A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Hoffmann-La Roche
Study ID
NCT05775289
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tobemstomig — DRUG
    Participants will receive intravenous (IV) tobemstomig for four 21-day cycles
  • Pembrolizumab — DRUG
    Participants will receive IV pembrolizumab four 21-day cycles
  • Paclitaxel — DRUG
    Participants will receive IV paclitaxel Q3W for four 21-day cycles
  • Pemetrexed — DRUG
    Participants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity
  • Carboplatin — DRUG
    Participants will receive IV carboplatin Q3W for four 21-day cycles

Study Details

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy.

Key Dates

Start date
Mar 15, 2023
Status verified
May 2026
Primary completion
Jun 20, 2024
Completion
Jun 1, 2026

Study Design

Enrollment
182 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Tobemstomig + Platinum-Based Chemotherapy
    Participants with non-squamous (NSQ) NSCLC will receive induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks (Q3W) for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig together with pemetrexed until disease progression or treatment discontinuation. Participants with squamous (SQ) NSCLC will receive blinded tobemstomig in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21 day cycles, followed by blinded tobemstomig (on Day 1) Q3W until disease progression or treatment discontinuation.
  • Active Comparator: Arm B: Pembrolizumab + Platinum-Based Chemotherapy
    Participants with NSQ NSCLC will receive induction treatment with blinded pembrolizumab in combination with pemetrexed and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by a maintenance therapy with blinded pembrolizumab together with pemetrexed Q3W until disease progression or treatment discontinuation. Participants with SQ NSCLC will receive blinded pembrolizumab in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by blinded pembrolizumab (on Day 1) Q3W until disease progression or treatment discontinuation.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Randomization to date of first documented disease progression or death (up to approximately 15 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemDetroitMichigan48202-2689-
Renown Regional Medical Center HospitalRenoNevada89502-1576-

Related coverage on Hipa.ai

Find similar trials in Detroit, MI

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Henry Ford Health System· Detroit, MIRenown Regional Medical Center Hospital· Reno, NV

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