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Clinical Trial 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05796726
Study type Observational
Source Novartis
Contact
Status Completed
Phase
Start date December 10, 2021
Completion date March 22, 2022