2-year Disease-Free SurvivalPhase 3NCT03203590
Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients
A Phase 3 study testing Oral Navelbine + Carboplatin and Gefitinib in people with 2-year Disease-Free Survival, run by Sun Yat-sen University at 5 sites in China.
Trial summary
The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- 2-year Disease-Free Survival
- What is being tested?
- Oral Navelbine + Carboplatin and Gefitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 5 sitesChina
- Study dates
- Sep 2017to Jan 2026
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis of non small cell lung cancer, Stage Ⅱ-ⅢA before treatment
- EGFR Gene mutated
- ECOG 0-1
- liver, kidney and bone marrow are functional healthy，WBC>4.0×109/L，PLT>100×109/L Hb>10g/dL;Cr<1.8mg/dL，bilirubin<1.5mg/dL，GPT<1.5 upper limit of normal
- No vital systems dysfunction or malnutrition
- No other malignant diseases in 5 years（except non melanoma or Cervical carcinoma in situ）
- Have never accepted radiation therapy、overall chemotherapy or biotherapy
- Know the whole protocol，Voluntary participate and sign a consent form
Who cannot join
- Tumor has violated the surrounding tissue organs（T4）
- Preoperative have evidence of distant metastasis including the contralateral mediastinal lymph nodes
- Arrhythmia need anti-arrhythmic treatment（except for β-blockers or digoxin），Symptomatic coronary artery disease and myocardial ischemia (myocardial infarction) in the past 6 months or more than NYHA class II congestive heart failure
- Adverse drug control severe hypertension
- Moderate to severe proteinuria
- History of HIV infection or activity of chronic hepatitis b or hepatitis c, or other active clinical severe infection
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- Cachexy,organ function decompensation
- History of chest radiotherapy
- Not fully control the eye inflammation
- Epilepsy patients needed treatment（such as Steroids or antiepileptic cure）
- Interstitial pneumonia
- Drug abuse and medical, psychological or social conditions may interfere with the patients involved in the research or have an impact on the results of evaluation
- Known or suspected to study drug allergy or to give any drug allergies associated with this test
- Any unstable situation or may endanger the patient safety and compliance
- Fertility and pregnancy or lactation women, and have not been sufficient precautions
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Dongguan People's Hospital
Dongguan, Guangdong, 523000
Jianping Zhou, MD
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Guowei Ma, MD, magw@sysucc.org.cn
Guowei Ma
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Jinming Zhao, MD
Maoming Affiliated Hospital of Southern Medical University
Maoming, Guangdong, 525000
Jiang Huang, MD
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000
Guangsuo Wang, MD
About this study
Official title: Oral Navelbine Carboplatin Versus Gefitinib Neoadjuvant Therapy for Resectable EGFR Mutation Positive Stage Ⅱ-ⅢA NSCLC, Prospective, Randomized, Multicenter, Phase Ⅲ Clinical Trial
The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation.
Read the detailed description
Lung cancer is the most common cause of cancer mortality in men and women in the world. LACE meta analysis shows that the 5-year survival rate of post-operation chemotherapy group rose by 5.4%, therefore, adjuvant chemotherapy has been the main treatment after surgery according to National Comprehensive Cancer Network (NCCN) Guideline. But patients have poor compliance due to physical condition after surgery. Compared with adjuvant chemotherapy, neoadjuvant therapy has better patient compliance and tolerance.Targeted therapy, with milder side effect compared with chemotherapy, may be a promising choice to treat NSCLC previously. But to date, there is no enough evidence to support the efficacy and safety of neoadjuvant targeted therapy in patients with EGFR mutation.The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy vs Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable NSCLC patients harboring EGFR mutation.
- Conditions
- 2-year Disease-Free Survival
- Being tested
- Oral Navelbine + Carboplatin, Gefitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Navelbine + CarboplatinDrug
Also called Vinorelbine, Carboplat
The patient will be given Navelbine 60 mg/m2, p.o. day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v. day 1 of every cycle.After 2 cycle we will evaluate their clinical response.Then operable patients will have surgery.
GefitinibDrug
Also called Iressa
The patient will be given Gefitinib 250mg,p.o.,q.d. for 8 weeks.After 8 weeks we evaluate their clinical response.Then operable patients will have surgery.
