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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]

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

afatinib (BIBW 2992)

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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] < 1,500/mm3
Platelet count <100,000/mm3
Creatinine clearance<60ml/min or serum creatinine >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

Sites / Locations

1200.72.8201 Boehringer Ingelheim Investigational Site
1200.72.8202 Boehringer Ingelheim Investigational Site
1200.72.8203 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

afatinib (BIBW 2992)

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Percentage of Participants With Disease Control (DC)

Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.

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

Duration of Disease Control (DC)

Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).

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.

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.

Full Information

NCT ID

NCT01003899

First Posted

October 28, 2009

Last Updated

December 5, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01003899

Brief Title

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]

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

afatinib (BIBW 2992)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

afatinib (BIBW 2992)

Intervention Description

afatinib (BIBW 2992) po QD

Primary Outcome Measure Information:

Title

Percentage of Participants With Best Objective Response

Description

Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).

Time Frame

Baseline till progression or death

Secondary Outcome Measure Information:

Title

Percentage of Participants With Disease Control (DC)

Description

Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.

Time Frame

Baseline till progression or death

Title

Progression Free Survival (PFS) Time

Description

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

Time Frame

Baseline till end of study or death

Title

Duration of Disease Control (DC)

Description

Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).

Time Frame

Baseline till progression or death

Title

Time to OR

Description

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.

Time Frame

Baseline till progression or death

Title

Duration of OR

Description

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.

Time Frame

Baseline till progression or death

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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] < 1,500/mm3 Platelet count <100,000/mm3 Creatinine clearance<60ml/min or serum creatinine >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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1200.72.8201 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1200.72.8202 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1200.72.8203 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

24868099

Citation

Ahn 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. Erratum In: Oncologist. 2015 May;20(5):570.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1200/1200.72_U12-1542-02-DS.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1200/1200.72_Literature.pdf

Description

Related Info

Learn more about this trial

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]

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