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A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501252-28-00
Acronym
MK-7684A-002
Enrollment
150
Registered
2023-02-13
Start date
2021-04-15
Completion date
2024-10-10
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung cancer

Brief summary

Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment

Detailed description

Objective Response (OR) per RECIST 1.1 by BICR Assessment, Overall Survival (OS), Duration of Response (DOR) per RECIST 1.1 by BICR Assessment, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE

Interventions

DRUGPlacebo to MK-7684A - normal saline
DRUGDOCETAXEL

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment

Secondary

MeasureTime frame
Objective Response (OR) per RECIST 1.1 by BICR Assessment, Overall Survival (OS), Duration of Response (DOR) per RECIST 1.1 by BICR Assessment, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE

Countries

Austria, Belgium, Denmark, Finland, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026