Lung Squamous Cell CarcinomaPhase 4NCT04132102
To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation
A Phase 4 study testing Afatinib in people with Lung Squamous Cell Carcinoma, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is an open-label, sing-arm, single site, phase IV clinical study. The main objective is to evaluate the efficacy of afatinib in LSQC patients with EGFR sensitive mutation, and to explore the clinical factors which might be predictive for the effectiveness in LSQC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Squamous Cell Carcinoma
- What is being tested?
- Afatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2018to 31 Aug 2021
- 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
- Selected patients must meet all of the following standards:
- The patient's or his/her legal representative's has signed and dated written informed consent before any specific study procedure.
- The patient is above 18 years old.
- Locally advanced (IIIB) or metastatic (stage IV) immunohistochemistry (IHC)-verified Lung squamous cell carcinoma (LSQC) with EGFR sensitive mutation patients, whom previously untreated or received platinum-based doublet chemotherapy as first-line treatment with subsequent disease progression, and had to be eligible for second-line treatment.
- The patient has NOT previously received EGFR-TKI treatment.
- ECOG Performance Status Score is 0~2.
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- The patient has sufficient bone marrow and organ function proved by baseline complete plasma count, plasma biochemistry and urinary biochemistry tests.
- Female patients of childbearing age must use adequate contraceptives, and breastfeeding is not allowed.
- Male patients must voluntarily to use contraceptives.
Who cannot join
- Selected patients can not meet any one of the following standards:
- The patient has received EGFR-TKI treatment.
- The patient has any severe or uncontrolled systemic signs of illness, including uncontrolled hypertension, active easy-bleeding constitution, active infection, or significantly impaired function of bone marrow or organs, which researchers believe can significantly change the patient's risk/benefit balance.
- The patient has symptomatic central nervous system (CNS) metastases.
- The patient has the history of interstitial pneumonia, or radiation pneumonia which needs steroid treatment.
- The patient still has unrecovered toxic reaction with ≥ grade 3 (CTCAE5.0) caused by previously received treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Yongfeng Yu, Master
About this study
Official title: An Open-label, Single-arm Clinical Study to Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation
This is an open-label, sing-arm, single site, phase IV clinical study. The main objective is to evaluate the efficacy of afatinib in LSQC patients with EGFR sensitive mutation, and to explore the clinical factors which might be predictive for the effectiveness in LSQC.
Read the detailed description
This is an open-label, sing-arm phase IV clinical study which will recruit about 20 patients in China.
The main objective of this study is to evaluate the efficacy of afatinib in LSQC patients with EGFR sensitive mutation, and to explore the clinical factors which might be predictive for the effectiveness in LSQC.
Target patient population:Locally advanced (IIIB) or metastatic (stage IV) immunohistochemistry (IHC)-verified Lung squamous cell carcinoma (LSQC) with EGFR sensitive mutation patients, whom previously untreated or received platinum-based doublet chemotherapy as first-line treatment with subsequent disease progression, and had to be eligible for second-line treatment.
Investigational product, the dose and administration method: Afatinib is a member of the second generation TKIs, which binds irreversibly to the erbB family of receptors. Afatinib will be administrated orally with the starting dose of 40 mg tablets, once per day. If patients can't tolerate drug related AEs with 40mg, patients can receive 30mg once per day after AEs recovered to Grade 0-1 (CTCAE 5.0).
Study assessment: The collected data include the patient's demographic characteristics, information needed to determine whether the patient is eligible (including medical history, attributes of previous and current disease, and EGFR mutation status in tumor tissues), efficacy of objective response rate(ORR), progression-free survival (PFS), overall survival (OS), and safety (including serious adverse events and dose change-induced adverse events).
- Conditions
- Lung Squamous Cell Carcinoma
- Being tested
- Afatinib
- Keywords
- LSQC, EGFR mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
Also called GIOTRIF®
Afatinib is a member of the second generation TKIs, which binds irreversibly to the erbB family of receptors. Afatinib will be administrated orally with the starting dose of 40 mg tablets, once per day. If patients can't tolerate drug related AEs with 40mg, patients can receive 30mg once per day after AEs recovered to Grade 0-1.
