A Phase 3 interventional study of Erlotinib (tarceva) and Placebo in Carcinoma, Non-Small-Cell Lung, Non-small Cell Lung Cancer and NSCLC, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 65 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Dartmouth-Hitchcock Medical Center · Phase 3, Interventional, and Treatment
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).
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 245 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
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Exclusion Criteria:
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.
Drug: Erlotinib (tarceva)
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.
Drug: Placebo
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.
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.
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.
Time frame: 5 years
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
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.
Time frame: 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.
Time frame: 18 months
Period 1: 245 patients were registered \& randomized. Of those, 10 patients were ineligible due to incorrect stage, withdrawal of consent, inability to meet radiation therapy parameters, and inadequate functional status. The number of participants for each specific reason for ineligibility is unknown. They did not receive any study intervention.
| Milestone | Tarceva | Placebo |
|---|---|---|
| Started | 123 | 122 |
| Received chemoradiation | 118 | 117 |
| Completed | 118 | 117 |
| Not completed | 5 | 5 |
| Milestone | Tarceva | Placebo |
|---|---|---|
| Started | 118 | 117 |
| Investigational drug dispensed | 77 | 75 |
| Completed | 77 | 75 |
| Not completed | 41 | 42 |
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.
| Months | Tarceva | Placebo |
|---|---|---|
| Progression Free Survival | 7.4 (NA to NA) | 8.1 (NA to NA) |
| Months | Tarceva | Placebo |
|---|---|---|
| Overall Survival | 16.5 (NA to NA) | 20.3 (NA to NA) |
| percentage of participants | Tarceva | Placebo |
|---|---|---|
| Percent of Participants Surviving 3 Years | 37 | 41 |
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.
| Participants | Tarceva | Placebo |
|---|---|---|
| Death | 7 | 6 |
| Disability | 0 | 0 |
| Life-threatening | 2 | 4 |
| Hospitalization | 26 | 36 |
| Impairment/damange | 3 | 3 |
| Other | 1 | 0 |
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.
| Participants | Tarceva | Placebo |
|---|---|---|
| Death | 10 | 6 |
| Disability | 0 | 0 |
| Life-threatening | 1 | 1 |
| Hospitalization (initial or prolonged) | 30 | 23 |
| Impairment/damange | 2 | 1 |
| Other | 1 | 0 |
Collected over The intent-to-treat population included 235 eligible randomized patients to the erlotinib arm (n = 118) or placebo arm (n = 117); 245 randomized, 10 became ineligible prior to any treatment. Patients were evaluated with a medical history, physical exam, laboratory studies, and toxicity assessment starting at 1st dose, every 4 weeks for 2 months, then every 8-12 weeks until treatment discontinuation. Participants were evaluated, on average, for 6 months, and through study completion up to 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemoradiation Before Tarceva | 26/118 (22%) | 36/118 (30.5%) | 12/118 (10.2%) |
| Chemoradiation Before Placebo | 27/117 (23.1%) | 38/117 (32.5%) | 8/117 (6.8%) |
| Tarceva | 43/77 (55.8%) | 39/77 (50.6%) | 8/77 (10.4%) |
| Placebo | 40/75 (53.3%) | 23/75 (30.7%) | 0/75 (0%) |
| Event | Chemoradiation Before Tarceva | Chemoradiation Before Placebo | Tarceva | Placebo |
|---|---|---|---|---|
| Infection - OtherInfections and infestations | 2/118 | 1/117 | 5/77 | 0/75 |
| Upper Respiratory - OtherRespiratory, thoracic and mediastinal disorders | 3/118 | 3/117 | 3/77 | 4/75 |
| Infection - LungInfections and infestations | 1/118 | 0/117 | 4/77 | 1/75 |
| Pneumonitis/pulmonary infiltratesRespiratory, thoracic and mediastinal disorders | 1/118 | 2/117 | 4/77 | 0/75 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 0/118 | 2/117 | 2/77 | 3/75 |
| Thrombosis/thrombus/embolismVascular disorders | 3/118 | 4/117 | 2/77 | 0/75 |
| EsophagitisGastrointestinal disorders | 4/118 | 2/117 | 0/77 | 0/75 |
| Cardiac GeneralCardiac disorders | 0/118 | 1/117 | 2/77 | 2/75 |
| Cerebrovascular IschemiaNervous system disorders | 0/118 | 1/117 | 0/77 | 2/75 |
| Pain - BoneGeneral disorders | 0/118 | 0/117 | 2/77 | 0/75 |
| Event | Chemoradiation Before Tarceva | Chemoradiation Before Placebo | Tarceva | Placebo |
|---|---|---|---|---|
| Pain - Chest/ThoraxGeneral disorders | 2/118 | 0/117 | 0/77 | 0/75 |
| Constitutional symptoms - FeverGeneral disorders | 1/118 | 0/117 | 1/77 | 0/75 |
| FractureMusculoskeletal and connective tissue disorders | 0/118 | 1/117 | 1/77 | 0/75 |
| DesquamationSkin and subcutaneous tissue disorders | 0/118 | 0/117 | 1/77 | 0/75 |
| PancreatitisHepatobiliary disorders | 0/118 | 0/117 | 1/77 | 0/75 |
| Pain - Abdomen NOSGeneral disorders | 0/118 | 0/117 | 1/77 | 0/75 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/118 | 0/117 | 1/77 | 0/75 |
| Upper respiratory - otherRespiratory, thoracic and mediastinal disorders | 0/118 | 0/117 | 1/77 | 0/75 |
| EmbolismVascular disorders | 0/118 | 0/117 | 1/77 | 0/75 |
| HemoglobinBlood and lymphatic system disorders | 1/118 | 1/117 | 0/77 | 0/75 |
| Age, Continuous(years) | Tarceva | Placebo | Total |
|---|---|---|---|
| Median | 68 (39 to 89) | 67 (38 to 84) | 67.5 (38 to 89) |
| Sex: Female, Male(Participants) | Tarceva | Placebo | Total |
|---|---|---|---|
| Female | 45 | 55 | 100 |
| Male | 78 | 67 | 145 |
| Race (NIH/OMB)(Participants) | Tarceva | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 7 | 13 |
| White | 109 | 106 | 215 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 7 | 14 |
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center