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A non-interventional biomarker study in patients with NSCLC of adenocarcinoma tumour histology eligible for treatment with Vargatef according to the approved label

A non-interventional biomarker study in patients with NSCLC of adenocarcinoma tumour histology eligible for treatment with Vargatef according to the approved label - Biomarker study in patients with NSCLC

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46049
Enrollment
34
Registered
2016-01-05
Start date
2016-04-11
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer Non small-cell lung carcinoma

Interventions

None listed

Sponsors

Boehringer Ingelheim
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma - Vargatef is initiated and administered in accordance with the SPC - Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5 um thickness).

Exclusion criteria

Exclusion criteria: - Any contraindication to Vargatef or docetaxel as specified in their respective labels - Vargatef initiated from more than 7 days prior to inclusion in this NIS - Patients participating simultaneously in another NIS or a clinical trial

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS). OS is defined as the time from start of entering the study to time of death (irrespective of reason).

Secondary

MeasureTime frame
Time since start of first line therapy until start of Vargatef® therapy Time since start of first line therapy until start of Vargatef® therapy is divided into 2 subgroups as follows: • *Late progression group*: time from start of first line therapy until start of Vargatef® >=9 months (T>=9) • *Early progression group*: time from start of first line therapy until start of Vargatef®

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)