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 (RECAP)

Novartis

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05796726

CINC280ADE01

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

260 participants in 2 patient groups

Capmatinib Patients

Description:

Patients who received first- or second-line treatment with capmatinib in Study GEOMETRY mono-1

Standard of Care Patients

Description:

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