Clinical trial • Phase II • Oncology

PACLITAXEL for Non-small cell lung cancer (resectable, early-stage II–IIIB)

Phase II trial of PACLITAXEL for Non-small cell lung cancer (resectable, early-stage II–IIIB). Randomised, open-label. 493 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (resectable, early-stage II–IIIB)
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Bispecific antibody|ADC|Small molecule

Key dates

Initial CTIS Submission Date
29-08-2024
First CTIS Authorization Date
02-10-2024

Trial design

Randomised, open-label Phase II trial in Belgium, France, Hungary and others.

Randomised
Yes
Open Label
Yes
Biomarker Stratified
True, PD-L1 (strata: <1% vs ≥1% — PD-L1 <1% is an exclusion for Arms 6 and 7 when those arms are open)
Target Sample Size
493

Eligibility

Recruits 493 isVulnerablePopulationSelected = true. Country-specific informed consent and subject information documents are provided (country main ICFs and 'Other Pregnant Partner' ICFs). Adult participants provide written informed consent using country-specific ICFs (available in English, French, Dutch, Hungarian, Italian, Portuguese, Spanish per provided documents). No explicit assent procedures for minors are described in the available public documents..

Vulnerable Population
isVulnerablePopulationSelected = true. Country-specific informed consent and subject information documents are provided (country main ICFs and 'Other Pregnant Partner' ICFs). Adult participants provide written informed consent using country-specific ICFs (available in English, French, Dutch, Hungarian, Italian, Portuguese, Spanish per provided documents). No explicit assent procedures for minors are described in the available public documents.

Inclusion criteria

  • {"criterion_text":"-Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).\n-WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n-Adequate organ and bone marrow function.\n-Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.\n-Adequate pulmonary function."}

Exclusion criteria

  • {"criterion_text":"-Patients with: (a) sensitising EGFR mutations or ALK translocations.; (b) with baseline PD-L1 expression status < 1% (Arms 6 and 7 only);(i) Note: PD-L1 expression status < 1% only applies as an exclusion when Arms 6 or 7 are open to enrolment\n-QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.\n-Any medical contraindication to treatment with chemotherapy as listed in the local labelling.\n-Participants with moderate or severe cardiovascular disease.\n-Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.\n-Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.\n-Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.\n-Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.\n-Active or uncontrolled infections including HBA, HBV, HCV, and HIV.\n-Active or prior documented autoimmune or inflammatory disorders.\n-Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.\n-History of another primary malignancy.\n-Participants with small-cell lung cancer or mixed small-cell lung cancer.\n-History of active primary immunodeficiency.\n-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.\n-Participants who have preoperative radiotherapy treatment as part of their care plan.\n-Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-pCR is defined as lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes as determined by central BIPR and described by IASLC 2020. The measure of interest is the proportion of patients with 0% residual viable tumour cells within all resected tissue as assessed by the central blinded pathologist.","definition_or_measurement_approach":"pCR defined as absence of viable tumour cells in resected specimen and sampled regional lymph nodes per central BIPR and IASLC 2020; measured as proportion of patients with 0% residual viable tumour cells assessed by the central blinded pathologist."}
  • {"endpoint_text":"-Safety and tolerability will be evaluated in terms of AEs, vital signs, and clinical laboratory parameters.","definition_or_measurement_approach":"Safety/tolerability assessed by recording adverse events (AEs), monitoring vital signs, and clinical laboratory parameters."}

Secondary endpoints

  • {"endpoint_text":"-EFS is defined as the time from randomisation to the first of the following: local or distant disease recurrence, progressive disease that precludes surgery or prevents completion of surgery, or death due to any cause.","definition_or_measurement_approach":"EFS measured as time from randomisation to first event: local/distant recurrence, progression precluding/completing surgery, or death."}
  • {"endpoint_text":"-DFS is defined as the time from surgery until the first of the following: local or distant disease recurrence or date of death due to any cause.","definition_or_measurement_approach":"DFS measured as time from surgery to local/distant recurrence or death."}
  • {"endpoint_text":"-Feasibility to surgery is defined as having the planned surgical resection within 40 days from the end of the last dose of neoadjuvant study interventions. The measure of interest is the proportion of patients that have intended surgery within 40 days from the end of last dose of neoadjuvant study interventions.","definition_or_measurement_approach":"Proportion of patients undergoing planned surgical resection within 40 days of last neoadjuvant dose."}
  • {"endpoint_text":"-mPR is defined as ≤ 10% viable tumour cells in resected tumour after complete evaluation in the resected lung cancer specimen as determined by central BIPR as described by IASLC 2020. The measure of interest is the proportion of patients with ≤ 10% residual viable tumour cells within all resected tissue as assessed by the central blinded pathologist.","definition_or_measurement_approach":"mPR defined as ≤10% viable tumour cells in resected tumour per central BIPR/IASLC 2020; measured as proportion of patients with ≤10% residual viable tumour cells by central blinded pathologist."}
  • {"endpoint_text":"-ORR is defined as the proportion of patients who have a CR or PR as determined by Investigator using RECIST 1.1. Patients who go off therapy prior to surgery, without a response, receive a subsequent therapy prior to surgery, and then respond will not be included as responders in the ORR. The measure of interest is the proportion of patients with OR.","definition_or_measurement_approach":"ORR measured as proportion of patients with CR or PR per Investigator assessment using RECIST 1.1; specific rules exclude responses after off-therapy subsequent treatment prior to surgery."}
  • {"endpoint_text":"-OS is defined as the time from randomisation until the date of death due to any cause. The measure of interest is the landmark OS at 12 months and 24 months, and other clinically relevant timepoints if feasible. If reached by the end of the study, the median OS will also be of interest.","definition_or_measurement_approach":"OS measured as time from randomisation to death from any cause; landmarks at 12 and 24 months (and median OS if reached)."}
  • {"endpoint_text":"-Concentration of study interventions in plasma or serum.","definition_or_measurement_approach":"PK sampling to determine plasma/serum concentrations of study interventions."}
  • {"endpoint_text":"-Presence of ADA for study interventions.","definition_or_measurement_approach":"Immunogenicity testing to detect anti-drug antibodies (ADA) against study interventions."}
  • {"endpoint_text":"-Baseline PD-L1 expression.","definition_or_measurement_approach":"Assessment of baseline PD-L1 expression in tumour samples; used for exploratory analyses/associations with clinical endpoints."}
  • {"endpoint_text":"-ctDNA clearance on-treatment prior to surgery.","definition_or_measurement_approach":"Assessment of circulating tumour DNA clearance during neoadjuvant treatment prior to surgery in patients with evaluable ctDNA."}

