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]

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: afatinib (BIBW 2992)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01003899

1200.72

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

afatinib (BIBW 2992)

Experimental group

Description:

patient to receive afatinib(BIBW 2992) po QD in an open-label manner

Treatment:

Drug: afatinib (BIBW 2992)