# KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

Source: https://onco.cc/trials/nct04165070/  
OnCo record `nct04165070` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Pembrolizumab, Carboplatin, Pemetrexed and Ifinatamab deruxtecan in non-small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.

## Summary

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) is a phase 1/2 interventional study registered as NCT04165070 by Merck Sharp & Dohme LLC, with 450 participants planned, started 2019-12-19 and due to reach its primary completion in 2032-02-13. Interventions recorded: Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed, Vibostolimab and Boserolimab.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04165070
- Phase: 1/2
- Setting: KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
- Sponsor: Merck Sharp & Dohme LLC
- Enrolled: 450

## Sources

- ClinicalTrials.gov NCT04165070: https://clinicaltrials.gov/study/NCT04165070

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- drugs: [Boserolimab](https://onco.cc/drugs/boserolimab/), [Carboplatin](https://onco.cc/drugs/carboplatin/), [Ifinatamab deruxtecan](https://onco.cc/drugs/ifinatamab-deruxtecan/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Pemetrexed](https://onco.cc/drugs/pemetrexed/), [Vibostolimab](https://onco.cc/drugs/vibostolimab/)
- companies: [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/), [Merck & Co. (MSD)](https://onco.cc/companies/merck/)

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