Lung CancerPhase 2NCT00616499
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
A Phase 2 study testing gefitinib, neoadjuvant therapy and therapeutic conventional surgery in people with Lung Cancer, run by Yonsei University at 4 sites in South Korea.
Trial summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- gefitinib, neoadjuvant therapy and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2006to Nov 2010
- Phase
- Phase 2
- 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
- ECOG performance status 0-1
- FEV_1 ≥ 2.0 L in preoperative pulmonary function test
- Hemoglobin ≥ 9.0 g/dL
- WBC 4,000-12,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/mm³
Show all 11Show fewer
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3.0 times ULN
- AST and ALT ≤ 3.0 times ULN
- Creatinine ≤ 1.5 times ULN
- Negative pregnancy test
Who cannot join
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy, chemotherapy, hormone therapy, or target therapy
- No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Contact Person, 82-2-2072-1742
- Recruiting
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, 120-752
Joo-Hang Kim, MD, 82-2-2228-8131, kjhang@yuhs.ac
- Recruiting
Samsung Medical Center
Seoul, 135-710
Contact Person, 82-2-3410-1247
- Recruiting
Asan Medical Center - University of Ulsan College of Medicine
Seoul, 138-736
Contact Person, 82-2-3010-7282
About this study
Official title: A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (EGFR) mutations.
Secondary
- To determine the complete resection rate in patients treated with this drug.
- To determine the overall survival rate in patients treated with this drug.
- To determine the disease-free survival rate in patients treated with this drug.
- To determine the pathologic complete response rate in patients treated with this drug.
- To determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients with resectable disease may undergo surgery. Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy.
After completion of study therapy, patients are followed for 2 years.
- Conditions
- Lung Cancer
- Being tested
- gefitinib, neoadjuvant therapy, therapeutic conventional surgery
- Keywords
- stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
neoadjuvant therapyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (5)
Complete resection rate
Overall survival rate
Median disease-free survival
Complete pathological response rate
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Joo-Hang Kim, MD, Study chair, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616499
- Sponsor's protocol ID
- CDR0000582623
- Other IDs
- YONSEI-4-2006-0136, ZENECA-YONSEI-4-2006-0136
- Status last verified
- Sep 2008
- First submitted
- 14 Feb 2008
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00616499
- Acronym / sponsor ID
- CDR0000582623
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2010 (estimated)
- First posted
- 15 Feb 2008 (estimated)
- 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.
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (EGFR) mutations.
Secondary
- To determine the complete resection rate in patients treated with this drug.
- To determine the overall survival rate in patients treated with this drug.
- To determine the disease-free survival rate in patients treated with this drug.
- To determine the pathologic complete response rate in patients treated with this drug.
- To determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients with resectable disease may undergo surgery. Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy.
After completion of study therapy, patients are followed for 2 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ECOG performance status 0-1
- FEV_1 ≥ 2.0 L in preoperative pulmonary function test
- Hemoglobin ≥ 9.0 g/dL
- WBC 4,000-12,000/μL
- ANC ≥ 1,500/μL
Key exclusion criteria (8 listed)
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
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 |
|---|---|---|
| gefitinib | Drug | – |
| neoadjuvant therapy | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
Primary outcome
Response rate
5 secondary outcomes
Complete resection rate
Overall survival rate
Median disease-free survival
Complete pathological response rate
Toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea
Joo-Hang Kim, MD study chair
Yonsei University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gefitinib, neoadjuvant therapy and therapeutic conventional surgery in people with Lung Cancer, run by Yonsei University at 4 sites in South Korea.
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 8 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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. 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 9 Feb 2009.