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

NCT07715396 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Non-small Cell Lung Cancer Metastatic

Interventions

DRUG

Tislelizumab

Tislelizumab monotherapy 200 mg i.v. q3w

DRUG

Tislelizumab Combined With 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.

DRUG

Pembrolizumab

Pembrolizumab monotherapy 200 mg i.v. q3w

Sponsors & Collaborators

  • BeOne Medicines

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2031-10-30
Completion
2031-10-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715396 on ClinicalTrials.gov