Recruitment

Planned Sample Size
493
Recruitment Window Months
102
Consent Approach
Written informed consent obtained from adult participants using country-specific ICFs. Country ICF/Main Adult and Other Pregnant Partner ICFs are provided for multiple countries and languages (English, French, Dutch, Hungarian, Italian, Portuguese, Spanish). Optional research ICFs and subject materials (leaflets, participation cards) are available; consent procedures are handled per country documentation. No public information on assent procedures for minors was found.

Methods

  • Country-specific recruitment materials and procedures documented: recruitment procedure descriptions, brochures, posters, flip charts, patient factsheets and recruitment information (documents available for Belgium, France, Hungary, Ireland, Italy, Portugal, Spain). Materials are targeted to patients with resectable NSCLC and are country/language-specific (English, French, Dutch, Hungarian, Italian, Portuguese, Spanish).

Geography

Total Number Of Sites
50
Total Number Of Participants
493

Belgium

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
566
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
0503: Department of Pulmonary Disease
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be
Site Name
UZ Leuven
Department Name
0501: Pneumologie
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be
Site Name
Az Maria Middelares Gent
Department Name
0505: Pneumologie
Contact Person Name
Paul Germonpré
Contact Person Email
paul.germonpre@azmmsj.be
Site Name
AZ Sint-Lucas & Volkskliniek
Department Name
0504: longziekten
Contact Person Name
Elke Govaerts
Contact Person Email
Elke.Govaerts@Azstlucas.Be
Site Name
Grand Hopital De Charleroi
Department Name
0502: Oncologie - Hématologie
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be

France

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
570
Number Of Sites
7
Number Of Participants
153

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
2403:Service de Pneumologie, Oncologie Thoracique et Pneumologie Interventionnelle
Contact Person Name
Thomas Egenod
Contact Person Email
thomas.egenod@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
2405:Service de pneumologie, oncologie thoracique et soins intensifs respiratoires
Contact Person Name
Florian Guisier
Contact Person Email
florian.guisier@chu-rouen.fr
Site Name
Centre Hospitalier D Avignon
Department Name
2407:Service Onco-Hématologie
Contact Person Name
Nicolas Cloarec
Contact Person Email
cloarec.nicolas@ch-avignon.fr
Site Name
HIA Sainte Anne
Department Name
2406:Service de Pneumologie
Contact Person Name
Olivier Bylicki
Contact Person Email
bylicki.olivier@yahoo.fr
Site Name
Hospital Foch
Department Name
2404:Service d'Oncologie Medicale
Contact Person Name
Jaafar Bennouna
Contact Person Email
j.bennouna@hopital-foch.com
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
2401:Service d'Oncologie Medicale
Contact Person Name
Charlotte Domblides
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
2402:Service de Pneumologie
Contact Person Name
Romain Corre
Contact Person Email
romain.corre@ch-cornouaille.fr

Hungary

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
570
Number Of Sites
4
Number Of Participants
33

Sites

Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
3301:Onkoradiológiai Központ
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso.study@kmk.hu
Site Name
Reformatus Pulmonologiai Centrum
Department Name
3302:Onkológia, kúra - fekvőbeteg ellátás
Contact Person Name
Gabriella Gálffy
Contact Person Email
ggalffy@hotmail.com
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
3303:Pulmonológiai Osztály
Contact Person Name
Zsolt Pápai-Székely
Contact Person Email
zsoltpapai@yahoo.com
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
3304:Tüdőgyógyászati Osztály
Contact Person Name
Csaba Böcskei
Contact Person Email
csbocskei@gmail.com

