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

Conditions

• Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jun 28, 2023

Status verified

Apr 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

630 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• Active Comparator: Arm 2: 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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 36 months ]

Central Contacts

• Pan Zheng, MD, PhD
  2027516823
  [email protected]

Locations (46)

Find similar trials in Dothan, AL

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