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

Novartis Pharmaceuticals260 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

260

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Cologne, Germany

Novartis Investigative Site

Düsseldorf, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Frankfurt, Germany

Novartis Investigative Site

Giessen, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Tübingen, Germany

Novartis Investigative Site

Würzburg, Germany

Outcomes

Primary Outcomes

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