PRESERVE-003: ONC-392 (Study Drug) Versus Docetaxel (Standard of Care) in Metastatic Non-small Cell Lung Cancer That Progressed on PD-1/PD-L1 Inhibitors (Immunotherapies)

Overview

Sponsor-declared trial summary

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]

Trial duration

21 Mar 2025 → ongoing

Decision date (initial)

2024-10-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

OncoC4, Inc. · BioNtech SE

External identifiers

EU CT number

2023-505311-20-01

ClinicalTrials.gov

NCT05671510

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Dose response, Safety, 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

Study design 1 period

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-003467-PIP01-23

Plan to share IPD

No

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 squamous 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 non-squamous histology type or 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

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oncoc4 Inc.

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

David Cerna

Public contact point

Organisation

Oncoc4 Inc.

Contact name

David Cerna

Third parties 13

Sponsor responsibilities

Article 77 compliance

Oncoc4 Inc.

Contact point sponsor

Oncoc4 Inc.

Article 77 implementation

Oncoc4 Inc.

Locations

5 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 92 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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