Trial · NCT01121393
BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
NCT01121393, Phase 3, Completed, Boehringer Ingelheim; results first posted 2015-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC). Trials, record NCT01121393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01121393
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT01121393
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 364 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Interventions
- Gemcitabine+Cisplatin, BIBW 2992
- First posted
- 2010-05-12
- Last updated
- 2018-12-14
- Results first posted
- 2015-01-26
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168 | The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS. Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates. |
| Secondary | Objective Response (OR) | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR. CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions. PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions. (Exact 95% Confidence interval by Clopper and Pearson.) |
| Secondary | Disease Control (DC) | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC. |
| Secondary | Overall Survival (OS) | From randomisation up to 374 weeks | OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date. Median time results from unstratified Kaplan-Meier estimates. |
| Secondary | Time to Objective Response (OR) | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1. For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response. Outcome data are the percentage of patients with OR by each scheduled tumour assessment. |
| Secondary | Duration of Objective Response | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1. For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates. |
| Secondary | Duration of Disease Control | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates. |
| Secondary | Tumour Shrinkage | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline. The means are adjusted for baseline sum of lesions and EGFR mutation category. |
| Secondary | Change From Baseline in Body Weight | Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks. | The change from baseline to the lowest and the last body weight recorded or during the the study. |
| Secondary | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks. | The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status. ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work; 2. Ambulatory (\>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities; 3. Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours; 4. Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5. Dead |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168 | The randomised set (RS) included all patients randomised to receive treatment, whether treated or not. | months | MEDIAN |
| SECONDARY | Objective Response (OR) | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | The randomised set. | percentage of participants | NUMBER |
| SECONDARY | Disease Control (DC) | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | The randomised set. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From randomisation up to 374 weeks | The randomised set. | months | MEDIAN |
| SECONDARY | Time to Objective Response (OR) | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | The RS included all patients randomised to receive treatment, whether treated or not. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | The Randomised set with an objective response. | months | MEDIAN |
| SECONDARY | Duration of Disease Control | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | The randomised set with disease control. | months | MEDIAN |
| SECONDARY | Tumour Shrinkage | Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374 | The randomised set. There were ony 220 patients in the Afatinib arm and 101 patients in the Gemcitabine / Cisplatin arm with baseline and post-baseline target lesion measurements. | millimetre (mm) | MEAN |
| SECONDARY | Change From Baseline in Body Weight | Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks. | The randomised set. Data only presented for a patient with a baseline and at least on post-baseline assessment of weight. | kilogram (kg) | MEAN |
| SECONDARY | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks. | The randomised set. Data only presented for patients with a baseline and at least one post-baseline assessment of ECOG status. | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Afatinib 40 Milligram (mg) | 11.01 | 95% Confidence Interval 9.66 to 13.73 | months | |
| Progression-free Survival | Gemcitabine / Cisplatin Chemotherapy | 5.59 | 95% Confidence Interval 4.67 to 6.70 | months | |
| Objective Response (OR) | Afatinib 40 Milligram (mg) | 67.8 | 95% Confidence Interval 61.5 to 73.6 | percentage of participants | |
| Objective Response (OR) | Gemcitabine / Cisplatin Chemotherapy | 23.0 | 95% Confidence Interval 15.8 to 31.4 | percentage of participants | |
| Disease Control (DC) | Afatinib 40 Milligram (mg) | 92.6 | 95% Confidence Interval 88.5 to 95.5 | percentage of participants | |
| Disease Control (DC) | Gemcitabine / Cisplatin Chemotherapy | 76.2 | 95% Confidence Interval 67.7 to 83.5 | percentage of participants | |
| Overall Survival (OS) | Afatinib 40 Milligram (mg) | 23.10 | 95% Confidence Interval 20.40 to 27.33 | months | |
| Overall Survival (OS) | Gemcitabine / Cisplatin Chemotherapy | 23.46 | 95% Confidence Interval 17.94 to 25.56 | months | |
| Time to Objective Response (OR) | Afatinib 40 Milligram (mg) | By Week 6 | 49.2 | percentage of participants | |
| Time to Objective Response (OR) | Gemcitabine / Cisplatin Chemotherapy | By Week 6 | 13.1 | percentage of participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Afatinib 40 Milligram (mg) | 242 | |
| Overall Study | STARTED | Gemcitabine / Cisplatin Chemotherapy | 122 | |
| Overall Study | Treated | Afatinib 40 Milligram (mg) | 239 | |
| Overall Study | Treated | Gemcitabine / Cisplatin Chemotherapy | 113 | |
| Overall Study | COMPLETED | Afatinib 40 Milligram (mg) | 0 | |
| Overall Study | COMPLETED | Gemcitabine / Cisplatin Chemotherapy | 38 | |
| Overall Study | NOT COMPLETED | Afatinib 40 Milligram (mg) | 242 | |
| Overall Study | NOT COMPLETED | Gemcitabine / Cisplatin Chemotherapy | 84 |
Source ClinicalTrials.gov
Adverse events228
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 | Anaemia | Blood and lymphatic system disorders | Afatinib 40 Milligram (mg) | 23 | 239 | |
| other | Anaemia | Blood and lymphatic system disorders | Gemcitabine / Cisplatin Chemotherapy | 31 | 113 | |
| other | Leukopenia | Blood and lymphatic system disorders | Afatinib 40 Milligram (mg) | 17 | 239 | |
| other | Leukopenia | Blood and lymphatic system disorders | Gemcitabine / Cisplatin Chemotherapy | 58 | 113 | |
| other | Neutropenia | Blood and lymphatic system disorders | Afatinib 40 Milligram (mg) | 13 | 239 | |
| other | Neutropenia | Blood and lymphatic system disorders | Gemcitabine / Cisplatin Chemotherapy | 61 | 113 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Afatinib 40 Milligram (mg) | 6 | 239 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Gemcitabine / Cisplatin Chemotherapy | 20 | 113 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Afatinib 40 Milligram (mg) | 3 | 239 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Gemcitabine / Cisplatin Chemotherapy | 7 | 113 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Afatinib 40 Milligram (mg) | 16 | 239 |
| Total, all-cause mortality | Gemcitabine / Cisplatin Chemotherapy | 3 | 113 |
| Total, other adverse events | Afatinib 40 Milligram (mg) | 236 | 239 |
| Total, other adverse events | Gemcitabine / Cisplatin Chemotherapy | 112 | 113 |
| Total, serious adverse events | Afatinib 40 Milligram (mg) | 40 | 239 |
| Total, serious adverse events | Gemcitabine / Cisplatin Chemotherapy | 12 | 113 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Afatinib 40 Milligram (mg) vs Gemcitabine / Cisplatin Chemotherapy: deaths from any cause | Trial comparisons |
| Afatinib 40 Milligram (mg) vs Gemcitabine / Cisplatin Chemotherapy: serious adverse events | 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.
GET https://conductscience.org/api/trials/v1/NCT01121393
GET https://conductscience.org/api/trials/v1/NCT01121393/results?page=2