are indicated in the record..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected: false). Trial enrols adult patients; HIV-infected participants are allowed if HIV is well controlled on ART. Subject information and informed consent forms for adults are provided (country-specific ICFs listed). No paediatric or specific vulnerable/assent procedures are indicated in the record.

Inclusion criteria

  • {"criterion_text":"-Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)"}
  • {"criterion_text":"-Has documented disease progression per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/ programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease"}
  • {"criterion_text":"-Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)"}
  • {"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"}

Exclusion criteria

  • {"criterion_text":"-Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements"}
  • {"criterion_text":"-History of (noninfectious) pneumonitis/Interstitial Lung Disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis"}
  • {"criterion_text":"-Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed"}
  • {"criterion_text":"-Active infection requiring systemic therapy"}
  • {"criterion_text":"-HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
  • {"criterion_text":"-Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)"}
  • {"criterion_text":"-Known history of, or active, neurologic paraneoplastic syndrome"}
  • {"criterion_text":"-History of allogeneic tissue/solid organ transplant"}
  • {"criterion_text":"-Has not adequately recovered from major surgery or have ongoing surgical complications"}
  • {"criterion_text":"-Has uncontrolled or significant cardiovascular disorder"}
  • {"criterion_text":"-Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc), or prior pneumonectomy"}
  • {"criterion_text":"-Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline"}
  • {"criterion_text":"-Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection)"}
  • {"criterion_text":"-Has clinically significant corneal disease"}
  • {"criterion_text":"-Known additional malignancy that is progressing or has required active treatment within the past 3 years"}
  • {"criterion_text":"-Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis"}
  • {"criterion_text":"-Evidence of any leptomeningeal disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Objective Response Rate (ORR)","definition_or_measurement_approach":"OR assessed per RECIST 1.1 as evaluated by Blinded Independent Central Review (BICR) (trial objective: \"To evaluate the OR per RECIST 1.1 as assessed by BICR\")."}
  • {"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); standard AE reporting per protocol (number of participants with one or more AEs)."}
  • {"endpoint_text":"-Number of participants who discontinue study intervention due to an AE","definition_or_measurement_approach":"Count of participants who permanently discontinue the study intervention because of an AE (as recorded in trial safety reporting)."}

Secondary endpoints

  • {"endpoint_text":"-Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by BICR (secondary objective: \"To evaluate the DOR per RECIST 1.1 as assessed by BICR\")."}
  • {"endpoint_text":"-Progression-free Survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by BICR (secondary objective: \"To evaluate PFS per RECIST 1.1 as assessed by BICR\")."}
  • {"endpoint_text":"-Overall Survival (OS)","definition_or_measurement_approach":"Overall survival measured from randomisation/enrolment to death from any cause (secondary objective: \"To evaluate OS\")."}

Recruitment

Planned Sample Size
86
Recruitment Window Months
80
Consent Approach
Informed consent obtained from adult participants. Country-specific subject information and ICF documents are provided (examples: L1_ICF_Main consent adult_GRC_EL_SM02_for pub and multiple country ICFs listed for HUN, ITA, ESP, POL, DEU, EN). Optional addenda/optional consents (e.g., progression addendum, pregnant partner follow-up, genetic consent) are included as separate documents. No paediatric assent procedures described.

Geography

Total Number Of Sites
19
Total Number Of Participants
66

Germany

Earliest CTIS Part Ii Submission Date
22-07-2025
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
247
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Infektiologie/Pneumologie
Contact Person Name
Nikolaj Frost
Contact Person Email
studien-pneumologie@charite.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik VIII
Contact Person Name
Torben Groß

Hungary

Earliest CTIS Part Ii Submission Date
04-08-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
235
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonológiai Osztály
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
szalaizs@petz.gyor.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Zsuzsanna Kelemen
Contact Person Email
kelemenzs@kmk.hu
Site Name
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Department Name
Onkológiai Központ
Contact Person Name
Zsuzsanna Orosz
Contact Person Email
zsuzsa.orosz@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
04-07-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
269
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica
Contact Person Name
Emilio Bria
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Radioterapia Oncologica
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Oncologia Medica
Contact Person Name
Roberto Ferrara
Contact Person Email
ferrara.roberto@hsr.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology Department 1, Thoracic Oncology Unit
Contact Person Name
Giuseppe Lo Russo

Spain

Earliest CTIS Part Ii Submission Date
02-07-2025
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
267
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Medical Oncology
Contact Person Name
Belén Rubio Viqueira
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Ernest Nadal Alforja
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Laura Mezquita Perez
Contact Person Email
LMEZQUITA@clinic.cat

Poland

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
263
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Centrum Wsparcia Badań Klinicznych UCK, Ośrodek Badań Klinicznych Wczesnych Faz
Contact Person Name
Katarzyna Szymczak
Contact Person Email
obkwf@uck.gda.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddzial Dzienny Chemioterapii
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
malgorzata.kozlik@nio.gov.pl
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org

Greece

Earliest CTIS Part Ii Submission Date
07-05-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
327
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Evangelismos S.A.
Department Name
Oncology Department
Contact Person Name
Theodoros Tegos
Contact Person Email
th_tegos@yahoo.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@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
PPD Global Central Labs
Name
Almac Clinical Technologies LLC
Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting)
Name
ICON clinical Research Ltd.
Responsibilities
Central imaging/BICR
Name
Ventana (Roche Tissue Diagnostics)

Third parties

  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"ICON clinical Research Ltd.","duties_or_roles":"Central imaging/BICR","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Ventana (Roche Tissue Diagnostics)","duties_or_roles":"code 4","organisation_type":"Industry"}

Co-sponsors

  • Daiichi Sankyo

Investigational products

Investigational Product Name
Ifinatamab Deruxtecan
Active Substance
IFINATAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Maximum Dose
12 mg/kg
Investigational Product Name
Raludotatug Deruxtecan
Active Substance
RALUDOTATUG DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Maximum Dose
5.6 mg/kg
Investigational Product Name
DOCETAXEL
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Maximum Dose
75 mg/m2

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