- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201756
Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma
Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma: A Single-Arm, Open-Label, Phase II Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shang'ai, Shanghai, China, 200433
- Shanghai pulmonary hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lung adenocarcinoma patient with EGFR sensitive mutation as confirmed by needle biopsy;
- At stage III (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
- No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
- With the feasiblility or potential feasibility to receive radical surgery (radical lung lobectomy+systematic lymph node dissection);
- Good lung function that could tolerate surgical treatment;
- Aged >= 18 years;
- At least one measurable tumor foci (the longest diameter measured by CT shall be > 10 mm);
- Other major organs shall function well (liver, kidney, blood system, etc.):
- ECOG PS score shall be 0-1;
- The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
- The patient shall sign the Informed Consent Form.
Exclusion Criteria:
- The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
- The patient suffered from other cancers besides NSCLC (except cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor [including Ta and Tis]) within 5 years before the trial;
- The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure [≥ Grade II specified by New York Heart Association (NYHA)], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
- The patient is a carrier of active hepatitis B, hepatitis C or HIV;
- The patient suffers from severe or new-onset gastrointestinal diseases with diarrhea as the main symptom;
- The patient is receiving the P glycoprotein inhibitor therapy;
- The patient has had or is currently suffering from cardiovascular malformation;
- The patient has had or is currently suffering from interstitial lung disease;
- The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
- The patient is allergic to afatinib or its any excipients;
- The patient suffers from nervous system diseases or mental diseases and cannot keep compliance with the trial;
- The patient has any malabsorption condition;
- The female patient is in pregnancy or lactation period;
- There are any conditions under which the investigator considers the patient is not suitable to be enrolled.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Afatinib
|
①Neoadjuvant treatment stage: the enrolled patients take afatinib at a dosage of 40mg per day, 8-16 weeks in total; and receive CT scan re-examination in the 4th/8th/12th post-therapy week. ②Surgical treatment stage: the patients who respond to alfatinib treatment (CR+PR) and the patients who do not respond to alfatinib therapy but could still undergo surgery (SD and PD) will receive radical lung lobectomy+systematic lymph node dissection. ③Adjuvant treatment stage: The CR, PR and SD patients who have been treated surgically will take alfatinib at a dosage of 40mg per day for at least 1 year. The SD and PD patients who could not receive operation and the PD patients who have received operation will be transferred into medical oncology or/and radiation oncology and receive comprehensive therapy (chemotherapy or/and radiotherapy, the regimen is designed by oncologist and radiologist) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 11 weeks
|
ORR is defined as the proportion of patients who have completed the 8- to 16-week treatment with afatinib before operation and have achieved CR or PR as confirmed by CT evaluation after 3 weeks in all patients.
|
11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 resection
Time Frame: 9 weeks
|
It is defined as the proportion of patients with negative surgical margin and no residual found under microscope after resection in all patients who have completed the treatment.
|
9 weeks
|
Pathological downstaging rate
Time Frame: 11 weeks
|
It is defined as the proportion of patients who have completed the 8-week treatment with afatinib before operation and have achieved a T stage downing of the tumor as confirmed by CT evaluation after 3 weeks in all patients who have completed the treatment.
|
11 weeks
|
Treatment-related adverse events
Time Frame: 12 weeks
|
It refers to the number of adverse events related to afatinib monotherapy or platinum-based chemotherapy as evaluated according to CTCAE v4.0.
|
12 weeks
|
Health related quality of life (HRQol)
Time Frame: 12 weeks
|
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 & LC13, Version 3).
EORTC's QLQ-C30 & LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items.
Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options.
The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively.
The higher score, the worse quality.
|
12 weeks
|
Event-free survival (EFS)
Time Frame: up to 60 months
|
It is was defined as the time from the first administration of afatinib in this study to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause (including any cause of death in the event of no progression)
|
up to 60 months
|
Disease free survival (DFS)
Time Frame: up to 100 months
|
It refers to the time from radical surgery to relapse or death of a participant due to disease progression.
|
up to 100 months
|
Overall survival (OS)
Time Frame: up to 60 months
|
It is defined as the time from random enrollment to death of participant due to any cause.
|
up to 60 months
|
Progression-free survival (PFS)
Time Frame: up to 60 months
|
It is defined as the time from the first administration of afatinib in this study to the disease progression or death.
|
up to 60 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenocarcinoma
- Adenocarcinoma of Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Afatinib
Other Study ID Numbers
- 1200.0328(TEAM, LungMate-004)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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