Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

Conditions

• Adult Solid Tumor
• Metastatic Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Visugromab RDE (recommended dose for expansion) — BIOLOGICAL
  Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Visugromab 6mg/kg — BIOLOGICAL
  Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Nivolumab — BIOLOGICAL
  Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Placebo Saline Infusion — OTHER
  Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Docetaxel — DRUG
  Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Study Details

This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

Key Dates

Start date

Oct 7, 2025

Status verified

Jun 2026

Primary completion

Oct 1, 2029

Completion

Oct 1, 2031

Study Design

Enrollment

131 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Visugromab (RDE) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)
• Experimental: Arm B
  Visugromab (6mg/kg) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)
• Experimental: Arm C
  Visugromab (RDE) + Nivolumab (360 mg) + Placebo (Saline) intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)
• Active Comparator: Arm D
  Double Placebo (Saline) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 36 months ]

Central Contacts

• Lena Lemke, MD
  +49 89 200066440
  [email protected]

Locations (4)

Find similar trials in Birmingham, AL

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