Clinical trial • Phase III • Oncology

RILVEGOSTOMIG for Non-small cell lung cancer (adenocarcinoma) — Stage I

Phase III trial of RILVEGOSTOMIG for Non-small cell lung cancer (adenocarcinoma) — Stage I.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (adenocarcinoma) — Stage I
Trial Stage
Phase III
Drug Modality
Bispecific antibody|ADC

Key dates

Initial CTIS Submission Date
14-10-2024
First CTIS Authorization Date
17-02-2025

Trial design

Randomised, open-label, standard of care (soc): observation only or investigator’s choice of chemotherapy (icc). comparator chemotherapies listed as examples in the application: pemetrexed; cisplatin; carboplatin; etoposide; vinorelbine. dose and schedule for soc/icc not specified in the public record.-controlled Phase III trial in Belgium, France, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard of Care (SoC): observation only or Investigator’s Choice of Chemotherapy (ICC). Comparator chemotherapies listed as examples in the application: Pemetrexed; Cisplatin; Carboplatin; Etoposide; Vinorelbine. Dose and schedule for SoC/ICC not specified in the public record.
Target Sample Size
541

Eligibility

Recruits 541 Vulnerable population considerations: the trial record marks vulnerable population selected. Subject information and informed consent documents include specific materials for 'pregnant partners' (documents titled 'L1_SIS and ICF pregnant partner' / 'L1_SIS and ICF Pregnant Partners'), indicating separate information/consent handling for pregnant partners. Informed consent is obtained from adult participants; separate ICF materials exist for pregnant partners and language-specific ICFs are provided. No paediatric assent documents are present..

Vulnerable Population
Vulnerable population considerations: the trial record marks vulnerable population selected. Subject information and informed consent documents include specific materials for 'pregnant partners' (documents titled 'L1_SIS and ICF pregnant partner' / 'L1_SIS and ICF Pregnant Partners'), indicating separate information/consent handling for pregnant partners. Informed consent is obtained from adult participants; separate ICF materials exist for pregnant partners and language-specific ICFs are provided. No paediatric assent documents are present.

Inclusion criteria

  • {"criterion_text":"- Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed) adenocarcinoma NSCLC"}
  • {"criterion_text":"- Complete surgical resection (R0) of the primary NSCLC"}
  • {"criterion_text":"- Unequivocal no evidence of disease at post-surgical baseline scan"}
  • {"criterion_text":"- Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)"}
  • {"criterion_text":"- ECOG of 0 or 1, life expectancy of > 6 months and complete recovery after surgery"}
  • {"criterion_text":"- Adequate bone marrow reserve and organ function"}

Exclusion criteria

  • {"criterion_text":"- Sensitizing EGFR mutation and/or ALK alteration"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- Significant pulmonary function compromise"}
  • {"criterion_text":"- History of another primary malignancy within 3 years (with exceptions)"}
  • {"criterion_text":"- Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease"}
  • {"criterion_text":"- Active or prior documented autoimmune or inflammatory disorders (with exceptions)"}
  • {"criterion_text":"- Active infection with tuberculosis, hepatitis A, B or C virus, or known HIV infection that is not well controlled"}
  • {"criterion_text":"- History of active primary immunodeficiency"}
  • {"criterion_text":"- Clinically significant corneal disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC","definition_or_measurement_approach":"Assessment of Disease-Free Survival (DFS) by Blinded Independent Central Review (BICR)."}

