Phase 2
Completed N=47
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]
Source: ClinicalTrials.gov NCT01003899 ↗Enrolled (actual)
47
Serious AEs
40.5%
Results posted
Oct 2013
Primary outcomePrimary: Percentage of Participants With Best Objective Response — 0 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Best Objective Response |
— | — |
| SECONDARY Percentage of Participants With Disease Control (DC) |
24 | — |
| SECONDARY Progression Free Survival (PFS) Time |
4.07 | — |
| SECONDARY Duration of Disease Control (DC) |
19.29 | — |
| SECONDARY Time to OR |
— | — |
| SECONDARY Duration of OR |
— | — |
Eligibility Criteria
Inclusion criteria
- Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer[NSCLC]
- Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen
- A known wild-type EGFR status
- Patients 18 years of age or older
Exclusion criteria
- More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
- Prior treatment with EGFR targeting small molecules or antibodies
- Radiotherapy or surgery within 4 weeks prior to study entry
- Active brain metastasis
- Known pre-existing interstitial lung disease
- History or presence of clinically relevant cardiovascular abnormalities
- Cardiac left ventricular function with resting ejection fraction of less than 50%
- Absolute neutrophil count[ANC] 1.5 times upper limit of normal
- 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
- Pregnancy or breast-feeding
Data sourced from ClinicalTrials.gov (NCT01003899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.