Non-Squamous Non-Small Cell Lung CancerELEMENTNCT01836133
An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 5 sites in Serbia.
Trial summary
This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- Erlotinib 150 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 5 sitesSerbia
- Study dates
- May 2013to Jan 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer, with ECOG performance status of 0-1
Who may be able to join
- Adult participants, >/= 18 years of age
- Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate hematologic, renal and liver function
- Participant initiating treatment with Tarceva according to the Summary of Product Characteristics
Who cannot join
- Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
- Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
- Previous systemic anti-cancer treatment with HER1/EGFR inhibitor
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Serbia5 sites
Clinical Center of Serbia; Institute For Pulmology
Belgrade, 11000
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, 11000
Military Medical Academy; Clinic for Pulmonology
Belgrade, 11000
Institute for pulmonary diseases of Vojvodina
Kamenitz, 21204
Clinical Center Nis; Clinic for pulmonary diseases Knez Selo
Knez-Selo, 18000
About this study
Official title: Efficacy and Safety of Erlotinib (Tarceva® ) Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) , Subtype Adenocarcinoma, Who Have Good Performance Status (PS 0-1) - ELEMENT
This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- Erlotinib 150 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib 150 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib 150 mg | Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. Receives: Drug: Erlotinib 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.
Measured: Approximately 3 years
Secondary outcomes (2)
Percentage of Participants With Overall Response
Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions.
Measured: Approximately 3 years
Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease.
Measured: Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836133
- Sponsor's protocol ID
- ML28282
- Acronym
- ELEMENT
- Status last verified
- Mar 2017
- First submitted
- 17 Apr 2013
- Last updated
- 4 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Erlotinib (Tarceva® ) Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) , Subtype Adenocarcinoma, Who Have Good Performance Status (PS 0-1) - ELEMENT
- ClinicalTrials.gov ID
- NCT01836133
- Acronym / sponsor ID
- ELEMENT / ML28282
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Posted 4 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib 150 mg | – | Drug: Erlotinib 150 mgParticipants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer, with ECOG performance status of 0-1
Key inclusion criteria (5 listed)
- Adult participants, >/= 18 years of age
- Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate hematologic, renal and liver function
- Participant initiating treatment with Tarceva according to the Summary of Product Characteristics
Key exclusion criteria (3 listed)
- Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
- Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
- Previous systemic anti-cancer treatment with HER1/EGFR inhibitor
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 |
|---|---|---|
| Erlotinib 150 mg | Drug | Erlotinib 150 mg |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Approximately 3 years
PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.
2 secondary outcomes
Percentage of Participants With Overall Response
Time frame: Approximately 3 years
Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)
Time frame: Baseline up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 5 sites in Serbia.
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 5 inclusion and 3 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 4 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-Free Survival (PFS) (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.