| Study group | Role | What they receive |
|---|---|---|
| Oral Navelbine + Carboplatin | Active comparator | Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with Navelbine + Carboplatin. Receives: Drug: Oral Navelbine + Carboplatin |
| Gefitinib | Experimental | Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with gefitinib. Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year disease free survival
Measured: 2 years
Secondary outcomes (10)
Objective response rate
Measured: 1 week before surgery
Pathologic complete response
Measured: Within 1 month after surgery
Side effects
Measured: 1 week before surgery
Standard uptake value
Measured: 1 week before surgery
Tumor reduction rate
Measured: Within 1 month after surgery
Mediastinal lymph nodes clearance
Measured: Within 1 month after surgery
Postoperative complications
Measured: Within 1 month after discharge
R0 resection rate
Measured: Within 1 month after surgery
Postoperative mortality rate
Measured: Within 1 month after discharge
5-year overall survival
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study startSep 2017 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2-year Disease-Free SurvivalStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen People's Hospital, Dongguan People's Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Maoming Affiliated Hospital of Southern Medical University
- Responsible party
- Principal investigator, Guowei Ma, Sun Yat-sen University
- Investigators
- Guowei Ma, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203590
- Sponsor's protocol ID
- 3939366
- Status last verified
- Jun 2017
- First submitted
- 21 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Navelbine Carboplatin Versus Gefitinib Neoadjuvant Therapy for Resectable EGFR Mutation Positive Stage Ⅱ-ⅢA NSCLC, Prospective, Randomized, Multicenter, Phase Ⅲ Clinical Trial
- ClinicalTrials.gov ID
- NCT03203590
- Acronym / sponsor ID
- 3939366
- Conditions
- 2-year Disease-Free Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shenzhen People's Hospital, Dongguan People's Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Maoming Affiliated Hospital of Southern Medical University
- Study start
- Sep 2017 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 Jun 2017 (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.
The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation.
Detailed description
Lung cancer is the most common cause of cancer mortality in men and women in the world. LACE meta analysis shows that the 5-year survival rate of post-operation chemotherapy group rose by 5.4%, therefore, adjuvant chemotherapy has been the main treatment after surgery according to National Comprehensive Cancer Network (NCCN) Guideline. But patients have poor compliance due to physical condition after surgery. Compared with adjuvant chemotherapy, neoadjuvant therapy has better patient compliance and tolerance.Targeted therapy, with milder side effect compared with chemotherapy, may be a promising choice to treat NSCLC previously. But to date, there is no enough evidence to support the efficacy and safety of neoadjuvant targeted therapy in patients with EGFR mutation.The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy vs Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable NSCLC patients harboring EGFR mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Navelbine + Carboplatin | Active comparator | Drug: Oral Navelbine + CarboplatinNeoadjuvant therapy Patients with EGFR mutation will be recruited and treated with Navelbine + Carboplatin. |
| Gefitinib | Experimental | Drug: GefitinibNeoadjuvant therapy Patients with EGFR mutation will be recruited and treated with gefitinib. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologic diagnosis of non small cell lung cancer, Stage Ⅱ-ⅢA before treatment
- EGFR Gene mutated
- ECOG 0-1
- liver, kidney and bone marrow are functional healthy，WBC>4.0×109/L，PLT>100×109/L Hb>10g/dL;Cr<1.8mg/dL，bilirubin<1.5mg/dL，GPT<1.5 upper limit of normal
- No vital systems dysfunction or malnutrition
Key exclusion criteria (15 listed)
- Tumor has violated the surrounding tissue organs（T4）
- Preoperative have evidence of distant metastasis including the contralateral mediastinal lymph nodes
- Arrhythmia need anti-arrhythmic treatment（except for β-blockers or digoxin），Symptomatic coronary artery disease and myocardial ischemia (myocardial infarction) in the past 6 months or more than NYHA class II congestive heart failure
- Adverse drug control severe hypertension
- Moderate to severe proteinuria
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 |
|---|---|---|
| Oral Navelbine + CarboplatinAlso: Vinorelbine, CarboplatThe patient will be given Navelbine 60 mg/m2, p.o. day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v. day 1 of every cycle.After 2 cycle we will evaluate their clinical response.Then operable patients will have surgery. | Drug | Oral Navelbine + Carboplatin |
| GefitinibAlso: IressaThe patient will be given Gefitinib 250mg,p.o.,q.d. for 8 weeks.After 8 weeks we evaluate their clinical response.Then operable patients will have surgery. | Drug | Gefitinib |
Primary outcome
2-year disease free survival
Time frame: 2 years
10 secondary outcomes
Objective response rate
Time frame: 1 week before surgery
Pathologic complete response
Time frame: Within 1 month after surgery
Side effects
Time frame: 1 week before surgery
Standard uptake value
Time frame: 1 week before surgery
Tumor reduction rate
Time frame: Within 1 month after surgery
Mediastinal lymph nodes clearance
Time frame: Within 1 month after surgery
Postoperative complications
Time frame: Within 1 month after discharge
R0 resection rate
Time frame: Within 1 month after surgery
Postoperative mortality rate
Time frame: Within 1 month after discharge
5-year overall survival
Time frame: 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Individual participant dataSharing planned: Yes
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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.
Guowei Ma, MD principal investigator
Sun Yat-Sen University Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Navelbine + Carboplatin and Gefitinib in people with 2-year Disease-Free Survival, run by Sun Yat-sen University at 5 sites 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 8 inclusion and 15 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 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Guowei Ma, MD (13501546669, magw@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year disease free survival (time frame: 2 years). 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 Jun 2017.