Clinical trial NCT05796726: 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
Official title: Retrospective Chart Review and Historical Comparison of Capmatinib vs. Standard of Care for German Adult Patients With Locally Advanced or Metastatic NSCLC Harboring METex14 Mutations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring METex14 Mutations
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

Brief 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.


Eligibility criteria: Inclusion criteria

* NSCLC (any histology)

  * METex14 mutation
  * Epidermal Growth Factor Receptor (EGFR) wildtype
  * Anaplastic lymphoma kinase (ALK) rearrangement negative
* Stage IV or Stage IIIB without indication for local therapy
* First or second line of treatment
* Age ≥18 years Exclusion criteria
* Prior treatment with crizotinib, capmatinib, tepotinib or other MET inhibitors
* Carcinomatous meningitis
* Symptomatic brain metastases
* Eastern Cooperative Oncology Group Status (ECOG) \>1
* Uncontrolled, clinically significant heart diseases
* Malignant disease other than NSCLC within the past 3 years

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to an average of approximately 18 months
measure: Progression-free survival (PFS)
timeFrame: Up to an average of approximately 18 months
measure: Time to central nervous system (CNS) progression (CNSprog)
timeFrame: Up to an average of approximately 18 months
measure: Overall response rate (ORR)
timeFrame: Up to an average of approximately 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gießen
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: