Carcinoma, Non-Small-Cell LungPhase 2NCT02597946
Afatinib in NSCLC With HER2 Mutation
A Phase 2 study testing afatinib and paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 9 sites in 2 countries.
Trial summary
to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2 mutations, previously treated with 1 or 2 chemotherapy regimens 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 and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 18 Mar 2016to 22 Jul 2018
- Phase
- Phase 2
- 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
- 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
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- Recovered from any previous therapy related toxicity to <=Grade 1 at study entry (except for stable sensory neuropathy <=Grade 2 and alopecia)
- Written informed consents that is consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) and local GCP guidelines Inclusion criterion for Part B
- Adequate organ function, as inclusion criteria No.6
- ECOG performance score 0~2
- More than 12 weeks clinical benefit (PR, Complete Response (CR), SD) in part A Further inclusion criteria apply
Who cannot join
- 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.
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- 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.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial Exclusion criterion for Part B Any known contraindication for paclitaxel treatment. Not able to tolerate lowest dose of afatinib. Peripheral polyneuropathy >Grade 2 Further exclusion criteria apply
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
China8 sites
Hunan Province Tumor Hospital
Changsha, 410013
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
Zhejiang Cancer Hospital
Hangzhou, 310022
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
First Hospital Affiliated with Nanjing Medical University
Nanjing, 210029
Zhongshan Hospital Fudan University
Shanghai, 200032
Shanghai Pulmonary Hospital
Shanghai, 200433
Henan Cancer Hospital
Zhengzhou, 450008
About this study
Official title: A Phase II Study of Afatinib in Patients With Advanced NSCLC Harboring HER2 Mutations, Previously Treated With Chemotherapy
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
- Being tested
- afatinib, paclitaxel
- 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
paclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| all patients | Experimental | Part A: all enrolled patients will receive afatinib monotherapy. Part B: all eligible patients will receive afatinib combined with weekly paclitaxel. Receives: Drug: afatinib; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Percentage of patients with disease control (DC) in part A. Disease control defined as patients who have achieved confirmed complete response, partial response and stable disease as measured by CT scan or MRI according to RECIST 1.1 in part A.
Tumour Response is based on clinical, radiological or other assessment. Clopper-Pearson method used for confidence limits.
Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, taking as reference the baseline sum LD, nor sufficient increase to qualify for Progression (PD) taking as reference the smallest sum LD since the treatment started.
Measured: 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
Progression Free Survival (PFS) defined as the time from the date of starting treatment of afatinib to the date of disease progression per RECIST 1.1, or to the date of death no matter which happens first in part A.
Median and 95% confidence interval (CI) are calculated from an unadjusted Kaplan-Meier curve.
Measured: 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)
Overall survival (OS) defined as the time from start of treatment of afatinib until death from any cause.
Median and 95% CI are calculated from an unadjusted Kaplan-Meier curve.
Measured: From start of treatment of afatinib until death from any cause, ie up to approximately 12 Months
Time to Progression (TTP) in Part A
Time to progression (TTP) defined as the time from the date of starting treatment of afatinib to the date of disease progression per RECIST 1.1 in part A.
Median and 95% CI are calculated from an unadjusted Kaplan-Meier curve.
Measured: 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
Duration of response (DoR) defined as the time from the first documented response PR or CR to the date of tumor progression evaluated according to RECIST 1.1 or death in part A.
Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions.
No patient had objective response and DoR was not analysed.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start18 Mar 2016
- Primary completion22 Jul 2018
- Study completion22 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT02597946
- Sponsor's protocol ID
- 1200.222
- Status last verified
- Jan 2025
- First submitted
- 2 Nov 2015
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Afatinib in Patients With Advanced NSCLC Harboring HER2 Mutations, Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT02597946
- Acronym / sponsor ID
- 1200.222
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2016 (actual)
- Primary completion
- 22 Jul 2018 (actual)
- Study completion
- 22 Jul 2018 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2 mutations, previously treated with 1 or 2 chemotherapy regimens
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | Experimental | Drug: afatinib, Drug: paclitaxelPart A: all enrolled patients will receive afatinib monotherapy. Part B: all eligible patients will receive afatinib combined with weekly paclitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| afatinib | Drug | all patients |
| paclitaxel | Drug | all patients |
Primary outcome
Percentage of Patients With Objective Response (OR) in Part A According to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
Time frame: 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
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.
5 secondary outcomes
Percentage of Patients With Disease Control (DC) in Part A
Time frame: 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
Time frame: 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)
Time frame: From start of treatment of afatinib until death from any cause, ie up to approximately 12 Months
Time to Progression (TTP) in Part A
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing afatinib and paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 9 sites in 2 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 11 inclusion and 16 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China, Malaysia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Oct 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 Patients With Objective Response (OR) in Part A According to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2025.