Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003)

2023-505311-20-00 Protocol PRESERVE-003 Therapeutic confirmatory (Phase III) Not authorised

Status Not authorised · 4 EU/EEA countries · 27 sites · Protocol PRESERVE-003

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Not authorised
Participants planned 575
Countries 4
Sites 27

Metastatic Non-Small Cell Lung Cancer

To assess the efficacy of ONC-392 vs. docetaxel as measured by overall survival (OS)

Key facts

Sponsor
Oncoc4 Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2023-12-11
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
OncoC4, Inc.

External identifiers

EU CT number
2023-505311-20-00
ClinicalTrials.gov
NCT05671510

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Safety, Others, Pharmacokinetic, Pharmacodynamic, Efficacy

To assess the efficacy of ONC-392 vs. docetaxel as measured by overall survival (OS)

Secondary objectives 3

  1. To assess the efficacy of ONC-392 vs. docetaxel by objective response rate (ORR) and progression-free survival (PFS)
  2. To assess safety and tolerability of ONC-392 vs. docetaxel
  3. Incidence of TEAEs, TRAEs, irAEs, and AEs leading to treatment discontinuation

Conditions and MedDRA coding

Metastatic Non-Small Cell Lung Cancer

VersionLevelCodeTermSystem organ class
21.1 PT 10059515 Non-small cell lung cancer metastatic 100000004864

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Phase 3,2-stage,Randomized Study of ONC-392 Vs Docetaxel in Metastatic Non-Small Cell Lung Cancers
This is a seamless 2-stage, randomized, open-label, active-controlled, Phase 3 study. The study population consists of patients with metastatic NSCLC who progressed on PD-1/PD-L1 inhibitor.
 Randomised Controlled None Stage 1 Arm 1: ONC-392 6 mg/kg Q3W with two loading doses of 10 mg/kg Q3W
Stage 1 Arm 2: ONC-392 3 mg/kg Q3W
Stage 1 Arm 3: Docetaxel 75 mg/m2 Q3W
Stage 2 Arm 1 or Arm 2: ONC-392 with the selected dosing regimen from Stage I
Stage 2 Arm 3: Docetaxel 75 mg/m2 Q3W

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Adult (≥ 18 years), all genders, capable of signing informed consent
  2. Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs
  3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b: a. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy; b. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy. Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed
  4. At least one measurable tumor lesion according to RECIST 1.1
  5. ECOG score of 0 or 1
  6. Adequate organ functions. Serum LDH level ≤ 2xULN
  7. Life expectancy ≥ 3 months

Exclusion criteria 9

  1. Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy
  2. Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment
  3. Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
  4. Having documented targetable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK. Exception: KRAS mutations are not excluded
  5. Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug
  6. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease
  7. Active interstitial lung disease (ILD) or noninfectious pneumonitis
  8. Uncontrolled fungal or viral infection. Active infections with IV antibiotics within 14 days prior to first dose of study treatment
  9. Impaired heart function

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Overall survival (OS)

Secondary endpoints 3

  1. Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
  2. Progression-free survival (PFS) as assessed by BICR per RECIST 1.1
  3. Incidence of TEAEs, TRAEs, irAEs, and AEs leading to treatment discontinuation.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

ONC-392

PRD10631077 · Product

Active substance
Humanised IGG1 Monoclonal Antibody Against CD152
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
10 mg/kg milligram(s)/kilogram
Max total dose
110 mg/kg milligram(s)/kilogram
Max treatment duration
52 Week(s)
Authorisation status
Not Authorised
MA holder
ONCOC4 INC.
Paediatric formulation
No
Orphan designation
No

Comparator 1

Docetaxel EVER Valinject 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD6727517 · Product

Active substance
Docetaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
CONCENTRATE FOR SOLUTION FOR INFUSION
Max daily dose
75 mg/m2 milligram(s)/sq. meter
Max total dose
1275 mg/m2 milligram(s)/sq. meter
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
L01CD02 — DOCETAXEL
Marketing authorisation
2200092.00.00
MA holder
EVER VALINJECT GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oncoc4 Inc.

