Comparison · NCT03157089-63a491d9
Afatinib 40 mg + Pembrolizumab 200 mg vs Afatinib 30 mg + Pembrolizumab 200 mg: Duration of Objective Response (DOR)
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. Afatinib 40 mg + Pembrolizumab 200 mg vs Afatinib 30 mg + Pembrolizumab 200 mg: Duration of Objective Response (DOR). Trial comparisons, record NCT03157089-63a491d9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03157089-63a491d9
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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 | 1 | 0.342 | 1 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.658 | 0.793 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 40 mg + Pembrolizumab 200 mg | 40 milligram (mg) of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles. | 2 | 2 | OG000 |
| Group 2 | Afatinib 30 mg + Pembrolizumab 200 mg | 30 mg of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles. | 1 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Duration of Objective Response (DOR)
- Description
For participants who showed objective response, duration of objective response (DoR), was defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression (PD) or death. Tumour response was assessed based on local radiological image (CT or MRI) evaluation by the investigators according to RECIST version 1.1. The number of participants with objective response who experienced the event disease progression or death (whichever came first) is reported instead of a metric summarizing the time-to-event data with unit of time, as the number analyzed was too small to perform a Kaplan-Meier-analysis.
- Time frame
- Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 436 days.
- Population
- All participants who received at least one dose of afatinib or pembrolizumab and showed objective response.
Source ClinicalTrials.gov
Trial
- Title
- Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung
- NCT number
- NCT03157089
- Phases
- PHASE2
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Afatinib, pembrolizumab
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2021-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03157089?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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