NSCLCPhase 3RCTACSCNSCLCNCT03656393
To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma
A Phase 3 study testing Gefitinib, Vinorelbine and Carboplatin in people with NSCLC and EGFR, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Gefitinib, Vinorelbine and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2018to 30 Sep 2020
- 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
- The pathological diagnosis is non-squamous cell carcinoma and non-small cell lung cancer. The pre-treatment tumor stage is stage II-IIIA;
- The gene detects EGFR mutations is positive;
- The age is between 18-70 years;
- ECOG 0-1;
- Liver and kidney function and Bone marrow hematopoiesis is normal;
- There are no serious systemic, respiratory, cardiovascular and other important systemic dysfunctions and severe malnutrition;
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- No other malignant diseases within 5 years;
- Patients who have not received radiotherapy, systemic chemotherapy, or biological therapy;
- Understand the whole process of the trial and voluntarily participate in and sign the informed consent form.
Who cannot join
- The tumor has invaded the surrounding tissue;
- Preoperative evidence suggests that distant metastases of the lesion include contralateral mediastinal lymph node metastasis;
- Arrhythmias require anti-arrhythmia therapy (β-blocker or digoxin Except), symptomatic coronary artery disease or myocardium. Ischemic or congestive heart failure exceeds NYHA class II;
- severe hypertension with poor drug control;
- moderate to severe proteinuria;
- HIV fluHistory of infection or active chronic hepatitis B or C;
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- Malnutrition, decompensation of organ function;
- History of chest radiotherapy;
- Incomplete inflammation of eyes;
- Patients with seizures that need to be treated;
- Interstitial pneumonia;
- Drug abuse and others that may interfere with patients' participation in the study or studyThe assessment of the results has an impact;
- Allergies to the study drug are known or suspected to be allergic to or administered to any drug associated with this test;
- Any instability. The condition of the patient may jeopardize patient safety and compliance;
- Pregnancy or breastfeeding women and having fertility without adequate contraception.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000
wang wei, Doctor, 15914030296, limey@sina.com
wang suo, Doctor, 13590437796, 908611104@qq.com
About this study
Official title: Observational Clinical Trial of Adjuvant Chemotherapy for Non-squamous Cell Carcinoma of Non-small Cell Lung Cancer
The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients.
Read the detailed description
The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients. The purpose is to explore the role of TKI in neoadjuvant therapy, and to further improve disease-free survival (DFS) and pathologic complete remission (pCR) in EGFR-mutant populations; and reduce surgical complications and mortality.
OBJECTIVES: To evaluate the efficacy of oral gefitinib versus neoadjuvant vinorelbine and carboplatin in operable stage II-IIIA EGFR-mutant non-squamous NSCLC patients, with a 2-year disease-free survival rate. 2yDFS).
Secondary objective: To evaluate pCR, 0RR, and other efficacy measures (safety, complete) for oral gefitinib vs. neoadjuvant vinorelbine and carboplatin in patients with operable stage II-IIIA EGFR-mutant non-squamous cell carcinoma NSCLC. Resection rate, tumor regression, mediastinal lymph node clearance, perioperative complications, and mortality rate).
