Chemotherapy in Treating Patients With Lung Cancer

First-line Treatment of Non-Small Cell Lung Cancer Under Routine Conditions: Observational Study on Overall Survival

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01067794

Acronym

FRAME

Enrollment

1610

Registered

2010-02-12

Start date

2009-04-30

Completion date

2012-07-31

Last updated

2012-08-24

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

Conditions

Non Small Cell Lung Cancer

Keywords

Metastatic, Advanced, Stage IIIB-IV, daily, hospital, practice, setting

Brief summary

This observational study was planned, with the primary objective to observe patient survival following first-line treatment of patients of Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) with different platinum-based doublets under routine disease management conditions. Further secondary objectives of this study are to provide insights to what extent histologic subtyping and the use of additional prognostic or predictive biomarkers are currently considered for differential therapeutic decisions under routine conditions. All of these data are critical to evaluate the factors for differential therapeutic decisions and their effect on patient outcomes in a real life setting, and they can only be obtained through observational research.

Interventions

DRUGAny platinum-based doublet chemotherapy

Dosage, dosage form, frequency and duration according to daily hospital practice

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) stage IIIB-IV * Initiation of first-line treatment for advanced NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents * 18 years of age or older

Exclusion criteria

* Participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study

Design outcomes

Primary

Measure	Time frame
Overall survival	Treatment start to death from any cause (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)

Secondary

Measure	Time frame
One-year survival rate	12 months
Progression-free survival	Treatment start to progression or death (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)
Best tumor response	Treatment start to progression or treatment end

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026