Comparison · NCT01101334-a3cab901
CS-7017 Plus Erlotinib vs Erlotinib: Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CS-7017 Plus Erlotinib vs Erlotinib: Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy. Trial comparisons, record NCT01101334-a3cab901. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01101334-a3cab901
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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 | 0.205 | 0.112 | 0.345 | wilson | |
| Risk in group 2 | 0.2 | 0.109 | 0.338 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00455 | -0.162 | 0.172 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.448 | 2.33 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.366 | 2.89 | log | |
| Number needed to treat, for one more participant with the outcome on CS-7017 Plus Erlotinib than on Erlotinib | 220 | 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 | CS-7017 Plus Erlotinib | Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily. | 9 | 44 | OG000 |
| Group 2 | Erlotinib | Participants who received one 150 mg erlotinib tablet administered once daily. | 9 | 45 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
- Description
The overall response rate (ORR) was defined as the proportion of participants who achieved best overall response of complete response (CR) or partial response (PR); ORR = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
- Time frame
- Baseline to disease progression or death, up to approximately 2.5 years
- Population
- ORR was assessed in the Full Analysis Set.
Source ClinicalTrials.gov
Trial
- Title
- Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
- NCT number
- NCT01101334
- Phases
- PHASE2
- Conditions
- Advanced Non-small Cell Lung Cancer (NSCLC)
- Interventions
- CS-7017, erlotinib
- Lead sponsor
- Daiichi Sankyo
- Results first posted
- 2020-06-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01101334?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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