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

Completed

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

• Registration Number: NCT05796726
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-10
• Primary Completion: 2022-03-22
• Study Completion: 2022-03-22
• Status Verified: 2023-03
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	Up to an average of approximately 18 months	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.
Overall survival (OS)	Up to an average of approximately 18 months	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.
Progression-free survival (PFS)	Up to an average of approximately 18 months	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 to central nervous system (CNS) progression (CNSprog)	Up to an average of approximately 18 months	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Würzburg, Germany