Ireland

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
567
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Beaumont Hospital
Department Name
3904:Oncology
Contact Person Name
Jarushka Naidoo
Contact Person Email
jarushkanaidoo@beaumont.ie
Site Name
University Hospital Galway
Department Name
3901:Oncology
Contact Person Name
Silvie Blazkova
Contact Person Email
Silvie.Blazkova@hse.ie
Site Name
St James's Hospital
Department Name
3903:Haematology Oncology Daycare (HODC) Metabolic Research Unit
Contact Person Name
Patrick Forde
Contact Person Email
fordep1@tcd.ie
Site Name
Mater Misericordiae University Hospital
Department Name
3902:Clinical Trials Research Unit
Contact Person Name
Deirdre Kelly
Contact Person Email
deirdrekelly@mater.ie

Italy

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
566
Number Of Sites
12
Number Of Participants
144

Sites

Site Name
Istituto Oncologico Veneto
Department Name
4105:Oncologia Medica 2
Contact Person Name
Laura Bonanno
Contact Person Email
laura.bonanno@iov.veneto.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
4113:UO Oncologia Medica
Contact Person Name
Salvatore Grisanti
Contact Person Email
grisanti.salvatore@gmail.com
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
4107:UO Clinica di Oncologia Medica
Contact Person Name
Carlo Genova
Contact Person Email
carlo.genova@hsanmartino.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
4112:Dipartimento di Ematologia ed Oncologia
Contact Person Name
Giulio Cerea
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
4108:Dipartimento di Oncologia ed Ematologia clinica e sperimentale
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
4101:UOC Oncologia Medica 2
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
4103:Dipartimento Oncologia medica
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
University Hospital Of Perugia
Department Name
4106:SC Oncologia Medica
Contact Person Name
Giulio Metro
Contact Person Email
giulio.metro@yahoo.com
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
4102:SC Oncologia Medica
Contact Person Name
Diego Cortinovis
Site Name
Humanitas Mirasole S.p.A.
Department Name
4104:UO Oncologia Medica ed Ematologia
Contact Person Name
Luca Toschi
Contact Person Email
luca.toschi@humanitas.it
Site Name
Careggi University Hospital
Department Name
4110:UO Radioterapia
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
4109:Dipartimento Cardiotoraco vascolare
Contact Person Name
Antonio Chella
Contact Person Email
a.chella@outlook.it

Portugal

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
567
Number Of Sites
5
Number Of Participants
40

Sites

Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
5804:Oncologia
Contact Person Name
Mariana Sardinha
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
5805:Oncologia Medica
Contact Person Name
Marta Soares
Site Name
Hospital Da Luz S.A.
Department Name
5803:Oncologia
Contact Person Name
João Pinto
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
5807:Serviço de Pneumologia
Contact Person Name
Daniela Cardoso
Site Name
Champalimaud Clinical Centre
Department Name
5801:Oncologia
Contact Person Name
Susana Simões

Spain

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
570
Number Of Sites
13
Number Of Participants
106

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
7010:Oncología Médica
Contact Person Name
Alexandre Martínez Martí
Contact Person Email
amartinezmarti@vhio.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
7006:Oncología
Contact Person Name
Amelia Insa Mollá
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
7005:Oncología Médica
Contact Person Name
Carlos Aguado de la Rosa
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
7012:Oncología Médica
Contact Person Name
Manuel Dómine Gómez
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
7001:Oncología Médica
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
7002:Oncologia
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital General Universitario Dr. Balmis
Department Name
7013:Oncología
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
massuti.oncoalicante@gmail.com
Site Name
Salut Sant Joan De Reus
Department Name
7004:Oncología
Contact Person Name
Sergio Peralta Muñoz
Site Name
Hospital Clinic De Barcelona
Department Name
7011:Oncología Médica
Contact Person Name
Noemí Reguart Aransay
Contact Person Email
nreguart@clinic.cat
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
7008:Oncología Médica
Contact Person Name
David Vicente Baz
Contact Person Email
David.Vbaz@Gmail.Com
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
7003:Oncologia
Contact Person Name
Romà Bastús Piulats
Contact Person Email
rbastus@mutuaterrassa.es
Site Name
Hospital Universitario Reina Sofia
Department Name
7007:Oncología Médica
Contact Person Name
Isidoro Carlos Barneto Aranda
Contact Person Email
isidorobarnetoaranda@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
7009:Neumología
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Sponsor duties codes: 1,10,11,12,2,5,6,8,9; contact Clinicaltrial.Enquiries@parexel.com

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,2,5,6,8,9; contact Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
PEMETREXED
Active Substance
PEMETREXED DISODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Monalizumab
Active Substance
MONALIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Datopotamab deruxtecan
Active Substance
DATOPOTAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Oleclumab
Active Substance
OLECLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
volrustomig
Active Substance
VOLRUSTOMIG
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Rilvegostomig
Active Substance
RILVEGOSTOMIG
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
AZD0171
Active Substance
FALBIKITUG
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
IMFINZI (Durvalumab)
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Combination Treatment
Yes

Related trials

Other published trials that may interest you.