Recruiting

Observational Study

Sponsor:

EMD Serono Research & Development Institute, Inc.

Code:

NCT05376891

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time.

The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14(METex14) participants treated with systemic therapy.

Conditions

Cancer

Study ID

NCT05376891

Start date

Oct 4, 2022

Status verified date

Aug, 2026

Completion date

Apr 28, 2028

Anticipated

Primary completion date

Apr 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants who signed ICF
  • Participants with advanced stage (stages IIIB-IV) NSCLC (all histologies) and Confirmed METex14 skipping alterations (by valid assay)
  • Participants who are starting or are already being treated with systemic therapy

Exclusion Criteria:

  • Participants who are enrolled in a clinical trial

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

Advanced Non-small Cell Lung Cancer with METex14 skipping alterations

Participants diagnosed with advanced NSCLC and who receive available therapies in routine clinical practice setting will be part of this registry. Data will be collected routinely from the point of enrollment of a participants into the registry until death, loss to follow-up (drop-out), subsequent enrollment into a clinical trial, or end of data collection period for the registry.

Primary outcome measure

  • Best Overall Response (BOR) [ Time Frame: Through study completion, up to approximately 4.9 years ]
  • Tumor Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 [ Time Frame: Up to approximately 4.9 years ]
  • Overall Survival (OS) [ Time Frame: Through study completion, up to approximately 4.9 years ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 4.9 years ]
  • Number of Participants with Adverse Reactions (ARs) [ Time Frame: Up to approximately 4.9 years ]

Central Contacts and Locations

Central contacts

US Medical Information

888-275-7376eMediUSA@emdserono.com

Communication Center

+49 6151 72 5200service@emdgroup.com

Locations

Holy Cross Health

Recruiting

Fort Lauderdale, Florida, United States, 33308-4603

Contacts

guchuan@hotmail.com

Principal Investigator:

David Drew

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43221

Contacts

david.carbone@osumc.edu

Principal Investigator:

David Carbone

Ottawa Hospital General Campus

Recruiting

Ottawa, Canada

Contacts

pwheatleyprice@toh.ca

Principal Investigator:

Paul Wheatley-Price

Centre Intégré de Cancérologie du CHU de Québec

Recruiting

Québec, Canada, G1J0J9

Contacts

nicolas.marcoux.1@ulaval.ca

Principal Investigator:

Nicolas Macroux

Princess Margaret Cancer Centre

Recruiting

Toronto, Canada

Contacts

geoffrey.liu@uhn.ca

Principal Investigator:

Geoffrey Liu

British Columbia Cancer Agency (6864)

Recruiting

Vancouver, Canada, V5Z 4E6

Contacts

cho@bccancer.bc.ca

Principal Investigator:

Cheryl Ho

More Information

Sponsor

EMD Serono Research & Development Institute, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Disease Registry
  • METex14 Skipping Alterations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc. on 2026-08-17.