Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05671510




Registration number
NCT05671510
Ethics application status
Date submitted
26/12/2022
Date registered
4/01/2023
Date last updated
10/05/2024

Titles & IDs
Public title
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
Scientific title
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
Secondary ID [1] 0 0
PRESERVE-003
Universal Trial Number (UTN)
Trial acronym
PRESERVE-003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gotistobart
Treatment: Drugs - Docetaxel

Experimental: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W - Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.

Experimental: Arm 2: Gotistobart 3 mg/kg Q3W - Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.

Active Comparator: Arm 3: Docetaxel 75 mg/m2, Q3W - Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.


Treatment: Drugs: Gotistobart
Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.

Treatment: Drugs: Docetaxel
Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Treatment emergent adverse events, treatment related adverse events and immune related adverse events.
Timepoint [3] 0 0
36 months

Eligibility
Key inclusion criteria
Inclusion Criteria (Major criteria):

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:

1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based
chemotherapy;

2. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria (Major criteria):

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 actionable 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 non-infectious pneumonitis.

8. Active infections with IV antibiotics within 14 days prior to first dose of study
treatment.

9. Impaired heart function.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Bankstown Hospital - 3305 - Bankstown
Recruitment hospital [2] 0 0
Newcastle Private Hospital - 3302 - New Lambton Heights
Recruitment hospital [3] 0 0
Mater - 3301 - Newstead
Recruitment hospital [4] 0 0
Cancer Research SA - 3303 - Adelaide
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
- New Lambton Heights
Recruitment postcode(s) [3] 0 0
4006 - Newstead
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Hasselt
Country [25] 0 0
Belgium
State/province [25] 0 0
Liège
Country [26] 0 0
Belgium
State/province [26] 0 0
Sint-Niklaas
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Saskatchewan
Country [29] 0 0
Canada
State/province [29] 0 0
Québec
Country [30] 0 0
China
State/province [30] 0 0
Anhui
Country [31] 0 0
China
State/province [31] 0 0
Beijing
Country [32] 0 0
China
State/province [32] 0 0
Fujian
Country [33] 0 0
China
State/province [33] 0 0
Guangdong
Country [34] 0 0
China
State/province [34] 0 0
Guangxi
Country [35] 0 0
China
State/province [35] 0 0
Hainan
Country [36] 0 0
China
State/province [36] 0 0
Hebei
Country [37] 0 0
China
State/province [37] 0 0
Heilongjiang
Country [38] 0 0
China
State/province [38] 0 0
Henan
Country [39] 0 0
China
State/province [39] 0 0
Hubei
Country [40] 0 0
China
State/province [40] 0 0
Hunan
Country [41] 0 0
China
State/province [41] 0 0
Jiangsu
Country [42] 0 0
China
State/province [42] 0 0
Jiangxi
Country [43] 0 0
China
State/province [43] 0 0
Shandong
Country [44] 0 0
China
State/province [44] 0 0
Shanxi
Country [45] 0 0
China
State/province [45] 0 0
Sichuan
Country [46] 0 0
China
State/province [46] 0 0
Tianjin
Country [47] 0 0
China
State/province [47] 0 0
Yunnan
Country [48] 0 0
China
State/province [48] 0 0
Zhejiang
Country [49] 0 0
China
State/province [49] 0 0
Chengdu
Country [50] 0 0
China
State/province [50] 0 0
Jiangse
Country [51] 0 0
China
State/province [51] 0 0
Shanghai
Country [52] 0 0
China
State/province [52] 0 0
Wuhan
Country [53] 0 0
France
State/province [53] 0 0
Billancourt
Country [54] 0 0
France
State/province [54] 0 0
Créteil
Country [55] 0 0
France
State/province [55] 0 0
Limoges
Country [56] 0 0
Germany
State/province [56] 0 0
Bogenhausen
Country [57] 0 0
Germany
State/province [57] 0 0
Essen
Country [58] 0 0
Germany
State/province [58] 0 0
Esslingen am Neckar
Country [59] 0 0
Germany
State/province [59] 0 0
Immenhausen
Country [60] 0 0
Germany
State/province [60] 0 0
Immenstädt
Country [61] 0 0
Germany
State/province [61] 0 0
Muenchen-Gauting
Country [62] 0 0
Italy
State/province [62] 0 0
Ancona
Country [63] 0 0
Italy
State/province [63] 0 0
Bari
Country [64] 0 0
Italy
State/province [64] 0 0
Bergamo
Country [65] 0 0
Italy
State/province [65] 0 0
Messina
Country [66] 0 0
Italy
State/province [66] 0 0
Milano
Country [67] 0 0
Italy
State/province [67] 0 0
Monza
Country [68] 0 0
Italy
State/province [68] 0 0
Naples
Country [69] 0 0
Italy
State/province [69] 0 0
Palermo
Country [70] 0 0
Italy
State/province [70] 0 0
Perugia
Country [71] 0 0
Italy
State/province [71] 0 0
Roma
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Cheongju-si
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Daegu
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Goyang-si
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seoul
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Suwon
Country [77] 0 0
Netherlands
State/province [77] 0 0
Amsterdam
Country [78] 0 0
Netherlands
State/province [78] 0 0
Arnhem
Country [79] 0 0
Netherlands
State/province [79] 0 0
Herzogenbusch
Country [80] 0 0
Netherlands
State/province [80] 0 0
Tilburg
Country [81] 0 0
Spain
State/province [81] 0 0
Elche
Country [82] 0 0
Spain
State/province [82] 0 0
Lugo
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Málaga
Country [85] 0 0
Spain
State/province [85] 0 0
Valencia
Country [86] 0 0
Turkey
State/province [86] 0 0
Adana
Country [87] 0 0
Turkey
State/province [87] 0 0
Ankara
Country [88] 0 0
Turkey
State/province [88] 0 0
Antalya
Country [89] 0 0
Turkey
State/province [89] 0 0
Bornova
Country [90] 0 0
Turkey
State/province [90] 0 0
Edirne
Country [91] 0 0
Turkey
State/province [91] 0 0
Fatih
Country [92] 0 0
Turkey
State/province [92] 0 0
Istanbul
Country [93] 0 0
Turkey
State/province [93] 0 0
Izmir
Country [94] 0 0
United Kingdom
State/province [94] 0 0
England
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OncoC4, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
BioNTech SE
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen
anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small
cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The
study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could
prolong the life for NSCLC patients. Patients will be randomized to be treated with either
gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in
approximately one year.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05671510
Trial related presentations / publications
Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2.
Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10.
Public notes

Contacts
Principal investigator
Name 0 0
Mark Socinski, MD
Address 0 0
Advent Health System
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pan Zheng, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
2027516823
Fax 0 0
Email 0 0
pzheng@oncoc4.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05671510