Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden

Sponsor
AIO-Studien-gGmbH
Study ID
NCT07715396
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Tislelizumab — DRUG
    Tislelizumab monotherapy 200 mg i.v. q3w
  • Tislelizumab Combined With Chemotherapy — DRUG
    Non-squamous NSCLC: tislelizumab 200 mg i.v. + platinum-based chemotherapy (cisplatin 75 mg/m2 i.v. or carboplatin AUC 5-6 i.v.) + pemetrexed 500 mg/m2 i.v.; squamous NSCLC: tislelizumab 200 mg i.v. + carboplatin AUC 5-6 i.v. + (nab)paclitaxel (nab-paclitaxel 100 mg/m2 i.v., paclitaxel 175 or 200 mg/m2 i.v.
  • Pembrolizumab — DRUG
    Pembrolizumab monotherapy 200 mg i.v. q3w

Study Details

AIO-TRK/YMO-0425 (High Five) is a phase III, open-label randomized-controlled, multicenter study to evaluate the progression-free survival by the addition of platinum-based chemotherapy to immunotherapy (IO) compared to IO monotherapy in patients with PD-L1high mNSCLC featuring a high tumor burden.

Key Dates

First listed
Jul 20, 2026
Start date
Oct 30, 2026
Status verified
Jul 2026
Primary completion
Oct 30, 2031
Completion
Oct 30, 2031

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Immune-monotherapy
    Tislelizumab monotherapy 200 mg i.v. q3w or pembrolizumab monotherapy 200 mg i.v. q3w or
  • Experimental: Tislelizumab + platinum-based doublet chemotherapy
    Non-squamous NSCLC: tislelizumab 200 mg i.v. + platinum-based chemotherapy (cisplatin 75 mg/m2 i.v. or carboplatin AUC 5-6 i.v.) + pemetrexed 500 mg/m2 i.v.; squamous NSCLC: tislelizumab 200 mg i.v. + carboplatin AUC 5-6 i.v. + (nab)paclitaxel (nab-paclitaxel 100 mg/m2 i.v., paclitaxel 175 or 200 mg/m2 i.v.

Primary Outcome Measure

Progression-free survival [ Time Frame: max. 50 months ]

Central Contacts

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