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

Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!

a study on Lung Cancer Non-Small Cell Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around
Principal Investigator
by Tianhong Li, MD, PhD

Description

Summary

The goal of this Phase 3 clinical trial is to 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.

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

Details

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 630 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 on squamous cell NSCLC. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.

Keywords

Non Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, Docetaxel, Gotistobart, Docetaxel 75 mg/m2, Q3W

Eligibility

You can join if…

Open to people ages 18 years and up

(Major criteria):

  1. Adult (≥ 18 years), all genders, capable of signing informed consent.
  2. Histologically- or cytologically- confirmed diagnosis of metastatic squamous 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.

You CAN'T join if...

(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.

Locations

  • UC Davis Comprehensive Cancer Center - 1103 accepting new patients
    Sacramento California 95817 United States
  • Bass Medical Group - 1155 accepting new patients
    Walnut Creek California 94598 United States

Lead Scientist at UC Davis

  • Tianhong Li, MD, PhD
    Professor, MED: Int Med Hematology/Oncology, School of Medicine. Authored (or co-authored) 70 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
OncoC4, Inc.
Links
Sign up for this study
ID
NCT05671510
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 630 study participants
Last Updated
Contact us about this trial