Secondary endpoints

  • {"endpoint_text":"- OS (Overall Survival): The analysis will include all randomised participants as randomised. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.","definition_or_measurement_approach":"Overall Survival (OS) analysis of all randomised participants; measure of interest is hazard ratio (HR) of OS; all deaths included."}
  • {"endpoint_text":"- Participant-reported physical function: The analysis will include all randomised participants as randomised. The measure of interest will be the between treatment group difference in adjusted mean in physical function scores at Weeks 12, 24 and 48.","definition_or_measurement_approach":"Between-group difference in adjusted mean physical function scores at Weeks 12, 24 and 48 (participant-reported outcomes)."}
  • {"endpoint_text":"- Participant-reported GHS/QoL: The analysis will include all randomised participants as randomised. The measure of interest will be the between treatment group difference in adjusted mean in GHS/QoL scores at Weeks 12, 24 and 48.","definition_or_measurement_approach":"Between-group difference in adjusted mean Global Health Status/Quality of Life (GHS/QoL) scores at Weeks 12, 24 and 48 (participant-reported)."}
  • {"endpoint_text":"- Pharmacokinetics (PK): Concentration of rilvegostomig, Dato-DXd, total anti‑TROP2 antibody, and MAAA‑1181a (payload deruxtecan) in serum or plasma and PK parameters (peak and trough concentrations).","definition_or_measurement_approach":"Measurement of serum/plasma concentrations of rilvegostomig, Dato-DXd, total anti‑TROP2 antibody, and MAAA‑1181a; PK parameters including peak and trough concentrations."}
  • {"endpoint_text":"- Immunogenicity: Presence of ADAs for Dato-DXd and rilvegostomig (confirmatory results: titres and neutralizing antibodies for confirmed positive samples).","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) for Dato-DXd and rilvegostomig; confirmatory titres and neutralizing antibody testing for confirmed positives."}

Recruitment

Planned Sample Size
541
Recruitment Window Months
121
Consent Approach
Informed consent is obtained using subject information sheets and informed consent forms (SIS and ICF). Country- and language-specific ICF materials are provided (multiple L1/L2 documents listed per country). Separate ICF materials exist for pregnant partners and for optional genomic/future research; pre-screening ICFs and adult screening part 1/part 2 ICFs are provided. Consent is provided by adult participants; materials are available in multiple languages per country (e.g., country-specific ICFs and translations listed).

Geography

Total Number Of Sites
48
Total Number Of Participants
119

Belgium

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
313
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Jessa Ziekenhuis
Department Name
Pneumology
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Antwerp University Hospital
Department Name
Department Pulmonary Medicine - Thoracic Oncology
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be

France

Earliest CTIS Part Ii Submission Date
11-02-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
294
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Hospital Foch
Department Name
Oncologie et soins de supports
Contact Person Name
Jaafar Bennouna
Contact Person Email
j.bennouna@hopital-foch.com
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Oncologie thoracique
Contact Person Name
Florian Guisier
Contact Person Email
florian.guisier@chu-rouen.fr
Site Name
Institut Curie
Department Name
Pneumologie
Contact Person Name
Nicolas Girard
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Institut Gustave Roussy
Department Name
Oncologie medical
Contact Person Name
Jordi Remon Masip
Site Name
HIA Sainte Anne
Department Name
URC - HIA SAINTE ANNE
Contact Person Name
Olivier BYLICKI
Contact Person Email
bylicki.olivier@yahoo.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Pneumologie
Contact Person Name
Youssef OULKHOUIR
Contact Person Email
youssed.oulkhouir@chu-anger.fr

Germany

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
324
Number Of Sites
12
Number Of Participants
34

Sites

Site Name
Vincentius-Diakonissen-Kliniken gAG
Department Name
Medizinische Klinik 2
Contact Person Name
Christian Meyer zum Bueschenfelde
Contact Person Email
christian.mzb@vincentius-ka.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik III - Innere Medizin
Contact Person Name
Franz-Georg Bauernfeind
Site Name
Franziskus Hospital Harderberg
Department Name
MVZ II, Sektion Thoraxonkologie
Contact Person Name
Petra Hoffknecht
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
MVZ Pneumologie
Contact Person Name
Christian Schumann
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik fuer Kardiologie, Angiologie und Pneumologie
Contact Person Name
Martin Faehling
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
2. Medizinische Klinik
Contact Person Name
Dagmar Taeuscher
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Studienzentrale Organonkologie
Contact Person Name
Thomas Wehler
Site Name
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Department Name
Studienzentrale
Contact Person Name
Ruediger Liersch
Contact Person Email
liersch@onkologie-muenster.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Lungenkrebszentrum am Westdeutsches Tumorzentrum (LWTZ)
Contact Person Name
Servet Boeluekbas
Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Thoraxzentrum
Contact Person Name
Joerg Kluge
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Thorakale Onkologie
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Klinikum Wuerzburg Mitte gGmbH
Department Name
Innere - Schwerpunkt Pneumologie
Contact Person Name
Jens Kern
Contact Person Email
jens.kern@kwm-klinikum.de

