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Retrospective Chart Review and Historical Comparison of Capmatinib vs. Standard of Care for German Adult Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring METex14 Mutations

NCT05796726 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2023-04-03

No results posted yet for this study

Summary

The objective of the study was to compare the therapeutic benefit of capmatinib versus appropriate comparative therapy (ACT) defined by the German HTA agency G-BA for its benefit assessment of capmatinib but also versus the standard of care (SoC) practiced in German routine care. Due to its design as an adjusted, patient-level comparison, the RECAP study addresses the evidence gap due to the single-arm nature of pivotal evidence for capmatinib.

For this purpose, data on patients treated with ACT resp. SoC in German routine care has been collected via a retrospective chart review. This data was then used as an external control for a non-randomized, patient-level adjusted comparison with data from the GEOMETRY mono-1 study of capmatinib (NCT02414139).

Due to the non-interventional nature of this study, the definition of endpoints as primary or secondary was omitted formally.

Conditions

  • Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring METex14 Mutations

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2022-03-22
Completion
2022-03-22

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05796726 on ClinicalTrials.gov