Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours\[RECIST\] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.
Interventions
afatinib (BIBW 2992) po QD
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer\[NSCLC\] 2. Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen 3. A known wild-type EGFR status 4. Patients 18 years of age or older
Exclusion criteria
1. More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease 2. Prior treatment with EGFR targeting small molecules or antibodies 3. Radiotherapy or surgery within 4 weeks prior to study entry 4. Active brain metastasis 5. Known pre-existing interstitial lung disease 6. History or presence of clinically relevant cardiovascular abnormalities 7. Cardiac left ventricular function with resting ejection fraction of less than 50% 8. Absolute neutrophil count\[ANC\] \< 1,500/mm3 9. Platelet count \<100,000/mm3 10. Creatinine clearance\<60ml/min or serum creatinine \>1.5 times upper limit of normal 11. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial 12. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Best Objective Response | Baseline till progression or death | Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Control (DC) | Baseline till progression or death | Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1. |
| Progression Free Survival (PFS) Time | Baseline till end of study or death | PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death |
| Duration of Disease Control (DC) | Baseline till progression or death | Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1). |
| Time to OR | Baseline till progression or death | The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria. |
| Duration of OR | Baseline till progression or death | Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Afatinib 40 mg Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not entered | 4 |
| Overall Study | Not treated | 1 |
| Overall Study | Other Adverse Event | 8 |
| Overall Study | Progressive disease | 34 |
Baseline characteristics
| Characteristic | Afatinib 40 mg |
|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 7.1 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 42 |
| serious Total, serious adverse events | 17 / 42 |
Outcome results
Primary
Percentage of Participants With Best Objective Response
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).
Time frame: Baseline till progression or death
Population: FAS (Full Analysis Set). The FAS consisted of all treated patients, excluding any patients found not be EGFR mutation negative according to central laboratory testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Afatinib 40 mg | Percentage of Participants With Best Objective Response | 0 Percentage of participants |
Secondary
Duration of Disease Control (DC)
Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).
Time frame: Baseline till progression or death
Population: FAS - Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Afatinib 40 mg | Duration of Disease Control (DC) | 19.29 weeks |
Secondary
Duration of OR
Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
Time frame: Baseline till progression or death
Secondary
Percentage of Participants With Disease Control (DC)
Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.
Time frame: Baseline till progression or death
Population: FAS - Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Afatinib 40 mg | Percentage of Participants With Disease Control (DC) | 24 Percentage of participants |
Secondary
Progression Free Survival (PFS) Time
PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death
Time frame: Baseline till end of study or death
Population: FAS - Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Afatinib 40 mg | Progression Free Survival (PFS) Time | 4.07 Weeks |
Secondary
Time to OR
The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.
Time frame: Baseline till progression or death