18 and older, any sex, with Carcinoma, Non-Small-Cell Lung or Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free SurvivalPrimary· 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.
Group
Value
95% CI
Afatinib 40 Milligram (mg)
11.01
9.66 – 13.73
Gemcitabine / Cisplatin Chemotherapy
5.59
4.67 – 6.70
Objective Response (OR)Secondary· 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 Pea
Group
Value
95% CI
Afatinib 40 Milligram (mg)
67.8
61.5 – 73.6
Gemcitabine / Cisplatin Chemotherapy
23.0
15.8 – 31.4
Disease Control (DC)Secondary· 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.
Group
Value
95% CI
Afatinib 40 Milligram (mg)
92.6
88.5 – 95.5
Gemcitabine / Cisplatin Chemotherapy
76.2
67.7 – 83.5
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Afatinib 40 Milligram (mg)
23.10
20.40 – 27.33
Gemcitabine / Cisplatin Chemotherapy
23.46
17.94 – 25.56
Time to Objective Response (OR)Secondary· 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.
By Week 6
Group
Value
95% CI
Afatinib 40 Milligram (mg)
49.2
Gemcitabine / Cisplatin Chemotherapy
13.1
By Week 12
Group
Value
95% CI
Afatinib 40 Milligram (mg)
59.9
Gemcitabine / Cisplatin Chemotherapy
19.7
By Week 18
Group
Value
95% CI
Afatinib 40 Milligram (mg)
64.0
Gemcitabine / Cisplatin Chemotherapy
23.0
By Week 24
Group
Value
95% CI
Afatinib 40 Milligram (mg)
64.9
Gemcitabine / Cisplatin Chemotherapy
23.0
By Week 30
Group
Value
95% CI
Afatinib 40 Milligram (mg)
65.7
Gemcitabine / Cisplatin Chemotherapy
23.0
By Week 36
Group
Value
95% CI
Afatinib 40 Milligram (mg)
66.1
Gemcitabine / Cisplatin Chemotherapy
23.0
By Week 42
Group
Value
95% CI
Afatinib 40 Milligram (mg)
66.5
Gemcitabine / Cisplatin Chemotherapy
23.0
By Week 48
Group
Value
95% CI
Afatinib 40 Milligram (mg)
66.5
Gemcitabine / Cisplatin Chemotherapy
23.0
Duration of Objective ResponseSecondary· 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.
Group
Value
95% CI
Afatinib 40 Milligram (mg)
9.72
8.34 – 12.45
Gemcitabine / Cisplatin Chemotherapy
4.27
2.76 – 5.75
Duration of Disease ControlSecondary· 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.
Group
Value
95% CI
Afatinib 40 Milligram (mg)
11.07
9.69 – 13.80
Gemcitabine / Cisplatin Chemotherapy
5.65
5.49 – 6.93
Tumour ShrinkageSecondary· 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.
T
Group
Value
95% CI
Afatinib 40 Milligram (mg)
33.41
± 0.99
Gemcitabine / Cisplatin Chemotherapy
47.06
± 1.45
Change From Baseline in Body WeightSecondary· 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.
Change from baseline at lowest value
Group
Value
95% CI
Afatinib 40 Milligram (mg)
-3.03
± 3.99
Gemcitabine / Cisplatin Chemotherapy
-1.52
± 3.65
Change from baseline at last value
Group
Value
95% CI
Afatinib 40 Milligram (mg)
-0.76
± 4.79
Gemcitabine / Cisplatin Chemotherapy
0.00
± 4.52
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)Secondary· 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
ECOG PS 0 (baseline) 0 (last value)
Group
Value
95% CI
Afatinib 40 Milligram (mg)
11.4
Gemcitabine / Cisplatin Chemotherapy
21.8
ECOG PS 1 (baseline) 0 (last value)
Group
Value
95% CI
Afatinib 40 Milligram (mg)
6.8
Gemcitabine / Cisplatin Chemotherapy
3.6
ECOG PS 0 (baseline) 1 (last value)
Group
Value
95% CI
Afatinib 40 Milligram (mg)
8.0
Gemcitabine / Cisplatin Chemotherapy
14.5
ECOG PS 1 (baseline) 1 (last value)
Group
Value
95% CI
Afatinib 40 Milligram (mg)
67.5
Gemcitabine / Cisplatin Chemotherapy
51.8
ECOG PS 0 (baseline) 2 (last value)
Group
Value
95% CI
Afatinib 40 Milligram (mg)
0.4
Gemcitabine / Cisplatin Chemotherapy
0.0
ECOG PS 1 (baseline) 2 (last value)
Group
Value
95% CI
Afatinib 40 Milligram (mg)
2.1
Gemcitabine / Cisplatin Chemotherapy
1.8
ECOG PS 0 (baseline) 3 (last value)
Group
Value
95% CI
Afatinib 40 Milligram (mg)
0.0
Gemcitabine / Cisplatin Chemotherapy
0.0
ECOG PS 1 (baseline) 3 (last value)
Group
Value
95% CI
Afatinib 40 Milligram (mg)
2.1
Gemcitabine / Cisplatin Chemotherapy
4.5
Health Related Quality of Life (HRQOL): Time of Deterioration in CoughingSecondary· Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1.
Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at
Group
Value
95% CI
Afatinib 40 Milligram (mg)
31.05
17.45 – NA
Gemcitabine / Cisplatin Chemotherapy
10.28
4.63 – NA
Health Related Quality of Life (HRQOL): Time of Deterioration in DyspnoeaSecondary· Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8.
Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having de
Group
Value
95% CI
Afatinib 40 Milligram (mg)
7.66
4.76 – 11.17
Gemcitabine / Cisplatin Chemotherapy
1.68
1.38 – 3.15
Adverse events — posted to ClinicalTrials.gov
Time frame: From first administration of study medication until 28 days after the last administration of study medication up to 374 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Afatinib 40 Milligram (mg)
Serious: 40/239 (17%)
Deaths: 16/239
Gemcitabine / Cisplatin Chemotherapy
Serious: 12/113 (11%)
Deaths: 3/113
Serious adverse events (61 terms)
Reaction
System
Afatinib 40 Milligram (mg)
Gemcitabine / Cisplatin Ch…
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Headache
Nervous system disorders
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Pneumonia
Infections and infestations
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 14 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01121393.