- Being tested
- Gefitinib, Vinorelbine, Carboplatin
- Keywords
- EGFR, NSCLC, Carboplatin, vinorelbine, Gefitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called Iressa
Gefitinib (250 mg, orally, every day) for 56 days
VinorelbineDrug
Also called 5'-noranhydrovinblastine, 5-Nonylthio-8-methylthio-chinolin
Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks
CarboplatinDrug
Also called Paraplatin, Carboplat, Ercar
Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib therapy group | Experimental | Patients are treated with Gefitinib (250 mg, orally, every day) for 56 days and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks. Receives: Drug: Gefitinib |
| Vinorelbine combination therapy group | Active comparator | Patients are treated with vinorelbine (60 mg/m2, orally, Once every three weeks) plus carboplatin (AUC5, intravenously drip, once a week) for 6 weeks and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks. Receives: Drug: Vinorelbine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
2y DFS
2-year disease-free survival
Measured: 2 years
Secondary outcomes (1)
ORR
objective response rates
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start31 Aug 2018 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiu Chen, Doctor, Study director, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656393
- Sponsor's protocol ID
- SZLY2017024
- Acronym
- RCTACSCNSCLC
- Status last verified
- Aug 2018
- First submitted
- 17 Jul 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Trial of Adjuvant Chemotherapy for Non-squamous Cell Carcinoma of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03656393
- Acronym / sponsor ID
- RCTACSCNSCLC / SZLY2017024
- Keywords
- EGFR, NSCLC, Carboplatin, vinorelbine, Gefitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 31 Aug 2018 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 4 Sep 2018 (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 was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients.
Detailed description
The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients. The purpose is to explore the role of TKI in neoadjuvant therapy, and to further improve disease-free survival (DFS) and pathologic complete remission (pCR) in EGFR-mutant populations; and reduce surgical complications and mortality.
OBJECTIVES: To evaluate the efficacy of oral gefitinib versus neoadjuvant vinorelbine and carboplatin in operable stage II-IIIA EGFR-mutant non-squamous NSCLC patients, with a 2-year disease-free survival rate. 2yDFS).
Secondary objective: To evaluate pCR, 0RR, and other efficacy measures (safety, complete) for oral gefitinib vs. neoadjuvant vinorelbine and carboplatin in patients with operable stage II-IIIA EGFR-mutant non-squamous cell carcinoma NSCLC. Resection rate, tumor regression, mediastinal lymph node clearance, perioperative complications, and mortality rate).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gefitinib therapy group | Experimental | Drug: GefitinibPatients are treated with Gefitinib (250 mg, orally, every day) for 56 days and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks. |
| Vinorelbine combination therapy group | Active comparator | Drug: Vinorelbine, Drug: CarboplatinPatients are treated with vinorelbine (60 mg/m2, orally, Once every three weeks) plus carboplatin (AUC5, intravenously drip, once a week) for 6 weeks and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The pathological diagnosis is non-squamous cell carcinoma and non-small cell lung cancer. The pre-treatment tumor stage is stage II-IIIA;
- The gene detects EGFR mutations is positive;
- The age is between 18-70 years;
- ECOG 0-1;
- Liver and kidney function and Bone marrow hematopoiesis is normal;
Key exclusion criteria (15 listed)
- The tumor has invaded the surrounding tissue;
- Preoperative evidence suggests that distant metastases of the lesion include contralateral mediastinal lymph node metastasis;
- Arrhythmias require anti-arrhythmia therapy (β-blocker or digoxin Except), symptomatic coronary artery disease or myocardium. Ischemic or congestive heart failure exceeds NYHA class II;
- severe hypertension with poor drug control;
- 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 |
|---|---|---|
| GefitinibAlso: IressaGefitinib (250 mg, orally, every day) for 56 days | Drug | Gefitinib therapy group |
| VinorelbineAlso: 5'-noranhydrovinblastine, 5-Nonylthio-8-methylthio-chinolinVinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks | Drug | Vinorelbine combination therapy group |
| CarboplatinAlso: Paraplatin, Carboplat, ErcarCarboplatin (AUC5, intravenously drip, once a week) for 6 weeks | Drug | Vinorelbine combination therapy group |
Primary outcome
2y DFS
Time frame: 2 years
2-year disease-free survival
1 secondary outcome
ORR
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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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.
Qiu Chen, Doctor study director
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gefitinib, Vinorelbine and Carboplatin in people with NSCLC and EGFR, run by Shenzhen People's 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 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 4 Sep 2018. 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 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 Wang Lingwei, Doctor (15914030269, limey@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2y DFS (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 4 Sep 2018.