Non-small-cell Lung Cancer With Somatic EGFR MutationsPhase 2Trans-MARBLENCT02595840
Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
A Phase 2 study testing Afatinib and Pemetrexed in people with Non-small-cell Lung Cancer With Somatic EGFR Mutations, run by Universität Duisburg-Essen.
Trial summary
To compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic EGFR mutated non-small-cell lung cancer progressing after first-line treatment with afatinib as first tyrosine kinase inhibitor with respect to progression-free… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer With Somatic EGFR Mutations
- What is being tested?
- Afatinib and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2015to 20 Nov 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
- Participation in the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
- Written informed consent
Who cannot join
- 1. Patients who do not meet the inclusion criterial of the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
About this study
To compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic EGFR mutated non-small-cell lung cancer progressing after first-line treatment with afatinib as first tyrosine kinase inhibitor with respect to progression-free survival
Read the detailed description
Patients who have progressed after first-line treatment with afatinib as first tyrosine kinase inhibitor (TKI) will be screened while they are receiving second-line (induction) treatment consisting of cisplatin / carboplatin plus pemetrexed given in 21-day cycles. Patients who do not progress (i.e. complete or partial response, or stable disease - CR, PR or SD) after completion of at least three and not more than four chemotherapy cycles will be randomized (1:1 ratio) to receive maintenance therapy with either afatinib (40 mg/d or last tolerated dose during first-line treatment with afatinib as first TKI) or pemetrexed (500 mg/m2 or 375 mg/m2 if dose reduction was required every 21 days) until disease progression or treatment discontinuation because of patient decision or toxicity.
- Being tested
- Afatinib, Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
PemetrexedDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Afatinib | Experimental | Afatinib 40 mg/d (30, or 20 mg/d in case of dose reduction during 1st line treatment) Receives: Drug: Afatinib |
| Arm B: Pemetrexed | Experimental | Pemetrexed 500 mg/m2 (375 mg/m² in case of dose reduction during induction therapy) i.v. on d1 of each 21-day cycle Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival in relation to exploratory biomarkers
Measured: until progression
Secondary outcomes (2)
Overall Survival in relation to exploratory biomarkers
Overall survival
Measured: continuous assessment
Objective response rate
Objective response rate, clinical benefit rate (RECIST 1.1)
Measured: Assessed every 6 weeks for 24 weeks, then every 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start25 Nov 2015
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Why it stopped: Futility
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 Cancer With Somatic EGFR MutationsStudies 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
- Model description
- A randomized, open-label, phase II study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Schuler, Prof. Dr. med., Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595840
- Sponsor's protocol ID
- EudraCT-Nr. 2014-001983-36
- Acronym
- Trans-MARBLE
- Status last verified
- Apr 2019
- First submitted
- 23 Oct 2015
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
- ClinicalTrials.gov ID
- NCT02595840
- Acronym / sponsor ID
- Trans-MARBLE / EudraCT-Nr. 2014-001983-36
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 4 Nov 2015 (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.
To compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic EGFR mutated non-small-cell lung cancer progressing after first-line treatment with afatinib as first tyrosine kinase inhibitor with respect to progression-free survival
Detailed description
Patients who have progressed after first-line treatment with afatinib as first tyrosine kinase inhibitor (TKI) will be screened while they are receiving second-line (induction) treatment consisting of cisplatin / carboplatin plus pemetrexed given in 21-day cycles. Patients who do not progress (i.e. complete or partial response, or stable disease - CR, PR or SD) after completion of at least three and not more than four chemotherapy cycles will be randomized (1:1 ratio) to receive maintenance therapy with either afatinib (40 mg/d or last tolerated dose during first-line treatment with afatinib as first TKI) or pemetrexed (500 mg/m2 or 375 mg/m2 if dose reduction was required every 21 days) until disease progression or treatment discontinuation because of patient decision or toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-label, phase II study
| Arm | Type | Receives |
|---|---|---|
| Arm A: Afatinib | Experimental | Drug: AfatinibAfatinib 40 mg/d (30, or 20 mg/d in case of dose reduction during 1st line treatment) |
| Arm B: Pemetrexed | Experimental | Drug: PemetrexedPemetrexed 500 mg/m2 (375 mg/m² in case of dose reduction during induction therapy) i.v. on d1 of each 21-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participation in the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
- Written informed consent
Key exclusion criteria (1 listed)
- 1. Patients who do not meet the inclusion criterial of the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
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 |
|---|---|---|
| Afatinib | Drug | Arm A: Afatinib |
| Pemetrexed | Drug | Arm B: Pemetrexed |
Primary outcome
Progression-free Survival in relation to exploratory biomarkers
Time frame: until progression
2 secondary outcomes
Overall Survival in relation to exploratory biomarkers
Time frame: continuous assessment
Objective response rate
Time frame: Assessed every 6 weeks for 24 weeks, then every 9 weeks
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afatinib and Pemetrexed in people with Non-small-cell Lung Cancer With Somatic EGFR Mutations, run by Universität Duisburg-Essen.
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 2 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: stopped early, as of the sponsor's last update on 19 Apr 2019. 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.
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 was stopped early (reason given: Futility). Results are not available in the source record.
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 in relation to exploratory biomarkers (time frame: until progression). 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 19 Apr 2019.