# TeliMET NSCLC-01

Source: https://onco.cc/trials/telimet-nsclc-01/  
OnCo record `telimet-nsclc-01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The confirmatory trial for the first c-MET ADC, which was approved early on response rate alone.

## Summary

TeliMET NSCLC-01, trial NCT04928846 sponsored by AbbVie, is the randomised phase 3 confirmatory trial for telisotuzumab vedotin, the first c-MET antibody-drug conjugate, which received accelerated approval in May 2025 on response rate alone. It compares telisotuzumab vedotin with docetaxel in previously treated c-Met-overexpressing, EGFR-wild-type non-squamous non-small-cell lung cancer and plans to enrol 768 patients, with enrolment ongoing and no results available. The accelerated approval rested on the single-arm LUMINOSITY study, in which about a third of patients with high c-Met expression responded, and OnCo links the trial to MET as a target. Whether a response-rate approval converts into a survival advantage over chemotherapy is exactly what this trial exists to answer. Telisotuzumab vedotin has its own page.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-06
- Registry id: NCT04928846
- Phase: 3
- Setting: Previously treated c-Met-overexpressing, EGFR-wild-type non-squamous NSCLC: telisotuzumab vedotin vs docetaxel
- Sponsor: AbbVie
- Enrolled: 768
- Replication: Ongoing confirmatory trial for the LUMINOSITY-based accelerated approval.

## Sources

- ClinicalTrials.gov NCT04928846: https://clinicaltrials.gov/study/NCT04928846

## Connected records

- cancers: [MET exon 14 and MET-amplified non-small-cell lung cancer](https://onco.cc/cancers/met-altered-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [MET](https://onco.cc/targets/met/)
- drugs: [Telisotuzumab vedotin](https://onco.cc/drugs/telisotuzumab-vedotin/)
- companies: [AbbVie (incl. ImmunoGen, Capstan)](https://onco.cc/companies/abbvie/)
- roadmaps: [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/)

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