Clinical trial • Phase III • Oncology

RILVEGOSTOMIG for Metastatic squamous non-small cell lung cancer (PD-L1 expressing)

Phase III trial of RILVEGOSTOMIG for Metastatic squamous non-small cell lung cancer (PD-L1 expressing).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic squamous non-small cell lung cancer (PD-L1 expressing)
Trial Stage
Phase III
Drug Modality
Bispecific antibody|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
06-09-2024
First CTIS Authorization Date
16-01-2025

Trial design

Randomised, arm a: rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig. arm b (comparator): pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab.-controlled Phase III trial in Spain, France, Poland and others.

Randomised
Yes
Comparator
Arm A: Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig. Arm B (comparator): Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab.
Target Sample Size
648

Eligibility

Recruits 648 The trial record flags a vulnerable population selection (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided (adult ICFs and specific forms for pregnant partners are listed). No explicit text describing assent procedures for minors or detailed consent-by-proxy is provided in the available CTIS data..

Vulnerable Population
The trial record flags a vulnerable population selection (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided (adult ICFs and specific forms for pregnant partners are listed). No explicit text describing assent procedures for minors or detailed consent-by-proxy is provided in the available CTIS data.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically documented squamous NSCLC.\n- Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.\n- Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved targeted 1L therapies.\n- Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%\n- At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.\n- Adequate organ and bone marrow function"}

Exclusion criteria

  • {"criterion_text":"- Presence of small cell and neuroendocrine histology components.\n- Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.\n- Any prior systemic therapy received for advanced or mNSCLC.\n- Prior treatment with an anti-PD-1 or anti-PD-L1 agent.\n- Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.\n- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.\n- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n- Active primary immunodeficiency/active infectious disease(s)\n- Active tuberculosis infection"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Landmark overall survival (OS) rates","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Landmark progression-free survival (PFS) rates","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to second progression or death (PFS2)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall response rate (ORR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of response (DoR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Concentration of rilvegostomig in serum.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Presence of antidrug antibody (ADAs), titer and neutralizing antibodies for rilvegostomig.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Proportion of participants with maintained or improved physical functioning.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to deterioration (TTD) of global health status (GHS)/quality of life (QoL) and in pulmonary symptoms.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Adverse events (AEs) (graded by CTCAE version 5.0), clinical laboratory assessments, vital signs, and Eastern Cooperative Oncology Group (ECOG) performance status.","definition_or_measurement_approach":"AEs graded by CTCAE version 5.0; clinical laboratory assessments, vital signs and ECOG performance status as safety measures."}

Recruitment

Planned Sample Size
648
Recruitment Window Months
58
Consent Approach
Informed consent is obtained using subject information and informed consent form documents; adult participant ICFs and pregnant-partner ICFs are listed in the CTIS documents. Multiple country/language-specific ICF versions are provided (examples in the documents list include Spanish, French, German, Italian, Hungarian, Polish, Dutch and BE language variants). No explicit text describing assent or age-specific consent procedures for minors is present in the available CTIS data.

Geography

Total Number Of Sites
76
Total Number Of Participants
232

Spain

Earliest CTIS Part Ii Submission Date
03-12-2024
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
279
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
oncology
Contact Person Name
Pilar Garrido
Contact Person Email
pilargarridol@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
oncology
Contact Person Name
Rosa Alvarez
Contact Person Email
rosa.alvarez.al@gmail.com
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
oncology
Contact Person Name
Alberto Rodrigo
Contact Person Email
alberto.rcaceres@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
oncology
Contact Person Name
Ernest Nadal
Contact Person Email
ernestnadal@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
oncology
Contact Person Name
Reyes Bernabé
Contact Person Email
bernabeensayos@gmail.com
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
oncology
Contact Person Name
Delvys Rodriguez
Contact Person Email
delvysra@yahoo.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
oncology
Contact Person Name
Enriqueta Felip
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
oncology
Contact Person Name
Mariano Provencio

France

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
03-09-2025
Processing Time Days
320
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
HIA Sainte Anne
Department Name
Respiratory department
Contact Person Name
Olivier Bylicki
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Pneumology
Contact Person Name
Charles Ricordel
Contact Person Email
charles.ricordel@chu-rennes.fr
Site Name
Centre Hospitalier D Avignon
Department Name
Medical oncology and clinical hematology
Contact Person Name
Nicolas Cloarec
Contact Person Email
CLOAREC.Nicolas@ch-avignon.fr
Site Name
Centre Léon Bérard
Department Name
Medical oncology
Contact Person Name
Chantan Decoisette
Site Name
Hospital Foch
Department Name
Medical oncology
Contact Person Name
Jaafar Bennouna
Contact Person Email
j.bennouna@hopital-foch.com
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumology
Contact Person Name
Céline Mascaux
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Pneumology
Contact Person Name
Sylvie Van Hulst
Contact Person Email
sylvie.vanhulst@chu-nimes.fr
Site Name
C.H. La Rochelle
Department Name
Oncology
Contact Person Name
Claire Jamet

