Clinical trial · Interventional
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]
A Phase II Trial of BIBW 2992 as a Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type EGFR
NCT01003899CI-TRIAL-00013264completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| afatinib (BIBW 2992) | Drug | Afatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- afatinib (BIBW 2992)
- description
- patient to receive afatinib(BIBW 2992) po QD in an open-label manner
- interventionNames
- Drug: afatinib (BIBW 2992)
Primary outcomes (1)
- measure
- Percentage of Participants With Best Objective Response
- timeFrame
- Baseline till progression or death
- description
- Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).
Secondary outcomes (5)
- measure
- Percentage of Participants With Disease Control (DC)
- timeFrame
- Baseline till progression or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAhn MJ, Kim SW, Cho BC, Ahn JS, Lee DH, Sun JM, Massey D, Kim M, Shi Y, Park K. Phase II study of Afatinib as third-line treatment for patients in Korea with stage IIIB/IV non-small cell lung cancer harboring wild-type EGFR. Oncologist. 2014 Jul;19(7):702-3. doi: 10.1634/theoncologist.2013-0419. Epub 2014 May 27. PMID 24868099