RECAP: 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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT05796726

Collaborator

(none)

260

Enrollment

Locations

3.4

Actual Duration (Months)

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring METex14 Mutations

Study Design

Study Type:

Observational

Actual Enrollment :

260 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 10, 2021

Actual Primary Completion Date :

Mar 22, 2022

Actual Study Completion Date :

Mar 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Berlin	Germany
2	Novartis Investigative Site	Düsseldorf	Germany
3	Novartis Investigative Site	Erlangen	Germany
4	Novartis Investigative Site	Essen	Germany
5	Novartis Investigative Site	Frankfurt	Germany
6	Novartis Investigative Site	Gießen	Germany
7	Novartis Investigative Site	Köln	Germany
8	Novartis Investigative Site	München	Germany
9	Novartis Investigative Site	Tübingen	Germany
10	Novartis Investigative Site	Würzburg	Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT05796726

Other Study ID Numbers:

CINC280ADE01

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 3, 2023