| Study group | Role | What they receive |
|---|---|---|
| Afatinib treatment group | Experimental | This is an open-label, sing-arm phase IV clinical study Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS refers to the time from initial prescription of afatinib to the time of disease progression or death recorded in CRF in this study, no matter whether the patient withdraw from the treatment before disease progression or receive other anti-cancer treatment or not. For the patient without progression or death at the time of analysis, the latest assessment date will be used as interpolation (censoring). (Or, if there's no tumor assessment after baseline visit, baseline visit date will be used
Measured: Up to 12 months
Secondary outcomes (3)
Objective response rate (ORR)
ORR refers to the incidence of complete remission (CR) or partial remission (PR) (determined according to RECIST1.1 standards)
Measured: Up to 12 months
Overall survival (OS)
OS refers to the time from the patient entering into the group to the time of death. When it comes to the analysis of patients with unknown survival status, the last date when learning of the patient's survival will be used as interpolation (censoring)
Measured: Up to 12 months
Rate of SAEs, dose change-induced AEs, and AEs of particular concerns.
Serious adverse events [SAEs], dose change-induced AEs, and AEs of particular concerns.
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 posted18 Oct 2019
- Study start27 Nov 2018
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Squamous Cell CarcinomaStudies 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
- 20 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
- NCT04132102
- Sponsor's protocol ID
- XK-LS-001
- Status last verified
- Oct 2019
- First submitted
- 27 Nov 2018
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Clinical Study to Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation
- ClinicalTrials.gov ID
- NCT04132102
- Acronym / sponsor ID
- XK-LS-001
- Conditions
- Lung Squamous Cell Carcinoma
- Keywords
- LSQC, EGFR mutation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 18 Oct 2019 (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, single site, phase IV clinical study. The main objective is to evaluate the efficacy of afatinib in LSQC patients with EGFR sensitive mutation, and to explore the clinical factors which might be predictive for the effectiveness in LSQC.
Detailed description
This is an open-label, sing-arm phase IV clinical study which will recruit about 20 patients in China.
The main objective of this study is to evaluate the efficacy of afatinib in LSQC patients with EGFR sensitive mutation, and to explore the clinical factors which might be predictive for the effectiveness in LSQC.
Target patient population:Locally advanced (IIIB) or metastatic (stage IV) immunohistochemistry (IHC)-verified Lung squamous cell carcinoma (LSQC) with EGFR sensitive mutation patients, whom previously untreated or received platinum-based doublet chemotherapy as first-line treatment with subsequent disease progression, and had to be eligible for second-line treatment.
Investigational product, the dose and administration method: Afatinib is a member of the second generation TKIs, which binds irreversibly to the erbB family of receptors. Afatinib will be administrated orally with the starting dose of 40 mg tablets, once per day. If patients can't tolerate drug related AEs with 40mg, patients can receive 30mg once per day after AEs recovered to Grade 0-1 (CTCAE 5.0).
Study assessment: The collected data include the patient's demographic characteristics, information needed to determine whether the patient is eligible (including medical history, attributes of previous and current disease, and EGFR mutation status in tumor tissues), efficacy of objective response rate(ORR), progression-free survival (PFS), overall survival (OS), and safety (including serious adverse events and dose change-induced adverse events).
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: AfatinibThis 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)
- Selected patients must meet all of the following standards:
Key exclusion criteria (6 listed)
- Selected patients can not meet any one of the following standards:
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 |
|---|---|---|
| AfatinibAlso: GIOTRIF®Afatinib is a member of the second generation TKIs, which binds irreversibly to the erbB family of receptors. Afatinib will be administrated orally with the starting dose of 40 mg tablets, once per day. If patients can't tolerate drug related AEs with 40mg, patients can receive 30mg once per day after AEs recovered to Grade 0-1. | Drug | Afatinib treatment group |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 12 months
PFS refers to the time from initial prescription of afatinib to the time of disease progression or death recorded in CRF in this study, no matter whether the patient withdraw from the treatment before disease progression or receive other anti-cancer treatment or not. For the patient without progression or death at the time of analysis, the latest assessment date will be used as interpolation (censoring). (Or, if there's no tumor assessment after baseline visit, baseline visit date will be used
3 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 12 months
Overall survival (OS)
Time frame: Up to 12 months
Rate of SAEs, dose change-induced AEs, and AEs of particular concerns.
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 29 Oct 2019.
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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.
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 in people with Lung Squamous Cell Carcinoma, 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 6 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 29 Oct 2019. 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?
Progression-free survival (PFS) (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 29 Oct 2019.