Comparison · NCT01523587-82d19343
Afatinib vs Erlotinib: Number of Participants With Objective Response According to RECIST 1.1
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Afatinib vs Erlotinib: Number of Participants With Objective Response According to RECIST 1.1. Trial comparisons, record NCT01523587-82d19343. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01523587-82d19343
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0553 | 0.0368 | 0.0823 | wilson | |
| Risk in group 2 | 0.0277 | 0.0155 | 0.0489 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0276 | -0.000578 | 0.0572 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.99 | 0.981 | 4.06 | log | |
| Odds ratio, group 1 over group 2 | 2.05 | 0.982 | 4.29 | log | |
| Number needed to treat, for one more participant with the outcome on Afatinib than on Erlotinib | 36.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Afatinib | Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events. | 22 | 398 | OG000 |
| Group 2 | Erlotinib | Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events. | 11 | 397 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Objective Response According to RECIST 1.1
- Description
A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Time frame
- First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
- Population
- RS
Source ClinicalTrials.gov
Trial
- Title
- LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
- NCT number
- NCT01523587
- Phases
- PHASE3
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- afatinib, erlotinib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2014-11-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01523587?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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