Poland

Earliest CTIS Part Ii Submission Date
03-12-2024
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
279
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii
Contact Person Name
Wojciech Solarek
Contact Person Email
wsolarek@wim.mil.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Ongologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Centrum Pulmonologii I Torakochirurgii W Bystrej
Department Name
Oddzial Pulmonologiczno – Onkologiczny z Chemioterapia
Contact Person Name
Adrianna Gega-Czarnota
Contact Person Email
adrianna.gega@gmail.com
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Odzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddzial Onkologii Klinicznej
Contact Person Name
Piotr Tokajuk
Contact Person Email
ptokajuk@gmail.com
Site Name
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Department Name
Oddzial Onkologii Klinicznej
Contact Person Name
Maria Pawlowicz
Contact Person Email
maria.pawlowicz@szpitabp.pl

Netherlands

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
02-09-2025
Processing Time Days
319
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Isala Klinieken Stichting
Department Name
Longgeneeskunde
Contact Person Name
Peter Plomp
Contact Person Email
p.m.j.plomp@isala.nl
Site Name
Haaglanden Medisch Centrum Stichting
Department Name
Pulmonology
Contact Person Name
Uzun Sevim
Contact Person Email
s.uzun@haaglandenmc.nl
Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Pulmonary diseases
Contact Person Name
Wouter Mellema
Contact Person Email
ww.mellema@nwz.nl
Site Name
Maxima Medisch Centrum
Department Name
Lung/Oncology
Contact Person Name
Magdolen Youssef - El Soud
Contact Person Email
m.youssef@mmc.nl
Site Name
Ziekenhuis Gelderse Vallei Stichting
Department Name
Pulmonology
Contact Person Name
Arthur Mulders
Contact Person Email
amulders@zgv.nl

Italy

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
03-09-2025
Processing Time Days
342
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Ongolocia Medica - UOS Oncologia Toraco-Polmonare
Contact Person Name
Emilio Bria
Site Name
Istituto Oncologico Veneto
Department Name
DEPARTMENT OF CLINICAL AND EXPERIMENTAL ONCOLOGY
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Department Name
U.O. di Oncologia Toracica - Lung Unit
Contact Person Name
Antonio Santo
Site Name
Careggi University Hospital
Department Name
SODc Clinical Oncology
Contact Person Name
Lorenzo Antonuzzo
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SCDU Medical Oncology
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Diego Luigi Cortinovis

Austria

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
02-09-2025
Processing Time Days
288
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
Internal E at LKH Rankweil
Contact Person Name
Thomas Winder
Contact Person Email
thomas.winder@lkhf.at
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Department for Internal Medicine and Pneumology
Contact Person Name
Maximilian Hochmair
Site Name
Stadt Wien Wiener Gesundheitsverbund (Ottakring)
Department Name
2. Medical Department with Pneumology
Contact Person Name
Georg-Christian Funk
Site Name
Universitaetsklinikum Krems
Department Name
Department Pneumology
Contact Person Name
Klaus Hackner
Contact Person Email
klaus.hackner@krems.lknoe.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Internal Medicine V
Contact Person Name
Florian Kocher
Contact Person Email
florian.kocher@i-med.ac.at

Hungary

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
05-09-2025
Processing Time Days
291
Number Of Sites
10
Number Of Participants
28

Sites

Site Name
Reformatus Pulmonologiai Centrum
Contact Person Name
Gabriella Gálffy
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Pulmonológiai Osztály
Contact Person Name
Zsolt Pápai-Székely
Contact Person Email
zsoltpapai@yahoo.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
University Of Debrecen
Department Name
Tüdőgyógyászati Klinika
Contact Person Name
Tamás Kardos
Contact Person Email
kardostom@yahoo.co.uk
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Odzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
clinstudy@gmail.com
Site Name
Clinexpert Kft.
Department Name
Fázis I. Vizsgálóhely
Contact Person Name
István Albert
Contact Person Email
albert.magy@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály, Kemoterápia B
Contact Person Name
Tünde Nagy
Contact Person Email
nagytunde67@yahoo.com
Site Name
University Of Pecs
Department Name
Onkoterápiás Intézet
Contact Person Name
Árpád Boronkai
Contact Person Email
arpad.boronkai@gmail.com
Site Name
Clinic Of Pulmonology Semmelweis University
Department Name
Pulmonológiai Klinika
Contact Person Name
Veronika Müller
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Onkológiai osztály
Contact Person Name
Yousuf Al-Farhat
Contact Person Email
yalfarhat@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
16-12-2024
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
351
Number Of Sites
23
Number Of Participants
70

