733 Participants Needed

ONC-392 + Pembrolizumab for Non-Small Cell Lung Cancer

(PRESERVE-001 Trial)

Recruiting at 40 trial locations
PZ
MD
Overseen ByMartin Devenport, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ONC-392, an antibody that helps the immune system fight cancer, in patients with advanced or spreading tumors who haven't responded to other treatments. It works by blocking a protein that usually keeps immune responses in check, making it easier for the body to attack cancer cells.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of 21 days for cancer therapeutic drugs and 28 days for antibody drugs. If you are on chronic systemic steroid therapy at doses greater than 10 mg/day, you may not be eligible to participate.

What safety information is available for ONC-392 and Pembrolizumab in humans?

Pembrolizumab (also known as Keytruda) has been used in various clinical trials and is generally considered safe, but it can cause side effects like fatigue, cough, nausea, and more serious immune-related issues such as pneumonitis (lung inflammation). These side effects have been observed in patients with different types of cancer, including lung cancer and melanoma.12345

How is the drug ONC-392 + Pembrolizumab unique for treating non-small cell lung cancer?

The combination of ONC-392 and Pembrolizumab is unique because it pairs a novel agent, ONC-392, with Pembrolizumab, an established immune checkpoint inhibitor that blocks the PD-1 pathway, potentially enhancing the immune system's ability to fight cancer cells in non-small cell lung cancer.46789

What data supports the effectiveness of the drug ONC-392 + Pembrolizumab for Non-Small Cell Lung Cancer?

Research shows that pembrolizumab, a part of the treatment, has been effective in improving survival rates for patients with advanced non-small cell lung cancer, especially those with high levels of a protein called PD-L1. This suggests that the combination with ONC-392 could also be promising.46101112

Who Is on the Research Team?

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

Tianhong Li

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

Adults over 18 with certain advanced solid tumors or NSCLC, who have measurable disease and are in good physical condition. They must not be on high-dose steroids, pregnant, breastfeeding, or have brain metastases. Participants need functioning organs and agree to use contraception.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
I have an advanced cancer type that is treated with Pembrolizumab.
I am a woman who can have children and my pregnancy test is negative.
See 9 more

Exclusion Criteria

I am on long-term steroid treatment with doses over 10 mg/day.
I have active brain or spinal cord cancer symptoms.
Patients who have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Finding Phase I (Part A)

ONC-392 is administered as a single agent to determine the recommended Phase II dose for monotherapy

21 days
Every 21 days (Q3W)

Combination Therapy Phase (Part B)

ONC-392 is administered in combination with pembrolizumab to determine the recommended Phase II dose for combination therapy

21 days
Every 21 days (Q3W)

Expansion Cohorts (Part C)

Further assessment of safety and efficacy of ONC-392 in various cancer cohorts

Varies by cohort

Phase II Study (Part D)

ONC-392 monotherapy in recurrent and/or metastatic adenoid cystic carcinoma

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • ONC-392
  • Pembrolizumab
Trial Overview The trial is testing ONC-392 alone and combined with Pembrolizumab in patients with various cancers including NSCLC. It's a first-in-human study assessing safety, how the body processes the drug (pharmacokinetics), and effectiveness.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: ONC-392 in combination with pembrolizumabExperimental Treatment2 Interventions
Group II: ONC-392 and docetaxelExperimental Treatment2 Interventions
Group III: ONC-392 Treatment as single agentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

OncoC4, Inc.

Lead Sponsor

Trials
8
Recruited
1,800+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
In a study of 3,877 patients with advanced non-small-cell lung cancer (NSCLC) receiving pembrolizumab monotherapy, those who met eligibility criteria had significantly better overall survival (OS) compared to ineligible patients, with median OS of 16.3 months for eligible patients versus 8.2 months for ineligible patients.
The findings suggest that using an augmented population approach, which combines eligible and unknown patients, can enhance the analysis of real-world data, showing similar survival profiles and characteristics among these groups.
Augmenting Real-World Data Through Modeling Key Clinical Trial Eligibility Criteria: An Example of Patients With Non-small-Cell Lung Cancer Treated With Pembrolizumab.Jemielita, T., Li, XN., Burke, T., et al.[2021]
In a study of 566 patients with metastatic non-small cell lung cancer (NSCLC) treated with first-line pembrolizumab, the median overall survival was 19.6 months, with 3-year survival rates of 36.2%, indicating promising long-term outcomes in a real-world setting.
The study found that 38.6% of patients experienced a real-world tumor response, with the most common reasons for discontinuation of treatment being disease progression and therapy-related adverse effects, highlighting the treatment's efficacy and safety profile.
Long-Term Real-World Outcomes of First-Line Pembrolizumab Monotherapy for Metastatic Non-Small Cell Lung Cancer With ≥50% Expression of Programmed Cell Death-Ligand 1.Velcheti, V., Hu, X., Yang, L., et al.[2022]

Citations

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Augmenting Real-World Data Through Modeling Key Clinical Trial Eligibility Criteria: An Example of Patients With Non-small-Cell Lung Cancer Treated With Pembrolizumab. [2021]
Long-Term Real-World Outcomes of First-Line Pembrolizumab Monotherapy for Metastatic Non-Small Cell Lung Cancer With ≥50% Expression of Programmed Cell Death-Ligand 1. [2022]
Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater. [2022]
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC. [2021]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Characterization of the tumor immune-microenvironment of adenocarcinoma of lung with a metastatic lesion in the pancreas treated successfully with first-line, single-agent pembrolizumab. [2023]
Pembrolizumab for the treatment of PD-L1 positive advanced or metastatic non-small cell lung cancer. [2020]
Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50. [2020]
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