Know Cancer

or
forgot password

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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is the objective tumour response rate (complete response, partial response) as determined by Response Evaluation Criteria in Solid Tumours version 1.1.

Outcome Time Frame:

78 weeks

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Korea, Republic of: Korea Food and Drug Administration

Study ID:

1200.72

NCT ID:

NCT01003899

Start Date:

October 2009

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location