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MarsLight-11NCT07217301

A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer

StatusRecruiting
PhasePhase 3
SponsorTakeda
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from Takeda

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Record History

All 10 versions: 9 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 600 → 1200 participants Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria shortened, about 46 words
    • Trial sites expanded: 46 → 50 locations
    • Secondary endpoints: 20 to 21
  2. Study sites: 45 to 46v9
  3. Study sites: 44 to 45v8
  4. Sponsor changed: Fortvita Biologics (USA)Inc. to Takedav6 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 592 words
    • Interventions: Control Arm (Drug), IBI363 (Drug) to Control Arm (Drug), TAK-928 (Drug)
    • Secondary endpoints: 11 to 20
    • Study sites revised (44)
    • Collaborators: 2 to 1
    • Study title shortened, about 2 words
  5. Study sites: 42 to 44v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 3 to 42v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 3
    • Start date changed from estimate of Oct 30, 2025 to Nov 26, 2025
    • Collaborators: 1 to 2
    v3
  3. Start date: Oct 11, 2025 to Oct 30, 2025
    • Secondary endpoints: details revised at 2 of 11 entries
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Squamous NSCLC Part: Confirmed Objective Response Rate (cORR) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1
Timeframe: Up to 26 months
Squamous and Nonsquamous NSCLC Part: Overall Survival (OS)
Timeframe: Up to 26 months
SRI Part: Percentage of Participants with Dose-limiting Toxicities (DLTs)
Timeframe: Up to 28 days after first dose (Day 1)
SRI Part: Percentage of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Immune-Related Adverse Events (irAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation and Deaths
Timeframe: From screening up to 26 months

Secondary (21)

Squamous and Nonsquamous NSCLC; SRI Part: Confirmed Objective Response Rate (cORR) as Assessed by Investigator per RECIST V1.1
Squamous and Nonsquamous NSCLC Part: Progression-free survival (PFS), as Assessed by BICR and Investigator per RECIST V1.1
Nonsquamous NSCLC Part: cORR as Assessed by Investigator per RECIST V1.1
Squamous and Nonsquamous NSCLC Part: Disease Control Rate (DCR) as Assessed by BICR and Investigator per RECIST V1.1
Squamous and Nonsquamous NSCLC Part: Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST V1.1
Show 16 moreShow less
Squamous and Nonsquamous NSCLC Part: Time to Response (TTR) as Assessed by BICR and Investigator per RECIST V1.1
SRI Part: DCR as Assessed by Investigator per RECIST V1.1
SRI Part: DOR as Assessed by Investigator per RECIST V1.1
SRI Part: TTR as Assessed by Investigator per RECIST V1.1
Squamous and Nonsquamous NSCLC Part: Percentage of Participants With TEAEs, irAEs, SAEs, AESIs and TEAEs Leading to Discontinuation and Deaths
Squamous and Nonsquamous NSCLC; SRI Part: Pharmacokinetic parameters including Terminal Half-Life (t½) of TAK-928
Squamous and Nonsquamous NSCLC; SRI Part: Pharmacokinetic parameters including Clearance (CL) of TAK-928
Squamous and Nonsquamous NSCLC; SRI Part: Pharmacokinetic parameters including Volume of Distribution (Vd) of TAK-928
Squamous and Nonsquamous NSCLC; SRI Part: Number of Participants Who Develop Anti-Drug Antibodies (ADA) and/or Neutralizing Antibody (Nab) to TAK-928
Squamous and Nonsquamous NSCLC Part: Time to Deterioration (TTD) in in GHS/QoL and Dyspnea as Measured by the EORTC QLQ-C30
Squamous and Nonsquamous NSCLC Part: Change from Baseline in GHS/ Quality of Life (QoL) Score (Item 29 & 30) and Dyspnea (Item 8) Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Squamous and Nonsquamous NSCLC Part: Change From Baseline in Functioning Scale Scores as Measured by the EORTC QLQ-C30
Squamous and Nonsquamous NSCLC Part: Change From Baseline in Symptom Scale Scores as Measured by the EORTC QLQ-C30
Squamous and Nonsquamous NSCLC Part: Change From Baseline in Single Item Symptom Questions as Measured by the EORTC QLQ-C30
Squamous and Nonsquamous NSCLC Part: Change From Baseline in Visual Analogue Scale (VAS) Scores as Measured by EuroQol Five-dimensional Five-level Questionnaire (EQ-5D-5L)
Squamous and Nonsquamous NSCLC Part: Change From Baseline in Symptoms of Lung Cancer as Assessed With the EORTC QLQ- Lung Cancer (LC) 13 (QLQ-LC13)

Arms and interventions

TAK-928Experimental

TAK-928 is a first-in-class bispecific monoclonal antibody (mAb) comprised of an interleukin-2 (IL-2) mutein fused with a recombinant anti-programmed cell death protein 1 (anti-PD-1) mAb. TAK-928 was precisely designed and constructed to afford targeted binding of tumor-specific CD8+ T cells (TSTs) that co-express PD-1 and CD25 (IL2Ra) receptors. The mechanism of action of TAK-928 is blocking the PD-(L)1 and activating the IL-2 pathways simultaneously to reverse T cell exhaustion and promote activation of T cells and natural killer (NK) cells, and consequently eliminate tumor cells.

ControlActive comparator

Docetaxel or comparable generic brand

Drugs: TAK-928, Control Arm

Sites

50 sites in 3 countries

China 37, United States 12, Japan 1