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)

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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• Germany
  • Berlin, 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
  • Köln, Germany
    • Novartis Investigative Site
  • München, Germany
    • Novartis Investigative Site
  • Tübingen, Germany
    • Novartis Investigative Site
  • Würzburg, Germany
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Capmatinib Patients; Patients who received first- or second-line treatment with capmatinib in Study GEOMETRY mono-1
Standard of Care Patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Up to an average of approximately 18 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): March 22, 2022
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CINC280ADE01