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NCT06159790 · ClinicalTrials.gov registry record · Phase 3

A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

A Phase 3 study, sponsored by Sandoz.

Completed
Registry status
Phase 3
Development phase
218
Enrollment target

NCT06159790: Completed Phase 3 study, sponsored by Sandoz.

NCT06159790 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 218 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06159790, a Phase 3 study, has completed, sponsored by Sandoz.

COMPLETED
Registry status
Phase 3
Development phase
218 participants
Enrollment target

Study Summary

The purpose of this study is to investigate the efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status), without sensitizing EGFR or ALK mutations.

Primary Outcome

Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) up to 9 months according to RECIST 1.1 as assessed by Blinded Central Imaging

Interventions

  • DRUG GME751
  • DRUG Keytruda-EU

Trial Details

FieldValue
Enrollment Target 218 participants
Start Date 2024-04-29
Est. Completion 2026-03-16
Phase Phase 3
Sandoz

29 total trials

What the finished NCT06159790 record still lists

NCT06159790 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 2 interventions - of which GME751 is the first listed.

NCT06159790 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06159790 about?

NCT06159790 is a clinical study titled "A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)". The purpose of this study is to investigate the efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status), without sensitizing EGFR or ALK mutations.

What is the current status of trial NCT06159790?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2024-04-29. Estimated completion is 2026-03-16.

What interventions are being tested in trial NCT06159790?

The interventions under investigation include: GME751 (DRUG), Keytruda-EU (DRUG).

Who is sponsoring clinical trial NCT06159790?

This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06159790's enrollment target sits among peer trials

218 1331st of 2000 higher than 669 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06159790, the US trial registry maintained by the National Library of Medicine. NCT06159790 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.