Carcinoma, Non-Small-Cell LungPhase 3NCT01953913
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
A Phase 3 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 33 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Afatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 33 sitesin 5 countries
- Study dates
- 30 Sep 2013to 6 Jul 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
- requiring treatment with any of the prohibited concomitant medications listed, that cannot be stopped for the duration of trial participation
- known pre-existing interstitial lung disease
- presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment.
- Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
- meningeal carcinomatosis
- symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication)
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
India14 sites
Vikram Hospital
Bangalore, 560052
HCG Hospital
Bengaluru, 560027
P VS Hospital Pvt Ltd
Calicut, 673002
V S Hospital
Chennai, 600031
Max Super Speciality Hospital, Delhi
Delhi, 110092
Global Hospitals
Hyderabad, 500004
Basavatarakam Indo - American Cancer Hospital & Research Ins
Hyderabad, 500034
SEAROC Cancer Centre
Jaipur, 302004
B. P. Poddar Hospital & Medial Research Ltd
Kolkata,West Bengal, 700053
Asirvatham Multispeciality Hospital
Madurai, 625 020
Curie Manavata Cancer Centre
Maharashtra, 422 004
Shatabdi Superspeciality Hospital
Maharashtra, 422005
Prince Aly Khan Hospital
Mumbai, 400010
Ruby Hall Clinic
Pune, 411001
China12 sites
307 Hospital of PLA
Beijing, 100071
Beijing Cancer Hospital
Beijing, 100142
Chinese PLA General Hospital
Beijing, 100853
Jilin Province Cancer Hospital
Changchun
Guangdong Provincial People's Hospital
Guangzhou, 510080
Zhejiang Cancer Hospital
Hangzhou, 310022
Lin Yi Tumor Hospital
Linyi, 276002
Jiangsu Cancer Hospital
Nanjing, 210000
Shanghai Chest Hospital
Shanghai, 200030
Fudan University Shanghai Cancer Center
Shanghai, 200032
Shanghai Pulmonary Hospital
Shanghai, 200433
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Taiwan4 sites
E-Da Hospital
Kaohsiung City, 824
NCKUH
Tainan, 704
Tri-Service General Hospital
Taipei, 11490
Chang-Gung Memorial Hospital, Linkou
Taoyuan County, 333
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin
About this study
Official title: An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
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
- Being tested
- Afatinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
Patient will receive afatinib once daily
| Study group | Role | What they receive |
|---|---|---|
| Afatinib | Experimental | Patient will receive afatinib once daily Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of participants with serious adverse events (SAEs).
Measured: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Secondary outcomes (2)
Time to Symptomatic Progression (TTSP)
Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment. 95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.
Measured: 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
Percentage of participants with drug-related (afatinib-related) adverse events.
Measured: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study start30 Sep 2013
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953913
- Sponsor's protocol ID
- 1200.66
- Status last verified
- Jun 2019
- First submitted
- 25 Sep 2013
- Last updated
- 12 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 35114807Tu 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.
PubMed 35020119
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
- ClinicalTrials.gov ID
- NCT01953913
- Acronym / sponsor ID
- 1200.66
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Posted 12 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib | Experimental | Drug: AfatinibPatient will receive afatinib once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (21 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfatinibPatient will receive afatinib once daily | Drug | Afatinib |
Primary outcome
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Percentage of participants with serious adverse events (SAEs).
2 secondary outcomes
Time to Symptomatic Progression (TTSP)
Time frame: 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
Time frame: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35114807Zhao 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.
- Derived from this study: PubMed 35020119Tu 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
33 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 33 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in India, China, Taiwan, Hong Kong, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Serious Adverse Events (SAEs) (time frame: From first drug administration up to 28 days after last drug administration, up to 1624 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01953913, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.