Spain

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
298
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Contact Person Name
Alexandre Martínez Martí
Contact Person Email
amartinezmarti@vhio.net
Site Name
Hospital Quironsalud Malaga
Department Name
Oncología
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncología
Contact Person Name
Dolores Isla Casado
Contact Person Email
disla@salud.aragon.es
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncología
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
bmassutis@seom.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncología
Contact Person Name
Manuel Dómine Gómez
Contact Person Email
mdomine@fjd.es
Site Name
Hospital Del Mar
Department Name
Oncología
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@psmar.cat
Site Name
Hospital Del Mar (additional listed site)
Department Name
Oncología
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@psmar.cat

Netherlands

Earliest CTIS Part Ii Submission Date
05-02-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
299
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Longgeneeskunde
Contact Person Name
Robin Cornelissen
Contact Person Email
r.cornelissen@erasmusmc.nl

Sweden

Earliest CTIS Part Ii Submission Date
24-01-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
308
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Karolinska University Hospital
Department Name
LungOnkologiskt centrum
Contact Person Name
Oscar Grundberg

Poland

Earliest CTIS Part Ii Submission Date
12-11-2024
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
384
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddzial Torakochirurgii
Contact Person Name
Cezary Piwkowski
Contact Person Email
cpiwkowski@wcpit.org
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddzal Onkologii z Pododdzialem Chemioterapii
Contact Person Name
Jaroslaw Kolb-Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
III Klinika Chorob Pluc i Onkologii
Contact Person Name
Mateusz Polaczek
Contact Person Email
m.polaczek@igichp.edu.pl

Hungary

Earliest CTIS Part Ii Submission Date
16-12-2024
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
350
Number Of Sites
10
Number Of Participants
15

Sites

Site Name
University Of Debrecen
Department Name
Tüdőgyógyászati Klinika
Contact Person Name
Tamás Kardos
Contact Person Email
kardostom@yahho.co.uk
Site Name
University Of Pecs
Department Name
Klinikai Központ, Onkoterápiás Intézet
Contact Person Name
Árpád Boronkai
Contact Person Email
arpad.boronkai@gmail.com
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
I. Tüdőgyógyászati Osztály
Contact Person Name
Judit Moldvay
Contact Person Email
moldvay@koranyi.hu
Site Name
Clinexpert Kft.
Contact Person Name
István Albert
Contact Person Email
albert.magy@gmail.com
Site Name
Reformatus Pulmonologiai Centrum
Contact Person Name
Gabriella Gálffy
Site Name
Orszagos Onkologiai Intezet
Department Name
Gyógyszerterápiás Központ Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály
Contact Person Name
Tünde Nagy
Contact Person Email
nagy.tunde@oncol.hu
Site Name
University Of Szeged
Department Name
Tüdőgyógyászati Klinika
Contact Person Name
Katalin Gódorné Ugocsai
Contact Person Email
ugocsai.katalin@szte.hu
Site Name
Semmelweis University
Department Name
Pulmonológiai Klinika
Contact Person Name
Veronika Müller
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Pulmonológia Osztály
Contact Person Name
Zsolt Pápai-Székely
Contact Person Email
zsoltpapai@yahoo.com
Site Name
Matrai Gyogyintezet
Contact Person Name
István Albert
Contact Person Email
albert.magy@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
12-11-2024
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
386
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Unità di Oncologia Medica 2
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
UOC Oncologia Medica ed Ematologia
Contact Person Name
Luca Toschi
Site Name
Istituto Oncologico Veneto
Department Name
UOC Chirurgia, Oncologia e Gastroenterologia
Contact Person Name
Laura Bonanno
Contact Person Email
laura.bonanno@iov.veneto.it
Site Name
Careggi University Hospital
Department Name
Dipartimento di Medicina Sperimentale e Clinica
Contact Person Name
Lorenzo Antonuzzo
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica - Oncologia Toraco-Polmonare
Contact Person Name
Emilio Bria
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Diego Luigi Cortinovis

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Rilvegostomig
Active Substance
RILVEGOSTOMIG
Modality
Bispecific antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Frequency
Every 3 weeks (Q3W)
Investigational Product Name
Datopotamab deruxtecan
Active Substance
DATOPOTAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Frequency
Every 3 weeks (Q3W) (as per intervention description)
Combination Treatment
Yes

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