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

PHASE3RECRUITING

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.

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Study 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 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Adult (≥ 18 years), all genders, capable of signing informed consent.

Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs.

Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b: At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy; 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.

At least one measurable tumor lesion according to RECIST 1.1.

ECOG score of 0 or 1.

Adequate organ functions. Serum LDH level ≤ 2xULN.

Life expectancy ≥ 3 months.

Exclusion criteria

Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.

Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.

Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.

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.

Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.

Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.

Active interstitial lung disease (ILD) or non-infectious pneumonitis.

Active infections with IV antibiotics within 14 days prior to first dose of study treatment.

Impaired heart function.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-06-28

Primary completion: 2026-06-30

Study completion finish: 2027-06-30

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05671510

Intervention or treatment

DRUG: Gotistobart

DRUG: Docetaxel

Conditions

• Non Small Cell Lung Cancer

Image related to Non Small Cell Lung Cancer

Condition: Non Small Cell Lung Cancer
DRUG: Gotistobart and other drugs
Bankstown, New South Wales, Australia and more
Sponsor: OncoC4, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Bankstown Hospital - 3305

Research sites nearby

Select from list below to view details:

Bankstown Hospital - 3305
Bankstown, New South Wales, Australia
Newcastle Private Hospital - 3302
New Lambton Heights, New South Wales, Australia
Mater - 3301
Newstead, Queensland, Australia
Cancer Research SA - 3303
Adelaide, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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.
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.
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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Overall Survival (OS)	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.	36 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Objective response rate (ORR)	Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1	36 months
Progression-free survival (PFS)	Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1	36 months
Treatment emergent adverse events, treatment related adverse events and immune related adverse events.	Incidence of TEAEs, TRAEs, irAEs will be calcuated. The AEs leading to treatment discontinuation will be recorded.	36 months

Frequently Asked Questions

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References

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