Non Small Cell Lung CancerFRAMENCT01067794
Chemotherapy in Treating Patients With Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Eli Lilly and Company.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Any platinum-based doublet chemotherapy
- How many people
- 1,610 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (> 18 yrs.) initiating first-line treatment for advanced or metastatic (stage IIIB-IV) NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents treated in public hospitals, private hospitals or by office based physicians
Who may be able to join
- 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
Who cannot join
- Participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study
About this study
Official title: First-line Treatment of Non-Small Cell Lung Cancer Under Routine Conditions: Observational Study on Overall Survival
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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Any platinum-based doublet chemotherapy
- Keywords
- Metastatic, Advanced, Stage IIIB-IV, daily, hospital, practice, setting
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any platinum-based doublet chemotherapyDrug
Dosage, dosage form, frequency and duration according to daily hospital practice
| Study group | Role | What they receive |
|---|---|---|
| pemetrexed + platinum | Patients with pemetrexed + platinum doublet, with or without additional targeted agents Receives: Drug: Any platinum-based doublet chemotherapy | |
| gemcitabine + platinum | Patients with gemcitabine + platinum doublet, with or without additional targeted agents Receives: Drug: Any platinum-based doublet chemotherapy | |
| taxanes + platinum | Patients with taxanes + platinum doublet, with or without additional targeted agents Receives: Drug: Any platinum-based doublet chemotherapy | |
| vinorelbine + platinum | Patients with vinorelbine + platinum doublet, with or without additional targeted agents Receives: Drug: Any platinum-based doublet chemotherapy | |
| others + platinum | Patients with other platinum-based doublet, with or without additional targeted agents Receives: Drug: Any platinum-based doublet chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 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 outcomes (3)
One-year survival rate
Measured: 12 months
Progression-free survival
Measured: 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
Measured: Treatment start to progression or treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067794
- Sponsor's protocol ID
- 13095
- Other IDs
- H3E-EW-B012
- Acronym
- FRAME
- Status last verified
- Aug 2012
- First submitted
- 1 Feb 2010
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Schnabel PA, Smit E, Carpeno Jde C, Lesniewski-Kmak K, Aerts J, Kraaij K, Visseren-Grul C, Dyachkova Y, Taipale K, Girvan A, Moro-Sibilot D. Influence of histology and biomarkers on first-line treatment of advanced non-small cell lung cancer in routine care setting: baseline results of an observational study (FRAME). Lung Cancer. 2012 Dec;78(3):263-9. doi: 10.1016/j.lungcan.2012.09.001. Epub 2012 Oct 4.
PubMed 23040326
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Treatment of Non-Small Cell Lung Cancer Under Routine Conditions: Observational Study on Overall Survival
- ClinicalTrials.gov ID
- NCT01067794
- Acronym / sponsor ID
- FRAME / 13095
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Metastatic, Advanced, Stage IIIB-IV, daily, hospital, practice, setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,610 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| pemetrexed + platinum | – | Drug: Any platinum-based doublet chemotherapyPatients with pemetrexed + platinum doublet, with or without additional targeted agents |
| gemcitabine + platinum | – | Drug: Any platinum-based doublet chemotherapyPatients with gemcitabine + platinum doublet, with or without additional targeted agents |
| taxanes + platinum | – | Drug: Any platinum-based doublet chemotherapyPatients with taxanes + platinum doublet, with or without additional targeted agents |
| vinorelbine + platinum | – | Drug: Any platinum-based doublet chemotherapyPatients with vinorelbine + platinum doublet, with or without additional targeted agents |
| others + platinum | – | Drug: Any platinum-based doublet chemotherapyPatients with other platinum-based doublet, with or without additional targeted agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (> 18 yrs.) initiating first-line treatment for advanced or metastatic (stage IIIB-IV) NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents treated in public hospitals, private hospitals or by office based physicians
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any platinum-based doublet chemotherapyDosage, dosage form, frequency and duration according to daily hospital practice | Drug | gemcitabine + platinum, others + platinum, pemetrexed + platinum, taxanes + platinum, vinorelbine + platinum |
Primary outcome
Overall survival
Time frame: 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)
3 secondary outcomes
One-year survival rate
Time frame: 12 months
Progression-free survival
Time frame: 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
Time frame: Treatment start to progression or treatment end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- Derived from this study: PubMed 23040326Schnabel PA, Smit E, Carpeno Jde C, Lesniewski-Kmak K, Aerts J, Kraaij K, Visseren-Grul C, Dyachkova Y, Taipale K, Girvan A, Moro-Sibilot D. Influence of histology and biomarkers on first-line treatment of advanced non-small cell lung cancer in routine care setting: baseline results of an observational study (FRAME). Lung Cancer. 2012 Dec;78(3):263-9. doi: 10.1016/j.lungcan.2012.09.001. Epub 2012 Oct 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Eli Lilly and Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.