Trial · NCT00073008
A Study Of Oral GW572016 In Advanced Or Metastatic Non-Small Cell Lung Cancer
NCT00073008, Phase 2, Terminated, GlaxoSmithKline; results first posted 2010-01-06
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ConductScience Library. A Study Of Oral GW572016 In Advanced Or Metastatic Non-Small Cell Lung Cancer. Trials, record NCT00073008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00073008
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Oral GW572016 In Advanced Or Metastatic Non-Small Cell Lung Cancer
- NCT number
- NCT00073008
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Lung Cancer, Non-Small Cell
- Interventions
- GW572016 (lapatinib)
- First posted
- 2003-11-17
- Last updated
- 2017-02-28
- Results first posted
- 2010-01-06
- Limitations and caveats
Based on interim analysis and predefined stopping rules for futility, the study was discontinued due to lack of efficacy. At that time, no additional participants were added; enrolled participants could continue on treatment, following the protocol.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response in the Targeted Population Through the End of Treatment | Baseline and then every 8 weeks through end of treatment | Disease progression and tumor response (number of participants achieving a complete response \[CR\] or partial response \[PR\]), using standardized criteria (Response evaluation criteria in solid tumors). CR, disappearance of all target lesions; PR, 30% decrease in the sum of the longest diameter of target lesions; progressive disease, 20% increase in the sum of the longest diameter of target lesions; stable disease, small changes that do not meet above criteria. Disease assessment was done at baseline and then every 8 weeks after starting treatment, until the participant discontinued treatment. |
| Secondary | Progression-free Survival (PFS) at Four Months in the Targeted Population | From randomization and then every 8 weeks up to four months | Percentage of participants in the Targeted Population, at 4 months after starting study drug, who were alive and without disease progression. |
| Secondary | Progression-free Survival (PFS) at Four Months in the Non-Targeted Population | From randomization and then every 8 weeks up to four months | Percentage of participants in the Non-Targeted Population, at 4 months after starting study drug, who were alive and without disease progression. |
| Secondary | The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue | From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples | To further characterize the participant population, these biomarkers could be tested: serum levels of ErbB1 and ErbB2; intra-tumoral expression of ErbB1, ErbB2, etc.; mutations in ErbB1, ErbB2, and k-ras. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, serum biomarkers were not analyzed. |
| Secondary | Pharmacokinetics (PK) of Lapatinib | From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug | To characterize the PK (absorption, distribution, metabolism, and excretion) of the study drug lapatinib in the participant population. PK is defined as the concentration of drug in a participant's blood at certain time points after the drug was taken by mouth. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacokinetics were not analyzed. |
| Secondary | Pharmacogenetics (PgX) | From randomization at every 4-week assessment through end of treatment | To (1) investigate the relationship between genetic variants in specific genes and the absorption, distribution, metabolism, and excretion (pharmacokinetics) of lapatinib, and to (2) investigate the relationship between genetic variants in select genes in DNA and the response (safety, efficacy, and tolerability) to lapatinib. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacogenetics were not analyzed. |
| Secondary | Quality of Life | Baseline and then every 4 weeks through end of treatment | Standard survey forms were completed by the participant at scheduled assessments to find out how the participant felt while on study. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, quality of life was not analyzed. |
| Secondary | Time to Response | From randomization and then every 8 weeks to time of response to study drug | Time from randomization until first documented evidence of partial or complete tumor response, measured using standard criteria (RECIST). Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to response was not analyzed. |
| Secondary | Duration of Response | Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death | For those participants who show a complete or partial response, duration of response would be time from first documented evidence of response (complete or partial response by RECIST) until disease progression or death, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, duration of response was not analyzed. |