Sites

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 Kassel GmbH
Department Name
Klinik für Haematologie Onkologie und Immunologie
Contact Person Name
Daniela Doerfel
Contact Person Email
daniela.doerfel@gnh.net
Site Name
Klinikum Region Hannover GmbH
Department Name
Klinik für Pneumologie, Intensiv- und Schlafmedizin
Contact Person Name
Thomas Fuehner
Contact Person Email
thomas.fuehner@krh.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik IV Organonkologie
Contact Person Name
Thomas Wehler
Site Name
Muehlenkreiskliniken AöR
Department Name
Klinik für Hämatologie, Onkologie Hämosaseologie und Palliativmedizin
Contact Person Name
Parvis Sadjadian
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Pneumologie und Infektiologie Lungenkrebszentrum
Contact Person Name
Heiko Golpon
Contact Person Email
golpon.heiko@mh-hannover.de
Site Name
Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack und Partner
Contact Person Name
Eckart Laack
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Contact Person Name
Akin Atmaca
Contact Person Email
atmaca.akin@khnw.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für innere Medizin II - Hämatologie und Onkologie
Contact Person Name
Matthias Ritgen
Contact Person Email
m.ritgen@med2.uni-kiel.de
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Onkologie Lungenkrebszentrum
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
Site Name
Klinikum Wuerzburg Mitte gGmbH
Department Name
Medizinische Klinik mit Schwerpunkt Pneumologie & Beatmungsmedizin
Contact Person Name
Jens Kern
Contact Person Email
jens.kern@kwm-klinikum.de
Site Name
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name
Onkologie und Palliativmedizin der Lungenklinik Hemer
Contact Person Name
Karsten Schulmann
Contact Person Email
karsten.schulmann@lkhemer.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Innere Medizin-Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Joerg-Christian Rath
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik fuer Kardiologie, Angiologie und Pneumologie
Contact Person Name
Martin Faehling
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin V- Pneumologie, Allergologie, Beatmungs- und Umweltmedizin
Contact Person Name
Jan Stratmann
Contact Person Email
jan.stratmann@uks.eu
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Innere Medizin II - Kardiologie, Pneumologie, Internitische Intensivmedizin - Pneumologie
Contact Person Name
Christian Schulz
Contact Person Email
christian.schulz@ukr.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Studienzentrum Thoraxonkologie
Contact Person Name
Farastuk Bozorgmehr
Site Name
HELIOS Klinikum Krefeld GmbH
Department Name
Lungenkrebszentrum
Contact Person Name
Benoit Kraemer-Relius
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Pneumologie und Pneumologische Onkologie
Contact Person Name
Konrad Kokowski
Site Name
Zentralklinik Bad Berka GmbH
Department Name
Klinik für Internistische Onkologie und Hämatologie
Contact Person Name
Mahmoud Mirza
Contact Person Email
Mahmoud.mirza@zentralklinik.de
Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name
Pneumologie
Contact Person Name
Christian Grohe
Contact Person Email
christian.grohe@jsd.de
Site Name
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name
Klinik für Lungen- & Bronchialheilkunde
Contact Person Name
Karl-Otto Kambartel
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Krankenhaus Köln-Merheim Lungenklinik Lungenkrebszentrum
Contact Person Name
Carolin Groß-Ophoff-Müller

Belgium

Earliest CTIS Part Ii Submission Date
02-12-2024
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
409
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Pneumology
Contact Person Name
Sofie Derijcke
Contact Person Email
sofie.derijcke@azgroeninge.be
Site Name
Clinique Saint-Pierre
Department Name
Pneumology
Contact Person Name
Luciano Carestia
Contact Person Email
luciano.carestia@cspo.be
Site Name
Grand Hopital De Charleroi
Department Name
Pneumology
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
Chirec
Department Name
Pneumology
Contact Person Name
Christophe Compère
Contact Person Email
christophe.compere@chirec.be

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 INFUSION
Route
Intravenous infusion
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation present (EU/1/15/1024/002) per product record
Maximum Dose
200 mg
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Maximum Dose
200 mg/m2
Investigational Product Name
Abraxane 5 mg/ml powder for dispersion for infusion.
Active Substance
PACLITAXEL ALBUMIN-BOUND
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation present (EU marketing numbers listed for product variants)
Maximum Dose
100 mg/m2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Maximum Dose
6 mg
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Maximum Dose
3 g
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Maximum Dose
5 mg/kg
Combination Treatment
Yes

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