Afatinib in NSCLC With HER2 Mutation

NCT02597946 | Completed Phase 2 Results

• 1 other identifier: 1200.222
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 9

Brief Summary

to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2 mutations, previously treated with 1 or 2 chemotherapy regimens

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Objective Response (OR) in Part A According to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1

  Percentage of patients with objective response (OR) in part A according to RECIST 1.1. Objective Response defined as patients with tumour size reduction of a predefined amount using RECIST 1.1 in part A. Objective response included both confirmed Partial Response (PR) plus Complete Response (CR) as measured by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) according to RECIST 1.1. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions asking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions.

  CT Scan at Weeks 8 & 12 (for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment , ie., up to approximately 12 Months

Secondary Outcomes (5)

• Percentage of Patients With Disease Control (DC) in Part A

  CT Scan at Weeks 8 & 12(for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment, ie up to approximately 12 Months

• Progression Free Survival (PFS) in Part A

  From the date of starting treatment of afatinib to the date of disease progression or to the date of death, ie up to approximately 12 Months

• Overall Survival (OS)

  From start of treatment of afatinib until death from any cause, ie up to approximately 12 Months

• Time to Progression (TTP) in Part A

  From the date of starting treatment of afatinib to the date of disease progression , ie up to approximately 12 Months

• Duration of Response (DOR) in Part A

  CT Scan at Weeks 8 & 12(for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment, ie up to approximately 12 Months

Study Arms (1)

all patients

EXPERIMENTAL

Part A: all enrolled patients will receive afatinib monotherapy. Part B: all eligible patients will receive afatinib combined with weekly paclitaxel.

Drug: afatinib; Drug: paclitaxel

Interventions

afatinib DRUG

all patients

paclitaxel DRUG

all patients

Eligibility Criteria

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

You may qualify if:

• Patients with Histologically or cytologically confirmed diagnosis of stage IIIb/IV NSCLC (AJCC 7.0), who had failed one or two systemic chemotherapy regimens, one of which must be platinum-based .
• Tumor tissue with HER2 mutations as confirmed by AmoyDx® HER2 Mutation Detection Kit
• Patients with at least one measurable tumor lesion that can accurately be measured by CT scan or MRI according to RECIST 1.1
• Age\>=18 years
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
• Adequate organ function
• Recovered from any previous therapy related toxicity to \<=Grade 1 at study entry (except for stable sensory neuropathy \<=Grade 2 and alopecia)
• ECOG performance score 0\~2

You may not qualify if:

• Prior treatment with Epidermal Growth Factor Receptor (EGFR) or HER2 targeting small molecules or antibodies.
• Any chemo-, or immune anticancer therapy within 4 weeks prior to start of study treatment, Hormonal treatment within 2 weeks prior to start of study treatment, Radiotherapy within 4 weeks prior to start of treatment, except as follows:
• i.) Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to enter, and ii.) Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
• Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
• Known hypersensitivity to afatinib or the excipients of any of the trial drugs
• History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of \>= 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to randomisation.
• Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug.
• Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
• Requiring treatment with any of the prohibited concomitant medications
• Known pre-existing interstitial lung disease.
• Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug.
• Active hepatitis B infection and/or active hepatitis C infection and/or known HIV carrier.
• Leptomeningeal carcinomatosis.
• Symptomatic brain metastases; To be eligible patients must be asymptomatic from brain metastases at least 4 weeks without requirement for steroids or anti-epileptic therapy.
• Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control for the duration of study participation and for at least 2 weeks after treatment has ended.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (9)

Hunan Province Tumor Hospital

Changsha, 410013, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

The Second Affiliated Hospital to Nanchang University

Nanchang, 330006, China

Location

First Hospital Affiliated with Nanjing Medical University

Nanjing, 210029, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Limitations and Caveats

No patients met the criteria to enter Part B. Thus planned Part B was not performed in this trial.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 5, 2015
• Study Start: March 18, 2016
• Primary Completion: July 22, 2018
• Study Completion: July 22, 2018
• Last Updated: February 19, 2025
• Results First Posted: October 1, 2019

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8); MY (1)