Carcinoma, Non-Small-Cell LungPhase 3NCT00153803
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Erlotinib (tarceva) in people with Carcinoma, Non-Small-Cell Lung and Non-small Cell Lung Cancer, run by Dartmouth-Hitchcock Medical Center at 65 sites in United States.
Trial summary
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Non-small Cell Lung Cancer, NSCLC
- What is being tested?
- Erlotinib (tarceva)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 65 sitesUnited States
- Study dates
- May 2005to Apr 2014
- 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
- Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)
- No evidence of metastatic disease
- No prior treatment
- Adequate organ function
- Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)
Who cannot join
- Metastasis
- Prior treatment
- Malignant pleural or pericardial effusion
- Peripheral neuropathy >= grade 2
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
McFarland Clinic
Ames, Iowa, 50010
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Union Memorial Hospital
Baltimore, Maryland, 21218
Harbor View Cancer Center
Baltimore, Maryland, 21225
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Bay Medical Cancer Center
Bay City, Michigan, 48706
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35235
Olympic Hematology/Oncology
Bremerton, Washington, 98310
Pasco Hernando Oncology Associates
Brooksville, Florida, 34613
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Aultman Cancer Center
Canton, Ohio, 44710
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 00000
Frederick Smith, MD
Chevy Chase, Maryland, 20815
The Cleveland Clinic Foundation Hematology/Med Oncology
Cleveland, Ohio, 44195
SCOA-SC Onc Assoc
Columbia, South Carolina, 29201
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, 60007
Florida Cancer Specialists
Fort Myers, Florida, 33901
Lee Cancer Clinic
Fort Myers, Florida, 33919
Cooper Clinic
Fort Smith, Arkansas, 72913
Queens Medical Associates
Fresh Meadows, New York, 11365
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
St. Francis Hospital Cancer Center
Hartford, Connecticut, 06105
Kentucky Cancer Clinic
Hazard, Kentucky, 41701
Genesis Cancer Center
Hot Springs, Arkansas, 71913
VA Department of Hematology/Oncology
Houston, Texas, 77030
Oncology Specialties, P.C.
Huntsville, Alabama, 35801
Investigative Clinical Research of Indiana LLC
Indianapolis, Indiana, 46254
Joliet Hematology Associates
Joliet, Illinois, 60435
Jupiter Medical Center
Jupiter, Florida, 33458
Dartmouth-Hitchcock-Keene
Keene, New Hampshire, 03431
Howard Regional Health System
Kokomo, Indiana, 46904
Cancer Care of North Florida
Lake City, Florida, 32055
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Southeast Nebraska Hematology/Oncology
Lincoln, Nebraska, 68510
Connecticut Oncology Group
Middletown, Connecticut, 06457
Winthrop University Hospital
Mineola, New York, 11501
Morgantown Internal Medicine Group
Morgantown, West Virginia, 26505
George Bray Cancer Center/New Britain General Hospital
New Britain, Connecticut, 06050
Oncology and Hematology Associates, PC
New London, Connecticut, 06320
Pasco/Hernando Oncology
New Port Richey, Florida, 34652
Hematology Oncology Associates of Rockland, PC
New York, New York, 10956
Virginia Oncology Associates Research Program
Newport News, Virginia, 23606
Sussex County Medical Associates
Newton, New Jersey, 07860
Whittingham Cancer Center at Norwalk Hospital
Norwalk, Connecticut, 06856
Community Hematology Oncology
Olney, Maryland, 20832
Methodist Cancer Center
Omaha, Nebraska, 68114
Mid Florida Oncology
Orange City, Florida, 32763
MD Anderson
Orlando, Florida, 32806
Western Hematology Oncology
Paducah, Kentucky, 42003
Legacy Good Samaritan
Portland, Oregon, 97201
Northstate Cancer Speciality
Redding, California, 96001
Hope Oncology
Richardson, Texas, 75080
Mercy General Hospital
Sacramento, California, 95816
Maine Center for Cancer Medicine
Scarborough, Maine, 04074
Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center
Stamford, Connecticut, 06902
Oncology & Hematology Association of West Broward
Tamarac, Florida, 33321
Lincoln Hospital
The Bronx, New York, 10451
Blood and Cancer Center of East Texas
Tyler, Texas, 75701
Tyler Hematology/Oncology
Tyler, Texas, 75701
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
Palm Beach Cancer Institute
West Palm Beach, Florida, 33410
Veterans Administration Medical Center
White River Junction, Vermont, 05009
Fallon Clinic Hematology/ Oncology
Worcester, Massachusetts, 01608
About this study
Official title: A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).
Read the detailed description
The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.
- Being tested
- Erlotinib (tarceva), Placebo
- Keywords
- Erlotinib, Tarceva, Web based, Stage III NSCLC
- 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.
Erlotinib (tarceva)Drug
Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
PlaceboDrug
Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Erlotinib (Tarceva) 150mg: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy. Receives: Drug: Erlotinib (tarceva) |
| 2 | Placebo comparator | Matched Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.
Measured: 5 years
Secondary outcomes (4)
Overall Survival
Measured: From date of randomization until the date of death from any cause, assessed up to 50 months
Percent of Participants Surviving 3 Years
Measured: 36 months
Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation
Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.
Measured: 18 months
Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo
Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionApr 2014
- Study completionApr 2014
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 Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- James R Rigas, MD, Study chair, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153803
- Sponsor's protocol ID
- D-0410
- Status last verified
- Sep 2019
- First submitted
- 7 Sep 2005
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).
- ClinicalTrials.gov ID
- NCT00153803
- Acronym / sponsor ID
- D-0410
- Keywords
- Erlotinib, Tarceva, Web based, Stage III NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Sanofi, Genentech, Inc.
- Study start
- May 2005
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).
Detailed description
The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Erlotinib (tarceva)Erlotinib (Tarceva) 150mg: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy. |
| 2 | Placebo comparator | Drug: PlaceboMatched Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)
- No evidence of metastatic disease
- No prior treatment
- Adequate organ function
- Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)
Key exclusion criteria (4 listed)
- Metastasis
- Prior treatment
- Malignant pleural or pericardial effusion
- Peripheral neuropathy >= grade 2
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 (tarceva)Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy. | Drug | 1 |
| PlaceboMatched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy. | Drug | 2 |
Primary outcome
Progression Free Survival
Time frame: 5 years
Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.
4 secondary outcomes
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 50 months
Percent of Participants Surviving 3 Years
Time frame: 36 months
Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation
Time frame: 18 months
Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 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.
James R Rigas, MD study chair
Norris Cotton Cancer Center
65 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 (tarceva) in people with Carcinoma, Non-Small-Cell Lung and Non-small Cell Lung Cancer, run by Dartmouth-Hitchcock Medical Center at 65 sites in United States.
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 4 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States. 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. Some participants in this study may receive a placebo. 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 6 Sep 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 (time frame: 5 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 6 Sep 2019.