NRG1-fused Non-small Cell Lung CancerPhase 4NCT04814056
To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion
A Phase 4 study testing Afatinib Dimaleate in people with NRG1-fused Non-small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is an open-label, sing-arm, phase IV clinical study. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NRG1-fused Non-small Cell Lung Cancer
- What is being tested?
- Afatinib Dimaleate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- The patient or his/her legal representative has signed a written informed consent form and dated it prior to any specific research procedure.
- Aged 18 years or older.
- Locally advanced or metastatic non-small cell lung cancer with NRG1 fusion detected by DNA or RNA-based next-generation sequencing (NGS) technology in tumor tissue specimens or liquid specimens.
- The patient has received platinum-based doublet chemotherapy previously.
- ECOG performance status score is 0~2.
- The patient has sufficient bone marrow and organ functionality, which can be proved by complete blood cell count, blood biochemistry and urine biochemistry tests at baseline.
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- The patient has measurable lesion(s).
- The female patient of childbearing age must adopt appropriate contraceptive measures and are not allowed to breastfeed a child.
- The male patient must voluntarily use contraceptives.
Who cannot join
- The patient has shown any severe or uncontrollable systemic disease sign that the investigators believe may significantly change the risk/benefit balance of the patient, including uncontrollable hypertension, high active bleeding tendency, active infection or significant damage of bone marrow or other functions.
- The patient has previously been treated with EGFR-TKI or any monoclonal antibody that acts on HER2/3.
- The patient has been found with symptomatic metastatic tumor of central nervous system (CNS).
- The patient has a history of interstitial pneumonia or radiation pneumonia requiring steroid therapy.
- The patient has not recovered yet from toxic reactions with CTCAE grade ≥3 (CTCAE5.0) caused by previous treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Yongfeng Yu, Master, 18017321559
About this study
Official title: An Open-Labeled, Single-Arm Clinical Study to Evaluate the Efficacy of Afatinib in Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer With NRG1-Fusion
This is an open-label, sing-arm, phase IV clinical study. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment.
Read the detailed description
This is an open-label, sing-arm clinical study,which will recruit about 15 patients in China.
The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment.
Target Patient Population:Locally advanced (stage IIIB) or metastatic (stage IV) NRG1-fused non-small cell lung cancer patients, who have previously received platinum-based doublet chemotherapy and developed disease progression subsequently.
Test Drug, Dosage and Medication Regimen:Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D.
Evaluations of Study:The data to be collected include demographic characteristics of the patients, information necessary to determine whether the patients are qualified (including medical history, features of previous and current diseases and NRG1 fusion status in tumor tissue), and efficacy and safety data in terms of objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).
- Conditions
- NRG1-fused Non-small Cell Lung Cancer
- Being tested
- Afatinib Dimaleate
- Keywords
- Locally advanced (stage IIIB) or metastatic (stage IV), have previously received platinum-based doublet chemotherapy and developed disease progression subsequently
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afatinib DimaleateDrug
Also called GIOTRIF®
Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D.
| Study group | Role | What they receive |
|---|---|---|
| Afatinib treatment group | Experimental | This is an open-label, sing-arm phase IV clinical study Receives: Drug: Afatinib Dimaleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
ORR
Measured: Up to 12 months
Secondary outcomes (2)
disease control rate (DCR)
DCR
Measured: Up to 12 months
progression-free survival (PFS)
PFS
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jun 2021 (estimated)
- Primary completion29 Sep 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NRG1-fused Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Shun, Shanghai Chest Hospital
- Investigators
- Yongfeng Yu, Master, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814056
- Sponsor's protocol ID
- BI-IIT-AFATINIB-I
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled, Single-Arm Clinical Study to Evaluate the Efficacy of Afatinib in Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer With NRG1-Fusion
- ClinicalTrials.gov ID
- NCT04814056
- Acronym / sponsor ID
- BI-IIT-AFATINIB-I
- Conditions
- NRG1-fused Non-small Cell Lung Cancer
- Keywords
- Locally advanced (stage IIIB) or metastatic (stage IV), have previously received platinum-based doublet chemotherapy and developed disease progression subsequently
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 29 Sep 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, sing-arm, phase IV clinical study. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment.
Detailed description
This is an open-label, sing-arm clinical study,which will recruit about 15 patients in China.
The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment.
Target Patient Population:Locally advanced (stage IIIB) or metastatic (stage IV) NRG1-fused non-small cell lung cancer patients, who have previously received platinum-based doublet chemotherapy and developed disease progression subsequently.
Test Drug, Dosage and Medication Regimen:Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D.
Evaluations of Study:The data to be collected include demographic characteristics of the patients, information necessary to determine whether the patients are qualified (including medical history, features of previous and current diseases and NRG1 fusion status in tumor tissue), and efficacy and safety data in terms of objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib treatment group | Experimental | Drug: Afatinib DimaleateThis is an open-label, sing-arm phase IV clinical study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient or his/her legal representative has signed a written informed consent form and dated it prior to any specific research procedure.
- Aged 18 years or older.
- Locally advanced or metastatic non-small cell lung cancer with NRG1 fusion detected by DNA or RNA-based next-generation sequencing (NGS) technology in tumor tissue specimens or liquid specimens.
- The patient has received platinum-based doublet chemotherapy previously.
- ECOG performance status score is 0~2.
Key exclusion criteria (5 listed)
- The patient has shown any severe or uncontrollable systemic disease sign that the investigators believe may significantly change the risk/benefit balance of the patient, including uncontrollable hypertension, high active bleeding tendency, active infection or significant damage of bone marrow or other functions.
- The patient has previously been treated with EGFR-TKI or any monoclonal antibody that acts on HER2/3.
- The patient has been found with symptomatic metastatic tumor of central nervous system (CNS).
- The patient has a history of interstitial pneumonia or radiation pneumonia requiring steroid therapy.
- The patient has not recovered yet from toxic reactions with CTCAE grade ≥3 (CTCAE5.0) caused by previous treatment.
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 DimaleateAlso: GIOTRIF®Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D. | Drug | Afatinib treatment group |
Primary outcome
objective response rate (ORR)
Time frame: Up to 12 months
ORR
2 secondary outcomes
disease control rate (DCR)
Time frame: Up to 12 months
progression-free survival (PFS)
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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.
Yongfeng Yu, Master study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Afatinib Dimaleate in people with NRG1-fused Non-small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongfeng Yu, Master (18017321559, yuyongfeng212@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: Up to 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 1 Apr 2021.