Trial Outcomes & Findings for The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting (NCT NCT02271906)

NCT ID: NCT02271906

Last Updated: 2019-04-30

Results Overview

A patient is declared to have the treatment "completed" if he completes at least 14 days of neoadjuvant treatment, had a thoracotomy for the planned surgical resection, and 30 days of post operative care.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

From the start of neoadjuvant treatment to 30 days post operative care

Results posted on

2019-04-30

Participant Flow

Two patients with untreated resectable Stage IA to IIIA non-small cell lung cancer were recruited at the University of Texas MD Anderson Cancer Center.

Following registration, patients should begin protocol treatment within 2 weeks. If a patient does not receive protocol therapy within 2 weeks following registration, the patient's registration on the study may be canceled at the discretion of the study investigators and the patient will be considered a screen failure.

Participant milestones

Participant milestones
Measure	Afatinib Single Agent Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Afatinib Single Agent n=2 Participants Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of neoadjuvant treatment to 30 days post operative care

Outcome measures

Outcome measures
Measure	Afatinib Single Agent n=2 Participants Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
Number of Patients With Treatment "Completed" Treatment Completed	2 Participants
Number of Patients With Treatment "Completed" Treatment Not Completed	0 Participants

SECONDARY outcome

Timeframe: From the start of neoadjuvant treatment to follow-up, up to 30 days post surgery

To determine whether pre-operative Afatinib treatment affects metabolic tumor labeling, as measured by PET-CT scanning.

Outcome measures

Outcome measures
Measure	Afatinib Single Agent n=2 Participants Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
Number of Participants With a Change in Standard Uptake Value (SUV) From Pre to Post Operative PET-CT Increase in percentage change	1 Participants
Number of Participants With a Change in Standard Uptake Value (SUV) From Pre to Post Operative PET-CT Decrease in percentage change	1 Participants

Adverse Events

Afatinib Single Agent

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Afatinib Single Agent n=2 participants at risk Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 1/2 • Number of events 1 • From the start of neoadjuvant treatment to 30 days post operative care The grades 1-3 adverse events which were recorded after registration were included
Gastrointestinal disorders Diarrhea	100.0% 2/2 • Number of events 5 • From the start of neoadjuvant treatment to 30 days post operative care The grades 1-3 adverse events which were recorded after registration were included
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 1/2 • Number of events 1 • From the start of neoadjuvant treatment to 30 days post operative care The grades 1-3 adverse events which were recorded after registration were included
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 1/2 • Number of events 1 • From the start of neoadjuvant treatment to 30 days post operative care The grades 1-3 adverse events which were recorded after registration were included
General disorders Fatigue	50.0% 1/2 • Number of events 1 • From the start of neoadjuvant treatment to 30 days post operative care The grades 1-3 adverse events which were recorded after registration were included
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • From the start of neoadjuvant treatment to 30 days post operative care The grades 1-3 adverse events which were recorded after registration were included
Skin and subcutaneous tissue disorders Rash acneiform	100.0% 2/2 • Number of events 2 • From the start of neoadjuvant treatment to 30 days post operative care The grades 1-3 adverse events which were recorded after registration were included

Additional Information

George Simon, MD

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place