Study Comparing ONC-392 and Docetaxel for Advanced Non-Small Cell Lung Cancer After PD-1/PD-L1 Treatment

Sponsor: OncoC4, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05671510

Provider View

This Phase 3 clinical trial is testing a new drug, gotistobart (ONC-392), against the chemotherapy drug docetaxel to see if it can help patients with advanced non-small cell lung cancer live longer after their cancer has progressed on previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called gotistobart (ONC-392) in patients with advanced non-small cell lung cancer (NSCLC) whose disease has worsened after treatment with PD-1/PD-L1 inhibitors. The trial will compare gotistobart to the chemotherapy drug docetaxel to see which one is better at prolonging life. Participants will be randomly assigned to receive either gotistobart or docetaxel through an IV infusion every 21 days, for up to 17 cycles over about a year.

Description

This clinical trial is divided into two stages and involves patients with advanced non-small cell lung cancer (NSCLC) that has progressed after treatment with PD-1/PD-L1 inhibitors. Around 600 patients will participate in the study.

In Stage I, researchers will test two different doses of gotistobart to determine which is more effective and safe. The doses being tested are 3 mg/kg and 6 mg/kg, both given every three weeks, with two initial higher doses of 10 mg/kg. These will be compared to the standard chemotherapy dose of docetaxel, which is 75 mg/m2 every three weeks.

In Stage II, the study will focus on the most effective dose of gotistobart identified in Stage I. Patients will be randomly assigned to receive either the selected dose of gotistobart or docetaxel, with the goal of determining which treatment is safer and more effective at extending life.

Eligibility Criteria

Inclusion Criteria (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.

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.

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