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

NCT02271906 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2013-0305NCI-2015-00357
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if it is tolerable for patients with NSCLC to receive afatinib before surgery. The safety of this drug will also be studied.

Conditions

Lung Cancer

Keywords

Lung Cancer; Non small cell lung cancer; NSCLC; Adenocarcinoma; Squamous cell carcinoma; BIBW 2992; Afatinib

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Treatment "Completed"

  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.

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

Secondary Outcomes (1)

• Number of Participants With a Change in Standard Uptake Value (SUV) From Pre to Post Operative PET-CT

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

Study Arms (1)

BIBW 2992

EXPERIMENTAL

BIBW 2992 40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.

Drug: BIBW 2992

Interventions

BIBW 2992 DRUG

40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.

BIBW 2992

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed NSCLC, who are deemed to be surgical candidates by standard criteria. Patients with all types of NSCLC (e.g., adenocarcinoma, squamous cell carcinoma) will be allowed to enroll.
• Patients with Stage IA to IIB disease. Select patients with resectable stage IIIA disease (T3N1, T4N0, T4N1) will also be eligible if approved by the PI.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Measurable disease by RECIST 1.1 criteria
• Mediastinoscopy and/or Endoscopic Bronchial Ultrasound (EBUS) and/or Endoscopic Ultrasound (EUS) for complete surgical staging when clinically indicated
• Serious, active infections must be controlled. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved.
• A signed informed consent document (ICD)
• Patients 18 years or older
• Able and willing to take oral medications

You may not qualify if:

• Known preexisting interstitial lung disease, interstitial pulmonary fibrosis, or connective tissue disorder associated lung disease
• Known N2 nodal disease or distant metastatic disease
• History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
• Patients with any of the following lab values at screening should be excluded: Absolute neutrophil count (ANC) \< 1500 / mm\^3; Platelet count \< 100,000 / mm\^3; Serum creatinine \>/= 1.5 times the upper normal limit or calculated/measured creatinine clearance \</= 60 mL/min; Bilirubin \>/=1.5mg/dL (\> 26 mol/L, SI unit equivalent); Aspartate amino transferase (AST) or Alanine amino transferase (ALT) \>/= three (3) times the upper limit of normal.
• Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
• Known or suspected active drug or alcohol abuse
• Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom for example Crohn's disease, malabsorption or CTC grade \>/= 2 diarrhea of any etiology.
• Baseline (\< 1 month before treatment) cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
• Patients receiving other investigational agent.
• History of allergic reactions to anilinoquinazolins like gefitinib, erlotinib, or BIBW2992
• Uncontrolled intercurrent illness that would preclude a patient from undergoing surgery
• Psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant (positive pregnancy test) or lactating
• Inability to comply with study and/or follow-up procedures
• Patients who are not surgical candidates or refuse surgery

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Carcinoma, Squamous Cell

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: George Simon, MD
• Organization: UT MD Anderson Cancer Center

GSimon@mdanderson.org

713-792-7734

Study Officials

• George Simon, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 22, 2014
• Study Start: July 1, 2015
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: April 30, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04

Locations

US (1)