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ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003)

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ClinicalTrials.gov Identifier: NCT05671510
Recruitment Status : Recruiting
First Posted : January 4, 2023
Last Update Posted : January 19, 2024
Sponsor:
Collaborator:
BioNTech SE
Information provided by (Responsible Party):
OncoC4, Inc.

Study Description
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Brief Summary:
The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Gotistobart Drug: Docetaxel Phase 3

Detailed Description:

This is a seamless 2-stage, randomized, open-label, active-controlled, Phase 3 study. The study population consists of patients with NSCLC who progressed on PD-1/PD-L1 inhibitor. Approximately 600 patients will be enrolled.

Two gotistobart dosing regimens will be tested in Stage I, and one will be selected for Stage II.

Stage I, the dose-confirmation stage, will assess the efficacy and safety of two gotistobart dosing regimens (3 mg/kg Q3W and 6 mg/kg Q3W with 2 loading doses of 10 mg/kg Q3W) in comparison to docetaxel 75 mg/m2 Q3W.

Stage II will assess the safety and efficacy of gotistobart at the selected dosing regimen versus docetaxel. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open-label, active controlled, multi-center Phase 3 study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors
Actual Study Start Date : June 28, 2023
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W
Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
 Drug: Gotistobart
Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.
Other Names:
  • A humanized anti-CTLA4 IgG1 monoclonal antibody
  • ONC-392
  • BNT316
Experimental: Arm 2: Gotistobart 3 mg/kg Q3W
Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
 Drug: Gotistobart
Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.
Other Names:
  • A humanized anti-CTLA4 IgG1 monoclonal antibody
  • ONC-392
  • BNT316
Active Comparator: Arm 3: Docetaxel 75 mg/m2, Q3W
Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
 Drug: Docetaxel
Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.
Other Names:
  • Docefrez
  • Taxotere


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 36 months ]
    OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 36 months ]
    Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1

  2. Progression-free survival (PFS) [ Time Frame: 36 months ]
    Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1

  3. Treatment emergent adverse events, treatment related adverse events and immune related adverse events. [ Time Frame: 36 months ]
    Incidence of TEAEs, TRAEs, irAEs will be calcuated. The AEs leading to treatment discontinuation will be recorded.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Major criteria):

  1. Adult (≥ 18 years), all genders, capable of signing informed consent.
  2. Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs.

  3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:

    1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;
    2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.

    Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed.

  4. At least one measurable tumor lesion according to RECIST 1.1.
  5. ECOG score of 0 or 1.
  6. Adequate organ functions. Serum LDH level ≤ 2xULN.
  7. Life expectancy ≥ 3 months.

Exclusion Criteria (Major criteria):

  1. Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.
  2. Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
  3. Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
  4. Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK;. Exception: KRAS mutations are not excluded.
  5. Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
  6. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
  7. Active interstitial lung disease (ILD) or non-infectious pneumonitis.
  8. Active infections with IV antibiotics within 14 days prior to first dose of study treatment.
  9. Impaired heart function.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05671510


Contacts
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Contact: Pan Zheng, MD, PhD 2027516823 pzheng@oncoc4.com
Contact: Martin Devenport, PhD 4102070582 mdevenport@oncoc4.com

Locations
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Sponsors and Collaborators
OncoC4, Inc.
BioNTech SE
Investigators
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Principal Investigator: Mark Socinski, MD Advent Health System
Principal Investigator: Tianhong Li, MD, PhD University of California, Davis
Principal Investigator: Kai He, MD, PhD Ohio State University
More Information
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Publications:

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Responsible Party: OncoC4, Inc.
ClinicalTrials.gov Identifier: NCT05671510    
Other Study ID Numbers: PRESERVE-003
First Posted: January 4, 2023    Key Record Dates
Last Update Posted: January 19, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action