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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
Do you have normal organ function?
Can you perform your normal daily routine without any major restrictions?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

PRESERVE-003 Trial Summary

The study will test if ONC-392 is safe and well tolerated. It will also evaluate whether ONC-392 is effective in treating non-small cell lung cancer in comparison with the chemotherapy standard of care drug docetaxel.

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. Check my eligibility
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.See study design
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.

PRESERVE-003 Trial Eligibility Criteria

Inclusion Criteria

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

PRESERVE-003 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
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%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
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

PRESERVE-003 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 .

Find a Location

Who is running the clinical trial?

OncoC4, Inc.Lead Sponsor
6 Previous Clinical Trials
1,164 Total Patients Enrolled
BioNTech SEIndustry Sponsor
64 Previous Clinical Trials
107,098 Total Patients Enrolled
Mark Socinski, MDPrincipal InvestigatorAdvent Health System
2 Previous Clinical Trials
696 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the costs to participants?

"There will be no additional cost to you for taking part in this study. You will be provided with all ONC-392, examinations, and medical care related to the study without charge. Medications, assessments, and procedures that are part of the standard of care for your condition may not be covered by the study, including docetaxel. "

Verified Answer

What if I require support for travel and accommodation to participate in the study?

"You may be eligible for assistance with costs associated with travel for purposes of research participation. "

Verified Answer

Can I participate in this clinical trial while receiving other treatments?

"No, if you participate in this trial you may not receive any other treatment for your cancer as long as you are on the trial."

Verified Answer

Can I leave this clinical trial if I change my mind or experience side effects?

"Yes you can leave a clinical trial at any time."

Verified Answer

Will I know what medication I'm taking?

"Yes, your doctor or the study staff will tell you which medication you are receiving - either ONC-392 or docetaxel."

Verified Answer

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Cancer Care Associates of York, Inc.
Astera Cancer Care
University of Tennessee Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Lung tumors, bronchiectasis, COPD,.. I’ve had this tinnitus for 15 years and nothing has worked.
PatientReceived 1 prior treatment
I applied to improve my health and to contribute to medical science. Im diagosted whit pancreatic cancer and longs i dont hav insurance please if you hav any chance contact me thanks 562-965-9713.
PatientReceived 2+ prior treatments
I've had 4 chemo infusion treatments and now the cancer has spread to the right lung, I have talked to the Doctors about other options they don't what to hear that. Now we know the chemo didn't work, I'm worst now than before.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Hematology Oncology Clinic/SCRI: < 24 hours
  2. Texas Oncology - San Antonio Northeast (USOR): < 24 hours
  3. SCRI - Tennessee Oncology: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
Cell ResearchJournal
Hijacking Antibody-induced CTLA-4 Lysosomal Degradation for Safer and More Effective Cancer Immunotherapy
Zhang, Yan, Xuexiang Du, Mingyue Liu, Fei Tang, Peng Zhang, Chunxia Ai, James K. Fields, et al.. 2019. “Hijacking Antibody-induced CTLA-4 Lysosomal Degradation for Safer and More Effective Cancer Immunotherapy”. Cell Research. Springer Science and Business Media LLC. doi:10.1038/s41422-019-0184-1.
clinicaltrials.govStudy
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
2023. "ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05671510.
All > Lung Cancer Dallas > Montreal
~400 spots leftby Jun 2026
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