Lung CancerPhase 3HER3-LungNCT02134015
Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
A Phase 3 study testing Patritumab and Erlotinib in people with Lung Cancer and Non-small Cell Lung Cancer, run by Daiichi Sankyo at 98 sites in 10 countries.
Trial summary
1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Patritumab and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 98 sitesin 10 countries
- Study dates
- Mar 2014to 11 Nov 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be greater or equal to 20 years of age
- Must have cytologically or histologically confirmed NSCLC with either:
- Metastatic disease (Stage IV) OR
- Stage IIIB disease not amenable to surgery or curative intent.
- Note: It is permissible to use either AJCC Version 6.0 or the AJCC Version 7.0 staging system. For sites that use AJCC Version 7.0, T4M0 patients with other ipsilateral nodules and N0-N2 are still eligible.
- If tumor histology is adenocarcinoma, must have wild-type EGFR genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (L858R) substitution.
Show all 16Show fewer
- Must have received one or two prior lines of systemic chemotherapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
- Must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
- Must have available recent (before treatment start) or archival tumor specimen.
- Must have measurable disease for Part A, measurable disease or non-measurable disease for Part B
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Must have adequate hematological function
- Must have adequate renal function
- Must have adequate hepatic function
- Agreement to use effective contraception while on treatment and for at least 6 months after end of treatment
- Must have provided informed consent for study participation.
Who cannot join
- Lung adenocarcinoma with an Anaplastic Lymphoma Kinase (ALK) gene rearrangement
- Left ventricular ejection fraction (LVEF) less than 45%
- Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
- History of corneal disease
- History of interstitial lung disease (ILD)
Show all 16Show fewer
- Clinically active brain metastases
- Uncontrolled hypertension
- Clinically significant ECG changes
- Clinically significant (in the opinion of the Investigator) ascites or pleural effusion requiring chronic medical intervention
- Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
- Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
- Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
- Participation in clinical drug trials within 4 weeks
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
- History of hypersensitivity to any of the study drugs or to any excipients.
Trial locations and contacts
98 sites in 10 countries.
98 sites in 10 countries
United States26 sites
Study site
Arlington, Virginia
Study site
Bend, Oregon
Study site
Chattanooga, Tennessee
Study site
Chicago, Illinois
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Duarte, California
Study site
Glendale, Arizona
Study site
Goshen, Indiana, 46526
Study site
Grand Rapids, Michigan
Study site
Knoxville, Tennessee
Study site
La Verne, California
Study site
Las Vegas, Nevada
Study site
Los Angeles, California, 43210
Study site
Louisville, Kentucky
Study site
Maywood, Illinois
Study site
Nashville, Tennessee
Study site
Port Saint Lucie, Florida
Study site
Portland, Oregon
Study site
Redmond, Oregon, 97756
Study site
Saint Cloud, Minnesota
Study site
Salt Lake City, Utah
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Tampa, Florida
Germany15 sites
Study site
Cologne, North Rhine-Westphalia
Study site
Esslingen am Neckar, Baden-Wurttemberg
Study site
Frankfurt am Main, Hesse
Study site
Gauting, Bavaria, 82131
Study site
Gerlingen, Baden-Wurttemberg
Study site
Giessen
Study site
Großhansdorf, Schleswig-Holstein
Study site
Halle, Saxony-Anhalt
Study site
Heidelberg, Baden-Wurttemberg
Study site
Immenhausen, Hesse
Study site
Mainz, Rhineland-Palatinate
Study site
Munich, Bavaria
Study site
Rheine, North Rhine-Westphalia
Study site
Ulm, Baden-Wurttemberg
Study site
Villingen-Schwenningen, Baden-Wurttemberg
Italy15 sites
Study site
Benevento
Study site
Bologna
Study site
Cremona
Study site
Faenza
Study site
Genova
Study site
Lecco, Lombardy
Study site
Meldola, Forli
Study site
Milan
Study site
Naples
Study site
Perugia
Study site
Ravenna
Study site
Rimini
Study site
Roma
Study site
Rozzano
Study site
Sora, Frosinone
Spain11 sites
Study site
A Coruña, A Coruña
Study site
Alicante
Study site
Barcelona
Study site
Burgos
Study site
Madrid
Study site
Manresa
Study site
Palma de Mallorca
Study site
Seville, Andalusia
Study site
Valencia, Valenciana, Comunidad
Study site
Valencia
Study site
Zaragoza
Belgium7 sites
Study site
Brasschaat, Antwerpen
Study site
Brussels, Brussels Capital
Study site
Charleroi, Hainaut
Study site
Charleroi
Study site
Ghent, 9000
Study site
Liège
Study site
Yvoir, 5530
Poland7 sites
Study site
Gdansk, Pomeranian Voivodeship
Study site
Krakow
Study site
Otwock, Masovian Voivodeship
Study site
Prabuty
Study site
Szczecin, West Pomeranian Voivodeship
Study site
Torun, Kuyavian-Pomeranian Voivodeship
Study site
Warsaw
United Kingdom6 sites
Study site
London
Study site
Metropolitan Borough of Wirral
Study site
Northwood
Study site
Rickmansworth
Study site
Southampton
Study site
Stevenage, Hertfordshire
Canada5 sites
Study site
Hamilton, Ontario
Study site
Kingston, Ontario
Study site
Lévis, Quebec
Study site
Montreal, Quebec
Study site
Toronto, Ontario
Hungary4 sites
Study site
Győr, Győr-Moson-Sopron
Study site
Székesfehérvár, Fejér
Study site
Szolnok, Jász-Nagykun-Szolnok
Study site
Tatabánya
About this study
Official title: Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) In Combination With Erlotinib in EGFR Wild-type Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy
- Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin.
- Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Being tested
- Patritumab, Erlotinib, Placebo
- Keywords
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Bronchogenic, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Erlotinib, Therapeutic Uses, Pharmacologic Actions, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatritumabDrug
Also called U3-1287
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)
ErlotinibDrug
Oral erlotinib 150 mg/day
PlaceboDrug
Also called Matching Placebo
Placebo infusion every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo + erlotinib | Experimental | Placebo infusion every 3 weeks and oral erlotinib 150 mg/day Receives: Drug: Erlotinib; Drug: Placebo |
| Patritumab + erlotinib | Experimental | Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day Receives: Drug: Patritumab; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Progression Free Survival (PFS) in Heregulin-high Participants
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.
Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Measured: by trial termination (at 20 months)
Part A: Progression Free Survival (PFS) in Heregulin-low Participants
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.
Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Measured: by trial termination (at 20 months)
Part B: Overall Survival
Percentage of participants still alive at the end of Part B
Measured: 4 years
Secondary outcomes (5)
Part A: Overall Survival in HRG High Participants
Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial
Measured: by trial termination (at 20 months)
Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants
Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial
Measured: by trial termination (at 20 months)
Part B: Key Secondary Efficacy Endpoint: PFS, TTD
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (TTD, as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.
Measured: 4 years
Part A: Objective Response Rate (ORR) in HRG High Participants
Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response (CR) or partial response (PR)
Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response [in the order of CR, PR, stable disease (SD), and progressive disease (PD)] among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.
Measured: by trial termination (at 20 months)
Part A: Objective Response Rate (ORR) in HRG Low Participants
Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response or partial response
Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response (in the order of CR, PR, SD, and PD) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.
Measured: by trial termination (at 20 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startMar 2014
- Primary completion11 Nov 2016
- Study completion11 Nov 2016
Why it stopped: Pre-defined criteria for continuation were not reached
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134015
- Sponsor's protocol ID
- U31287-A-U301
- Other IDs
- 2013-004371-12
- Acronym
- HER3-Lung
- Status last verified
- Dec 2017
- First submitted
- 8 Apr 2014
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) In Combination With Erlotinib in EGFR Wild-type Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy
- ClinicalTrials.gov ID
- NCT02134015
- Acronym / sponsor ID
- HER3-Lung / U31287-A-U301
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Bronchogenic, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pre-defined criteria for continuation were not reached
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Mar 2014
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin.
- Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + erlotinib | Experimental | Drug: Erlotinib, Drug: PlaceboPlacebo infusion every 3 weeks and oral erlotinib 150 mg/day |
| Patritumab + erlotinib | Experimental | Drug: Patritumab, Drug: ErlotinibInfusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Must be greater or equal to 20 years of age
- Must have cytologically or histologically confirmed NSCLC with either:
- Note: It is permissible to use either AJCC Version 6.0 or the AJCC Version 7.0 staging system. For sites that use AJCC Version 7.0, T4M0 patients with other ipsilateral nodules and N0-N2 are still eligible.
- If tumor histology is adenocarcinoma, must have wild-type EGFR genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (L858R) substitution.
- Must have received one or two prior lines of systemic chemotherapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
Key exclusion criteria (16 listed)
- Lung adenocarcinoma with an Anaplastic Lymphoma Kinase (ALK) gene rearrangement
- Left ventricular ejection fraction (LVEF) less than 45%
- Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
- History of corneal disease
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 |
|---|---|---|
| PatritumabAlso: U3-1287Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) | Drug | Patritumab + erlotinib |
| ErlotinibOral erlotinib 150 mg/day | Drug | Patritumab + erlotinib, Placebo + erlotinib |
| PlaceboAlso: Matching PlaceboPlacebo infusion every 3 weeks | Drug | Placebo + erlotinib |
Primary outcome
Part A: Progression Free Survival (PFS) in Heregulin-high Participants
Time frame: by trial termination (at 20 months)
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Part A: Progression Free Survival (PFS) in Heregulin-low Participants
Time frame: by trial termination (at 20 months)
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Part B: Overall Survival
Time frame: 4 years
Percentage of participants still alive at the end of Part B
5 secondary outcomes
Part A: Overall Survival in HRG High Participants
Time frame: by trial termination (at 20 months)
Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants
Time frame: by trial termination (at 20 months)
Part B: Key Secondary Efficacy Endpoint: PFS, TTD
Time frame: 4 years
Part A: Objective Response Rate (ORR) in HRG High Participants
Time frame: by trial termination (at 20 months)
Part A: Objective Response Rate (ORR) in HRG Low Participants
Time frame: by trial termination (at 20 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- 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.
Global Clinical Leader study director
Daiichi Sankyo
98 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Patritumab and Erlotinib in people with Lung Cancer and Non-small Cell Lung Cancer, run by Daiichi Sankyo at 98 sites in 10 countries.
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 16 inclusion and 16 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, Germany, Italy, Spain, Belgium and 5 more countries. 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 23 Jan 2018). 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?
Part A: Progression Free Survival (PFS) in Heregulin-high Participants (time frame: by trial termination (at 20 months)). The study lists 3 primary outcomes in all. 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 23 Jan 2018.