Non-small Cell Lung CancerPhase 2NCT02064491
Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC
A Phase 2 study testing Erlotinib and Chemotherapy in people with Non-small Cell Lung Cancer, run by Finnish Lung Cancer Group at 7 sites in Finland.
Trial summary
The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI. 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 and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesFinland
- Study dates
- Feb 2014to 31 May 2017
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed stage IIIB/IV NSCLC.
- Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
- Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
- Performance status: WHO 0-2
- Measurable disease according to RECIST 1.1
- Patients must be able to comply with study treatments
Show all 9Show fewer
- Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
- Neutrophils ≥ 1'000/μl, Platelets ≥ 100'000/μl, Alanine amino transferase ≤ 2.5 × Upper limit of normal (ULN) (< 5 × ULN if liver metastases), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum bilirubin ≤ 1.5 × ULN, Serum Creatinine ≤ 1.5 × ULN.
- Patient must be able to comply with the protocol
Who cannot join
- RECIST 1.1 defined disease progression for more than 28 days while on previous EGFR TKI treatment.
- Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
- Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
- Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
- Patient with symptomatic central nervous system metastases
- Patient has known active hepatitis B or C, or HIV infection
- Pregnant or breastfeeding.
- Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Finland7 sites
Helsinki University Hospital
Espoo
Helsinki University Hospital
Helsinki
Oulu University Hospital
Oulu
Pori Central Hospital
Pori
Tampere University Hospital
Tampere
Turku University Hopital
Turku
Vaasa Central Hospital
Vaasa
About this study
Official title: Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC
The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.
Read the detailed description
A Phase II randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have EGFR mutant or EGFR TKI responsive NSCLC and have progressed on EGFR TKI.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Erlotinib, Chemotherapy
- Keywords
- Non-small cell lung cancer, EGFR mutant, Erlotinib, Treatment Beyond Progression
- 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
ChemotherapyDrug
Also called Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib and Chemotherapy | Experimental | Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance Receives: Drug: Erlotinib; Drug: Chemotherapy |
| Chemotherapy | Active comparator | Chemotherapy for four to six cycles Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival of the whole study population and in the strata 1-2
Measured: An expected average of 36 weeks after last subject enrolled into our study
Secondary outcomes (4)
Overall Survival
Measured: An expected average of 52 weeks after last subject enrolled into our study
Overall Response Rate
Measured: An expected average of 36 weeks after last subject enrolled into our study
Rate of non-progression at 9 and 18 weeks
Measured: 18 weeks after date of randomization of a last patient
Safety and toxicity
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: An expected average of 52 weeks after last subject enrolled into our study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion31 Dec 2016
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Lung Cancer Group
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064491
- Sponsor's protocol ID
- ETAP
- Other IDs
- 2013-002049-13
- Status last verified
- Jun 2017
- First submitted
- 13 Feb 2014
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC
- ClinicalTrials.gov ID
- NCT02064491
- Acronym / sponsor ID
- ETAP
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, EGFR mutant, Erlotinib, Treatment Beyond Progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Finnish Lung Cancer GroupUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Feb 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 17 Feb 2014 (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.
The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.
Detailed description
A Phase II randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have EGFR mutant or EGFR TKI responsive NSCLC and have progressed on EGFR TKI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib and Chemotherapy | Experimental | Drug: Erlotinib, Drug: ChemotherapyIntercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance |
| Chemotherapy | Active comparator | Drug: ChemotherapyChemotherapy for four to six cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed stage IIIB/IV NSCLC.
- Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
- Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
- Performance status: WHO 0-2
- Measurable disease according to RECIST 1.1
Key exclusion criteria (8 listed)
- RECIST 1.1 defined disease progression for more than 28 days while on previous EGFR TKI treatment.
- Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
- Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
- Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
- Patient with symptomatic central nervous system metastases
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: Tarceva | Drug | Erlotinib and Chemotherapy |
| ChemotherapyAlso: Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed | Drug | Chemotherapy, Erlotinib and Chemotherapy |
Primary outcome
Progression-free survival of the whole study population and in the strata 1-2
Time frame: An expected average of 36 weeks after last subject enrolled into our study
4 secondary outcomes
Overall Survival
Time frame: An expected average of 52 weeks after last subject enrolled into our study
Overall Response Rate
Time frame: An expected average of 36 weeks after last subject enrolled into our study
Rate of non-progression at 9 and 18 weeks
Time frame: 18 weeks after date of randomization of a last patient
Safety and toxicity
Time frame: An expected average of 52 weeks after last subject enrolled into our study
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 22 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib and Chemotherapy in people with Non-small Cell Lung Cancer, run by Finnish Lung Cancer Group at 7 sites in Finland.
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 9 inclusion and 8 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 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Finland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Progression-free survival of the whole study population and in the strata 1-2 (time frame: An expected average of 36 weeks after last subject enrolled into our study). 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 22 Jun 2017.