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]

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003899
• Other study ID #: 1200.72
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2009
• Last updated: December 5, 2013
• Start date: October 2009

Study information

• Verified date: August 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea, Republic of: Korea Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• afatinib (BIBW 2992)
afatinib (BIBW 2992) po QD

Locations

Country	Name	City	State
Korea, Republic of	1200.72.8201 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1200.72.8202 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1200.72.8203 Boehringer Ingelheim Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline till progression or death	No
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.	Baseline till progression or death	No
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	Baseline till end of study or death	No
Secondary	Duration of Disease Control (DC)	Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).	Baseline till progression or death	No
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.	Baseline till progression or death	No
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.	Baseline till progression or death	No

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