Lung Neoplasm MalignantPhase 2NCT02985203
Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer
A Phase 2 study testing Vinorelbine Oral in people with Lung Neoplasm Malignant, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in Patients with advanced Non-Small Cell Lung Cancer. The study comprises two stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- Vinorelbine Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Apr 2018
- 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
- Men or women aged ≥ 18 years with life expectancy ≥ 6 months
- Histologically or cytologically confirmed advanced (Stage III B - IV) NSCLC which has not received antineoplastic treatment and not suitable for radical treatment, including those have been resected more than 1 year before signing informed consent form (ICF) then metastasized or relapsed and currently requiring chemotherapy
- With no history of cancer other than in situ uterine cervix cancer or skin basal cell carcinoma with no active disease within 5 years prior to signing the ICF
- With at least one measurable target lesion(s) according to RECIST 1.1
- Adequate hematopoietic function
- Adequate hepatic and renal function
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to take an adequate contraceptive measure
- Men who have sexual life and have a wife of child-bearing age must agree to take an adequate contraceptive measure during and for 12 weeks after the last treatment with Navelbine
- Signed written informed consent
- Able to comply with the protocol
Who cannot join
- Non-small Cell Lung Cancer with positive sensitizing epidermal growth factor receptor (EGFR) mutation positive or anaplastic lymphoma kinase (ALK) fusion oncogene, or with unknown EGFR/ALK status
- Resectable Non-Small Cell Lung Cancer or suitable for radical radiotherapy/ chemotherapy
- Patients with medical conditions that the only manifestation is hydrothorax, ascites, bone lesions or other unmeasurable diseases
- Symptomatic CNS metastasis (CNS metastasis which has received radiotherapy or surgery and symptom has been stable for more than 4 weeks could be enrolled)
- With invasive malignancies except lung cancer
- Inadequate hematopoietic function:
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- Neutrophil <1.5*109/L;
- Hb < 100g/L;
- platelet count (PLT) <100*109/L
- Inadequate hepatic or renal function:
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline phosphatase (AKP)>2.5 upper limit of normal (ULN) in patients without liver or bone metastasis
- AST and/or ALT >1.5 ULN with AKP>2.5 ULN
- AKP>5 ULN in patients with bone metastasis
- ALT/AST>5 ULN in patients with liver metastasis
- Total bilirubin > 1.5 ULN
- Serum creatinine >1.5 ULN
- Calculated creatinine clearance below 60ml/min (Cockcroft and Gault formula)
- Blood calcium>ULN
- Patient is pregnant or nursing
- Patients with psychiatric disorder or other disease leading to incompliance to the therapy
- Known hypersensitivity to any ingredient of the regimen
- Treatment with any investigational drug within 30 days before the beginning of treatment with study drug
- Malabsorption syndrome or any other disorder affecting gastrointestinal absorption
- Any other severe, acute, or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Investigate the Efficacy and Safety of Combination of Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Patients With Advanced Non-Small Cell Lung Cancer
This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in Patients with advanced Non-Small Cell Lung Cancer.
The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B).
Read the detailed description
In the 1st stage (Week 1-12), all patients will receive combination chemotherapy, i.e. Platinum and Navelbine, for 4 cycles. The regimen is:
Navelbine oral 60mg/m2 d1,8 the first cycle; oral 80mg/m2 day1,8 in sequential cycles q3w plus cisplatin: 75mg/m2 d1 q3w.
In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no PD will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B). The allocation will be done in sequence at each site, i.e., the first subject who complete the combination chemotherapy with acceptable tolerance and have no PD will be allocated to Arm A, and the second will be allocated to Arm B, and so on. Arm A will continue with oral Navelbine 3 times weekly as maintenance therapy, up to 12 weeks, or till progression, unacceptable toxicity or death occurred. As contrast, Arm B will receive other therapy as per the physician's choice.
Arm A: Navelbine oral 50mg three times per week (Day 1, 3, 5 of each week ) Arm B: Physician's choice (other than Navelbine oral) computed tomography (CT) or magnetic resonance imaging (MRI) will be done at the screening visit, Week 7, Week 13 (before the initiation of maintenance therapy), Week 19 (after 6 weeks of maintenance therapy), and Week 25 (after 12 weeks of maintenance therapy), to evaluate the tumor response. The Disease Control Rate (proportion of patients in complete response (CR), partial response (PR) or stable disease (SD)) after 6 weeks and 12 weeks of maintenance therapy will be evaluated separately for the 2 arms. And Arm B is for observational study only, and will provide rationale for control group selecting in future study.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Vinorelbine Oral
- Keywords
- lung cancer, vinorelbine, metronomic chemotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinorelbine OralDrug
Also called Navelbine
Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine
| Study group | Role | What they receive |
|---|---|---|
| Vinorelbine oral | Experimental | Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine. Receives: Drug: Vinorelbine Oral |
| Physician's choice | No intervention | Observation or maintenance therapy other than orla navelbine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate during maintenance
Measured: 12 weeks
Secondary outcomes (3)
Response rate during maintenance
Measured: 12 weeks
Duration of response
Measured: 8 months
progression-free survival
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: No participants were enrolled as schedule.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasm MalignantStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhen Wang, PhD,MD, Principal investigator, Guangdong General Hospital&Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985203
- Sponsor's protocol ID
- CTONG 1512
- Status last verified
- Jun 2018
- First submitted
- 29 Nov 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate the Efficacy and Safety of Combination of Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02985203
- Acronym / sponsor ID
- CTONG 1512
- Conditions
- Lung Neoplasm Malignant
- Keywords
- lung cancer, vinorelbine, metronomic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No participants were enrolled as schedule.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 Dec 2016 (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.
