600 Participants Needed

ONC-392 vs Chemotherapy for Lung Cancer

(PRESERVE-003 Trial)

Recruiting at 239 trial locations
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SS
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FK
TG
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Overseen ByBo Wang, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on systemic steroid therapy with more than 10 mg/day prednisone or equivalent within 7 days before starting the study treatment.

Is Gotistobart (Docetaxel) generally safe for humans?

Docetaxel, also known as Gotistobart, has been used in various cancer treatments and is generally considered safe, though it can cause side effects like neutropenia (low white blood cell count) and fluid retention. These side effects are usually manageable with medications and monitoring.12345

What makes the drug Gotistobart (Docetaxel) unique for lung cancer treatment?

Gotistobart, also known as Docetaxel, is unique because it is a semisynthetic taxane that has shown effectiveness in treating advanced non-small cell lung cancer, both as a single agent and in combination with other therapies. It is particularly noted for its ability to improve quality of life and modestly extend survival in patients who have not responded to other chemotherapy treatments.678910

What data supports the effectiveness of the drug Gotistobart for lung cancer?

Research shows that docetaxel, a component of Gotistobart, is effective in treating advanced non-small cell lung cancer, improving survival and quality of life for patients who have not responded to other chemotherapy treatments.79101112

Who Is on the Research Team?

Mark A. Socinski | AdventHealth Cancer ...

Mark Socinski, MD

Principal Investigator

Advent Health System

Tianhong Li, M.D., Ph.D. for UC Davis ...

Tianhong Li

Principal Investigator

University of California, Davis

Dr. Kai He - Medical Oncology ...

Kai He, MD, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs
My cancer has worsened after my last treatment.
At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy
See 6 more

Exclusion Criteria

Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
I last received anti-PD-1/PD-L1 treatment less than 28 days ago.
I have not taken more than 10 mg/day of steroids like prednisone in the last week.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage I

Dose-confirmation stage assessing efficacy and safety of two gotistobart dosing regimens compared to docetaxel

21 weeks
1 visit every 3 weeks (in-person)

Treatment Stage II

Assessment of safety and efficacy of selected gotistobart dosing regimen versus docetaxel

21 weeks
1 visit every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Docetaxel
  • ONC-392
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Gotistobart 3 mg/kg Q3WExperimental Treatment1 Intervention
Group II: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3WExperimental Treatment1 Intervention
Group III: Arm 3: Docetaxel 75 mg/m2, Q3WActive Control1 Intervention

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Taxotere for:
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Approved in European Union as Taxotere for:
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Approved in Canada as Taxotere for:
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Approved in Japan as Taxotere for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

OncoC4, Inc.

Lead Sponsor

Trials
8
Recruited
1,800+

BioNTech SE

Industry Sponsor

Trials
84
Recruited
120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Published Research Related to This Trial

Docetaxel has been shown to improve quality of life and provide a modest prolongation of survival in patients with recurrent or metastatic non-small-cell lung cancer (NSCLC).
Randomized trials indicate that single-agent docetaxel is more effective than best supportive care for advanced NSCLC, benefiting both untreated patients and those who have previously undergone cisplatin-based chemotherapy.
Single-agent docetaxel (Taxotere) in the treatment of advanced non small-cell lung cancer: clinical concepts and commentary.Laurie, SA., Kris, MG.[2019]
Docetaxel has been established as the preferred treatment for advanced non-small cell lung cancer that does not respond to initial chemotherapy, based on the results of two recent trials.
Ongoing trials are exploring the use of docetaxel not only as a primary treatment but also in combination with radiation therapy, indicating its potential versatility in cancer treatment.
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update.Kris, MG., Manegold, C.[2019]
Docetaxel has been established as the preferred treatment for advanced non-small cell lung cancer that does not respond to initial chemotherapy, based on the results of two recent trials.
Ongoing trials are exploring the use of docetaxel not only as a primary treatment but also in combination with radiation therapy, indicating its potential versatility in cancer treatment.
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: An international update.Kris, MG., Manegold, C.[2019]

Citations

Single-agent docetaxel (Taxotere) in the treatment of advanced non small-cell lung cancer: clinical concepts and commentary. [2019]
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update. [2019]
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: An international update. [2019]
Taxanes for advanced non-small cell lung cancer. [2019]
Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. [2023]
Summary of phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of advanced non-small cell lung cancer. [2018]
Docetaxel in non-small cell lung cancer: a review. [2019]
[Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology]. [2018]
A multicenter phase II study of docetaxel and carboplatin combination as front-line treatment in advanced non-small cell lung cancer. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer. [2018]
Docetaxel (Taxotere) in combination chemotherapy and in association with thoracic radiotherapy for the treatment of non-small-cell lung cancer. Thoracic Oncology Program. [2022]
Taxanes as first-line therapy for advanced non-small cell lung cancer: a systematic review and practice guideline. [2022]
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