2 Total trials 1 Recruiting
Commercial
Sponsor organisation
Oncoc4 Inc.
Address
9640 Medical Center Drive
City
Rockville
Postcode
20850-3368
Country
United States

Scientific contact point

Organisation
Oncoc4 Inc.
Contact name
Hung-Yen (Peter) Chou

Public contact point

Organisation
Oncoc4 Inc.
Contact name
Hung-Yen (Peter) Chou

Third parties 11

OrganisationCity, countryDuties
Edetek Inc.
ORG-100045957
 Princeton, United States Interactive response technologies (IRT), Data management, E-data capture
Pharmaceutical Product Development LLC
ORG-100016999
 Richmond, United States Other
Iqvia Biotech Limited
ORG-100008726
 Reading, United Kingdom Code 12
Wuxi Biologics (Shanghai) Co. Ltd.
ORG-100020899
 Shanghai, China Other
PPD International Holdings LLC
ORG-100007655
 Zaventem, Belgium Other
Wuxi Biologics Co. Ltd.
ORG-100018809
 Wuxi, China Other
Bioclinica Inc.
ORG-100033079
 Princeton, United States Other
Almac
ORG-100013160
 Souderton, United States Other
Joinn Laboratories(China)Co. Ltd.
ORG-100048339
 Beijing, China Laboratory analysis
Wuxi Biologics Biosafety Testing (Suzhou) Co. Ltd.
ORG-100023426
 Suzhou, China Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other

Locations

4 EU/EEA countries · 27 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Not authorised 15 4
Germany Not authorised 25 6
Italy Not authorised 40 11
Spain Not authorised 30 6
Rest of world
United States, China, Australia, Turkey, Korea, Republic of, Canada
 — 465 —

Investigational sites

Belgium

4 sites · Not authorised
Jessa Ziekenhuis
Pulmonology, Stadsomvaart 11, 3500, Hasselt
Centre Hospitalier Regional De La Citadelle
Pulmonology, Bld Du Douzieme-De-Ligne 1, 4000, Liege
Az Maria Middelares Gent
Pulmonology, Buitenring-Sint-Denijs 30, 9000, Gent
Vitaz
Pulmonology, Moerlandstraat 1, 9100, Sint-Niklaas

Germany

6 sites · Not authorised
KEM I Evang. Kliniken Essen-Mitte gGmbH
Oncology/Hematology, Henricistrasse 92, Huttrop, Essen
Muenchen Klinik gGmbH
Pneumologie und Pneumologische Onkologie, Englschalkinger Strasse 77, Bogenhausen, Munich
Lungenfachklinik Immenhausen
Lungenfachklinik Immenhausen Zentrum für Pneumologie, Robert-Koch-Straße 3, 34376, Immenhausen
Klinikverbund Allgaeu gGmbH
Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin, Robert Weixler Strasse 50, 87439, Kempten (Allgau)
Asklepios Fachkliniken Muenchen Gauting
Thoracic Oncology, Robert-Koch-Allee 2, 82131, Gauting
Klinikum Esslingen GmbH
Cardiology, Angiology, Pneumology, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar

Italy

11 sites · Not authorised
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOC Oncologia Medica, Via Del Vespro 129, 90127, Palermo
Istituto Tumori Bari Giovanni Paolo II
Oncologia Medica per Patologia Toracica, Viale Orazio Flacco 65, 70124, Bari
Azienda Ospedaliera Universitaria Federico II Di Napoli
Medicina e Chirurgia Clinica, Via Sergio Pansini 5, 80131, Naples
Fondazione IRCCS San Gerardo Dei Tintori
UOC Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Fondazione IRCCS Istituto Nazionale Dei Tumori
SS Oncologia Medica Toraco Polmonare, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Campus Bio-Medico
UOC Oncologia Medica, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliero Universitaria Delle Marche
Medicina Interna, SOD Clinica Oncologica, Via Conca 71, 60126, Ancona
Azienda Ospedaliera Papardo
Oncologia Medica, Viale Ferdinando Stagno D'alcontres Contrada Papardo, 98158, Messina
Azienda Sanitaria Territoriale Di Pesaro E Urbino
UOC Oncologia, OncoEmatologia, Piazzale Carlo Cinelli N 4, 61121, Pesaro
Ospedale San Raffaele S.r.l.
Unità di Oncologia Medica, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Papa Giovanni XXIII
Oncologia, Piazza Oms 1, 24127, Bergamo

Spain

6 sites · Not authorised
Hospital General Universitario De Elche
Medical Oncology Service, Edificio 2, Camino De La Almazara 11, Elche
Fundacion Instituto Valenciano De Oncologia
Medical Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Lucus Augusti
Medical Oncology Department, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital General Universitario De Valencia
Medical Oncology Department, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital General Universitario Gregorio Maranon
Medical Oncology Department, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Regional De Malaga
Medical Oncology Department, Avenida De Carlos De Haya Sn, 29010, Malaga

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-08-14 Spain Not acceptable
2023-12-04
 2023-12-04

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