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Anti-tumor antibiotic

ONC-392 vs Chemotherapy for Lung Cancer (PRESERVE-003 Trial)

Verified Trial
Phase 3
Recruiting
Led By Mark Socinski, MD
Research Sponsored by OncoC4, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs
Life expectancy ≥ 3 months
Must not have
Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
Impaired heart function.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing gotistobart, a new drug that helps the immune system fight advanced lung cancer in patients who haven't responded to other treatments. It works by blocking a protein that allows cancer cells to hide from the immune system.

Who is the study for?
This trial is for adults with metastatic non-small cell lung cancer (NSCLC) who have already tried PD-1/PD-L1 inhibitors and chemotherapy. Patients whose disease has worsened after treatment are eligible to participate.
What is being tested?
The study compares ONC-392, a new anti-CTLA-4 antibody, against docetaxel, a chemotherapy drug. The purpose of this study is to determine whether the study drug, ONC-392, is safe and well tolerated. The study will also test whether ONC-392 is effective in treating non-small call lung cancer, in comparison with the chemotherapy standard of care drug, docetaxel.
What are the potential side effects?
Common risks associated with ONC-392 include loose or watery stools (diarrhea or colitis), nausea/vomiting, skin rash or dry skin or itchy skin, fatigue or tiredness, cough, headache, back pain, or pain in your belly. Common risks associated with docetaxel include: skin reactions, neurological reactions, eye disorders, physical weakness, and tumor lysis syndrome.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Secondary study objectives
Objective response rate (ORR)
Progression-free survival (PFS)
Treatment emergent adverse events, treatment related adverse events and immune related adverse events.

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Gotistobart 3 mg/kg Q3WExperimental Treatment1 Intervention
Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Group II: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3WExperimental Treatment1 Intervention
Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Group III: Arm 3: Docetaxel 75 mg/m2, Q3WActive Control1 Intervention
Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days .

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapies and chemotherapies. Immunotherapies, such as anti-CTLA-4 antibodies (e.g., Gotistobart) and anti-PD-1/PD-L1 antibodies (e.g., nivolumab, pembrolizumab), work by blocking immune checkpoints, thereby enhancing the immune system's ability to attack cancer cells. Chemotherapies like docetaxel disrupt cell division, leading to cancer cell death. Understanding these mechanisms is vital for NSCLC patients to choose the most effective treatment tailored to their specific cancer type and health condition.
Unexpected long survival of brain oligometastatic non-small cell lung cancer (NSCLC) treated with multimodal treatment: a single-center experience and review of the literature.Customizing chemotherapy in non-small cell lung cancer: the promise is still unmet.

Find a Location

Who is running the clinical trial?

OncoC4, Inc.Lead Sponsor
7 Previous Clinical Trials
1,187 Total Patients Enrolled
BioNTech SEIndustry Sponsor
71 Previous Clinical Trials
110,519 Total Patients Enrolled
Mark Socinski, MDPrincipal InvestigatorAdvent Health System
2 Previous Clinical Trials
698 Total Patients Enrolled
~317 spots leftby Jun 2026