Non-Small Cell Lung CancerPhase 3ESSENCENCT01667562
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 3 study testing Erlotinib in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 4 sites in Serbia.
Trial summary
This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). 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?
- Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 4 sitesSerbia
- Study dates
- 20 Jan 2012to 7 Sep 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
- Measurable disease according to RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematological, liver and renal function
- Participants with asymptomatic and stable cerebral metastases receiving medical treatment
Who cannot join
- Previous chemotherapy or treatment against EGFR for metastatic disease
- Treatment with an investigational agent less than 3 weeks before enrollment
- History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
- Participants with symptomatic cerebral metastases
- Any significant ophthalmologic abnormality
- Unstable systemic disease
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- Coumarins use
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
- Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
- Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
Trial locations and contacts
4 sites in 1 country.
Serbia4 sites
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade, 11000
Clinical Center Bezanijska Kosa; Oncology
Belgrade, 11080
Institute for pulmonary diseases of Vojvodina
Kamenitz, 21204
Clinical Center Nis; Clinic for pulmonary diseases Knez Selo
Niš
About this study
Official title: Phase IIIb, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Daily oral doses administered until disease progression or unacceptable toxicity or death.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity. Receives: Drug: Erlotinib |
| Diagnostic Phase | No intervention | Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.
Measured: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Secondary outcomes (5)
Proportion of Participants With Objective Response as Assessed by RECIST v 1.1
Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Proportion of Participants With Disease Control as Assessed by RECIST v 1.1
Disease control was defined as objective response or stable disease (SD) for at least 6 weeks. OR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of CR and PR four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations
Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21.
Measured: Screening up to approximately 7 days
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: Baseline up to approximately 4 years and 9 months
Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)
The domains in the Quality of life score using the Functional Assessment of Cancer Therapy Lung (FACT-L) include physical, social/family, emotional, and functional well-being, and a lung cancer subscale include symptoms, cognitive function and regret of smoking. Minimum and maximum value of the scale is 0 and 4, respectively. Higher score indicate better health state.
Measured: Baseline and end of study (approximately 4 years and 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study start20 Jan 2012
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
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-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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 375 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
- NCT01667562
- Sponsor's protocol ID
- ML27860
- Acronym
- ESSENCE
- Status last verified
- Dec 2019
- First submitted
- 15 Aug 2012
- Last updated
- 20 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIb, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
- ClinicalTrials.gov ID
- NCT01667562
- Acronym / sponsor ID
- ESSENCE / ML27860
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2012 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Posted 20 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: ErlotinibErlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity. |
| Diagnostic Phase | No intervention | –Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
- Measurable disease according to RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematological, liver and renal function
Key exclusion criteria (10 listed)
- Previous chemotherapy or treatment against EGFR for metastatic disease
- Treatment with an investigational agent less than 3 weeks before enrollment
- History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
- Participants with symptomatic cerebral metastases
- Any significant ophthalmologic abnormality
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 |
|---|---|---|
| ErlotinibAlso: TarcevaDaily oral doses administered until disease progression or unacceptable toxicity or death. | Drug | Erlotinib |
Primary outcome
Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.
5 secondary outcomes
Proportion of Participants With Objective Response as Assessed by RECIST v 1.1
Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Proportion of Participants With Disease Control as Assessed by RECIST v 1.1
Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations
Time frame: Screening up to approximately 7 days
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 4 years and 9 months
Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)
Time frame: Baseline and end of study (approximately 4 years and 9 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erlotinib in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 4 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 6 inclusion and 10 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2019). 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 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) (time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)). 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 20 Dec 2019.