An observational study in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring METex14 Mutations, sponsored by Novartis Pharmaceuticals. Completed at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 260 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
This was a retrospective, noninterventional cohort study
Inclusion criteria
NSCLC (any histology)
Patients who received first- or second-line treatment with capmatinib in Study GEOMETRY mono-1
Patients who received appropriate comparative therapy (ACT) defined by the German HTA agency G-BA or standard of care (SoC) practiced in German routine care
Overall survival (OS)
OS was defined as time from start of treatment to death due to any cause. Per the protocol and due to the non-interventional nature of this study, outcome measures were not formally ranked as primary or secondary.
Time frame: Up to an average of approximately 18 months
Progression-free survival (PFS)
PFS was defined as time from start of treatment to first documented disease progression or death due to any cause. Per the protocol and due to the non-interventional nature of this study, outcome measures were not formally ranked as primary or secondary.
Time frame: Up to an average of approximately 18 months
Time to central nervous system (CNS) progression (CNSprog)
For patients without brain metastases at start of treatment, CNSprog was defined as time from start of treatment to first radiologically documented brain metastases. Per the protocol and due to the non-interventional nature of this study, outcome measures were not formally ranked as primary or secondary.
Time frame: Up to an average of approximately 18 months
Overall response rate (ORR)
For external control patients, ORR was defined as proportion of patients with a radiologically documented decrease in sum of tumor lesions (primary tumor and metastases). Decrease in sum of tumor lesions included complete cessation of any radiologically detectable tumor lesions. For GEOMETRY mono-1 patients, ORR was defined as proportion of patients with a best overall response as complete response (CR) or partial response (PR). CR and PR were assessed per RECIST 1.1 by BIRC. Per the protocol and due to the non-interventional nature of this study, outcome measures were not formally ranked as primary or secondary.
Time frame: Up to an average of approximately 18 months
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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