Clinical trial · Observational
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring METex14 Mutations | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Capmatinib Patients
- description
- Patients who received first- or second-line treatment with capmatinib in Study GEOMETRY mono-1
- label
- 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
Primary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- Up to an average of approximately 18 months
- description
- 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.
- measure
- Progression-free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available