Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

NCT01953913 | Completed Phase 3 Results

• 1 other identifier: 1200.66
• Study Type: interventional
• Target: 542
• Locations: 5 countries
• Sites: 33

Brief Summary

Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Serious Adverse Events (SAEs)

  Percentage of participants with serious adverse events (SAEs).

  From first drug administration up to 28 days after last drug administration, up to 1624 days.

Secondary Outcomes (2)

• Time to Symptomatic Progression (TTSP)

  From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.

• Percentage of Participants With Drug-related (Afatinib-related) Adverse Events

  From first drug administration up to 28 days after last drug administration, up to 1624 days.

Study Arms (1)

Afatinib

EXPERIMENTAL

Patient will receive afatinib once daily

Drug: Afatinib

Interventions

Afatinib DRUG

Patient will receive afatinib once daily

Afatinib

Eligibility Criteria

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

You may qualify if:

• locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
• presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumor biopsy
• male or female patients age 18 years or older (For India only, male or female patients age \>=18 years and \<=75 years)
• adequate organ function, defined as all of the following:
• Absolute Neutrophil Count (ANC) \> 1500/mm3. (ANC \>1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
• Platelet count \>75,000/mm3
• Serum creatinine \< 1.5 times of the upper limit of normal
• Total Bilirubin \< 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be \<4 times institutional upper limit of normal).
• Aspartate Amino Transferase (AST) and Alanine Amino Transferase (ALT) \< three times the upper limit of (institutional) normal (ULN) (if related to liver metastases \< five times ULN). 5) Eastern Cooperative Oncology Group (ECOG) score between 0 - 2 6) written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.

You may not qualify if:

• prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
• use of anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and / or gonadorelin analogues for treatment of prostate cancer permitted)
• radiotherapy within 4 weeks prior to drug administration except as follows:
• palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
• single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
• major surgery within 4 weeks from day 1 of first dose of afatinib. At least 7 days should have elapsed since minor surgical procedure including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS).
• known hypersensitivity to afatinib or any of its excipients
• 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 starting trial treatment.
• Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use medically acceptable method of contraception during the trial entry and for at least 4 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential. Perimenopausal women must be amenorrhoeic for at least 24 months to be considered for non-childbearing potential.
• childbearing potential (see Section 4.2.3) who:
• are nursing or
• are pregnant or
• are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
• history of or co-existing condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
• previous or concomitant malignancies at other sites, except effectively treated nonmelanoma 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (33)

307 Hospital of PLA

Beijing, 100071, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

Jilin Province Cancer Hospital

Changchun, China

Location

Guangdong Provincial People's Hospital

Guangzhou, 510080, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Lin Yi Tumor Hospital

Linyi, 276002, China

Location

Jiangsu Cancer Hospital

Nanjing, 210000, China

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Vikram Hospital

Bangalore, 560052, India

Location

HCG Hospital

Bengaluru, 560027, India

Location

P VS Hospital Pvt Ltd

Calicut, 673002, India

Location

V S Hospital

Chennai, 600031, India

Location

Max Super Speciality Hospital, Delhi

Delhi, 110092, India

Location

Global Hospitals

Hyderabad, 500004, India

Location

Basavatarakam Indo - American Cancer Hospital & Research Ins

Hyderabad, 500034, India

Location

SEAROC Cancer Centre

Jaipur, 302004, India

Location

B. P. Poddar Hospital & Medial Research Ltd

Kolkata,West Bengal, 700053, India

Location

Asirvatham Multispeciality Hospital

Madurai, 625 020, India

Location

Curie Manavata Cancer Centre

Maharashtra, 422 004, India

Location

Shatabdi Superspeciality Hospital

Maharashtra, 422005, India

Location

Prince Aly Khan Hospital

Mumbai, 400010, India

Location

Ruby Hall Clinic

Pune, 411001, India

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

E-Da Hospital

Kaohsiung City, 824, Taiwan

Location

NCKUH

Tainan, 704, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Chang-Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

Location

Related Publications (2)

• Zhao J, Bai H, Wang X, Wang Y, Duan J, Chen H, Xue Z, Tian Y, Cseh A, Huang DC, Wu YL, Wang J. Biomarker subset analysis of a phase IIIb, open-label study of afatinib in EGFR tyrosine kinase inhibitor-naive patients with EGFRm+ non-small-cell lung cancer. Future Oncol. 2022 Apr;18(12):1485-1497. doi: 10.2217/fon-2021-0394. Epub 2022 Feb 4.

  PMID: 35114807 DERIVED

• Tu HY, Feng J, Shi M, Zhao J, Wang Y, Chang J, Wang J, Cheng Y, Zhu J, Tan EH, Li K, Zhang Y, Lee V, Yang CT, Su WC, Lam DC, Srinivasa BJ, Rajappa S, Ho CL, Lam KC, Hu Y, Bondarde SA, Liu X, Tian Y, Xue Z, Cseh A, Huang DC, Zhou C, Wu YL. A Phase IIIb Open-Label, Single-Arm Study of Afatinib in EGFR TKI-Naive Patients with EGFRm+ NSCLC: Final Analysis, with a Focus on Patients Enrolled at Sites in China. Target Oncol. 2022 Jan;17(1):1-13. doi: 10.1007/s11523-021-00859-6. Epub 2022 Jan 12.

  PMID: 35020119 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

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

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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 1, 2013
• Study Start: September 30, 2013
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-06

Locations

IN (14); SG (1); TW (4); CN (12); HK (2)