| Secondary | Time to Tumor Progression | From randomization and then every 8 weeks to disease progression or death | Time from randomization until the first documented sign of disease progression or death due to any cause, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to tumor progression was not analyzed. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response in the Targeted Population Through the End of Treatment | Baseline and then every 8 weeks through end of treatment | Targeted Population: all randomized participants who received at least one dose of study drug and had either the histological subtypes of adenocarcinoma with bronchioloalveolar carcinoma features or pure bronchioloalveolar carcinoma, or were never smokers with any histology of non-small cell lung cancer (NSCLC) | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Tumor Response in the Non-Targeted Population Through the End of Treatment | Baseline and then every 8 weeks through end of treatment | Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population. | participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) at Four Months in the Targeted Population | From randomization and then every 8 weeks up to four months | Targeted Population | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) at Four Months in the Non-Targeted Population | From randomization and then every 8 weeks up to four months | Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population. | percentage of participants | NUMBER |
| SECONDARY | The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue | From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples | |||
| SECONDARY | Pharmacokinetics (PK) of Lapatinib | From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug | |||
| SECONDARY | Pharmacogenetics (PgX) | From randomization at every 4-week assessment through end of treatment | |||
| SECONDARY | Quality of Life | Baseline and then every 4 weeks through end of treatment | |||
| SECONDARY | Time to Response | From randomization and then every 8 weeks to time of response to study drug | |||
| SECONDARY | Duration of Response | Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 1500 mg QD | Complete response | 0 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 500 mg BID | Complete response | 0 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 1500 mg QD | Partial response | 0 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 500 mg BID | Partial response | 0 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 1500 mg QD | Stable disease | 5 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 500 mg BID | Stable disease | 9 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 1500 mg QD | Progressive disease | 18 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 500 mg BID | Progressive disease | 20 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 1500 mg QD | Missing | 1 | participants | |
| Tumor Response in the Targeted Population Through the End of Treatment | Lapatinib 500 mg BID | Missing | 3 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lapatinib 1500 mg QD | 65 | |
| Overall Study | STARTED | Lapatinib 500 mg BID | 66 | |
| Overall Study | COMPLETED | Lapatinib 1500 mg QD | 3 | |
| Overall Study | COMPLETED | Lapatinib 500 mg BID | 3 | |
| Overall Study | NOT COMPLETED | Lapatinib 1500 mg QD | 62 | |
| Overall Study | NOT COMPLETED | Lapatinib 500 mg BID | 63 |
Source ClinicalTrials.gov
Adverse events172
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Lapatinib 1500 mg QD | 39 | 65 | |
| other | Diarrhea | Gastrointestinal disorders | Lapatinib 500 mg BID | 33 | 66 | |
| other | Rash | Skin and subcutaneous tissue disorders | Lapatinib 1500 mg QD | 31 | 65 | |
| other | Rash | Skin and subcutaneous tissue disorders | Lapatinib 500 mg BID | 27 | 66 | |
| other | Fatigue | General disorders | Lapatinib 1500 mg QD | 24 | 65 | |
| other | Fatigue | General disorders | Lapatinib 500 mg BID | 20 | 66 | |
| other | Nausea | Gastrointestinal disorders | Lapatinib 1500 mg QD | 25 | 65 | |
| other | Nausea | Gastrointestinal disorders | Lapatinib 500 mg BID | 16 | 66 | |
| other | Anorexia | Metabolism and nutrition disorders | Lapatinib 1500 mg QD | 17 | 65 | |
| other | Anorexia | Metabolism and nutrition disorders | Lapatinib 500 mg BID | 15 | 66 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lapatinib 1500 mg QD | ||
| Total, all-cause mortality | Lapatinib 500 mg BID | ||
| Total, other adverse events | Lapatinib 1500 mg QD | 64 | 65 |
| Total, other adverse events | Lapatinib 500 mg BID | 63 | 66 |
| Total, serious adverse events | Lapatinib 1500 mg QD | 15 | 65 |
| Total, serious adverse events | Lapatinib 500 mg BID | 17 | 66 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20215545 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lapatinib 1500 mg QD vs Lapatinib 500 mg BID: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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