This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in Patients with advanced Non-Small Cell Lung Cancer.
The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B).
Detailed description
In the 1st stage (Week 1-12), all patients will receive combination chemotherapy, i.e. Platinum and Navelbine, for 4 cycles. The regimen is:
Navelbine oral 60mg/m2 d1,8 the first cycle; oral 80mg/m2 day1,8 in sequential cycles q3w plus cisplatin: 75mg/m2 d1 q3w.
In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no PD will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B). The allocation will be done in sequence at each site, i.e., the first subject who complete the combination chemotherapy with acceptable tolerance and have no PD will be allocated to Arm A, and the second will be allocated to Arm B, and so on. Arm A will continue with oral Navelbine 3 times weekly as maintenance therapy, up to 12 weeks, or till progression, unacceptable toxicity or death occurred. As contrast, Arm B will receive other therapy as per the physician's choice.
Arm A: Navelbine oral 50mg three times per week (Day 1, 3, 5 of each week ) Arm B: Physician's choice (other than Navelbine oral) computed tomography (CT) or magnetic resonance imaging (MRI) will be done at the screening visit, Week 7, Week 13 (before the initiation of maintenance therapy), Week 19 (after 6 weeks of maintenance therapy), and Week 25 (after 12 weeks of maintenance therapy), to evaluate the tumor response. The Disease Control Rate (proportion of patients in complete response (CR), partial response (PR) or stable disease (SD)) after 6 weeks and 12 weeks of maintenance therapy will be evaluated separately for the 2 arms. And Arm B is for observational study only, and will provide rationale for control group selecting in future study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vinorelbine oral | Experimental | Drug: Vinorelbine OralOral Navelbine plus Cisplatin followed by metronomic oral vinorelbine. |
| Physician's choice | No intervention | –Observation or maintenance therapy other than orla navelbine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men or women aged ≥ 18 years with life expectancy ≥ 6 months
- Histologically or cytologically confirmed advanced (Stage III B - IV) NSCLC which has not received antineoplastic treatment and not suitable for radical treatment, including those have been resected more than 1 year before signing informed consent form (ICF) then metastasized or relapsed and currently requiring chemotherapy
- With no history of cancer other than in situ uterine cervix cancer or skin basal cell carcinoma with no active disease within 5 years prior to signing the ICF
- With at least one measurable target lesion(s) according to RECIST 1.1
- Adequate hematopoietic function
Key exclusion criteria (24 listed)
- Non-small Cell Lung Cancer with positive sensitizing epidermal growth factor receptor (EGFR) mutation positive or anaplastic lymphoma kinase (ALK) fusion oncogene, or with unknown EGFR/ALK status
- Resectable Non-Small Cell Lung Cancer or suitable for radical radiotherapy/ chemotherapy
- Patients with medical conditions that the only manifestation is hydrothorax, ascites, bone lesions or other unmeasurable diseases
- Symptomatic CNS metastasis (CNS metastasis which has received radiotherapy or surgery and symptom has been stable for more than 4 weeks could be enrolled)
- With invasive malignancies except lung cancer
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 |
|---|---|---|
| Vinorelbine OralAlso: NavelbineOral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine | Drug | Vinorelbine oral |
Primary outcome
Disease control rate during maintenance
Time frame: 12 weeks
3 secondary outcomes
Response rate during maintenance
Time frame: 12 weeks
Duration of response
Time frame: 8 months
progression-free survival
Time frame: 8 months
Results and safety
The study was stopped early (reason given: No participants were enrolled as schedule.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Zhen Wang, PhD,MD principal investigator
Guangdong General Hospital&Guangdong Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine Oral in people with Lung Neoplasm Malignant, run by Guangdong Association of Clinical Trials 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 11 inclusion and 24 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: stopped early, as of the sponsor's last update on 12 Mar 2020. 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 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?
The study was stopped early (reason given: No participants were enrolled as schedule.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate during maintenance (time frame: 12 weeks). 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 12 Mar 2020.