What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and chemotherapy agents. Immune checkpoint inhibitors, such as anti-PD-1/PD-L1 antibodies (e.g., pembrolizumab, atezolizumab), can cause immune-related adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy agents like docetaxel are associated with side effects such as myelosuppression, neuropathy, alopecia, and gastrointestinal symptoms. Both treatment types require careful monitoring due to the potential for severe adverse events.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of NSCLC. Pembrolizumab (Keytruda) has been approved for use in combination with chemotherapy for both squamous and nonsquamous NSCLC, showing significant improvements in overall survival (OS) and progression-free survival (PFS). Atezolizumab (Tecentriq) combined with bevacizumab and chemotherapy has also been approved for nonsquamous NSCLC, demonstrating improved OS and PFS. Nivolumab (Opdivo) is another PD-1 inhibitor approved for previously treated advanced NSCLC. These treatments highlight the efficacy of immune checkpoint inhibitors in managing NSCLC, similar to the investigational anti-CTLA-4 antibody Gotistobart.

What other types of research exist?

Promising novel alternatives to Gotistobart for NSCLC patients include Telisotuzumab Vedotin, an antibody-drug conjugate targeting c-MET, and Alectinib, an ALK inhibitor. Telisotuzumab Vedotin has shown efficacy in c-MET-positive squamous cell carcinoma, while Alectinib has demonstrated durable responses in ALK-positive tumors.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

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 .

0 / 9Eligibility criteria met

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.

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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

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