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

ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncoC4, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gotistobart

    Drug

    Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.

  • Docetaxel

    Drug

    Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.

Treatment groups

630 Participants
are divided into 2 treatment groups
Group A: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3WExperimental treatment 1 intervention
Group B: Arm 2: Docetaxel 75 mg/m2, Q3WActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
36 months

Secondary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) as assessed by the Investigator per RECIST 1.1

Time frame
36 months
2

Progression-free survival (PFS)

Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1

Time frame
36 months
3

Treatment emergent adverse events, treatment related adverse events and immune related adverse events.

Incidence of TEAEs, TRAEs, irAEs will be calculated. The AEs leading to treatment discontinuation will be recorded.

Time frame
36 months

Other outcomes

Sponsors and contacts

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OncoC4, Inc.

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov
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