Non-small Cell Lung Cancer Stage IIIBPhase 2ONC-MANILA12NCT02176369
Maintenance Low Dose Oral Navelbine In Patients With Non Small Cell Lung Cancer - MA.NI.LA Trial
A Phase 2 study testing Vinorelbine in people with Non-small Cell Lung Cancer Stage IIIB and Non-small Cell Lung Cancer Stage IV, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 20 sites in Italy.
Trial summary
Non Small Cell Lung Cancer (NSCLC) represents the first cancer related cause of death worldwide with 1.4 millions of deaths every years. Current standard therapies include platinum-containing drugs but at one year from diagnosis the survival rate is still low (30-40%) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV
- What is being tested?
- Vinorelbine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 20 sitesItaly
- Study dates
- Feb 2013to 27 Oct 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
- Signed and dated approved ICF
- Histologically or cytologically confirmed diagnosis NSCLC diagnosis
- Stage IV (using AJCC 7th edition, or wet IIIb / IV using the 6th edition), or recurrent locally advanced disease not amenable to radiation or surgery with curative intent and not amenable to concurrent chemoradiation
- Patients with stable disease, after four-six cycles of platinum-based chemotherapy as first line therapy. Patients with partial or complete response during first line chemotherapy according to RECIST criteria can be enrolled provided that they have stable disease at the study entry.
- Patients who may have received adjuvant treatment (containing also vinorelbine) at least 6 mos before study entry
- ECOG performance status 0-2
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- Adequate bone marrow reserve as measured by ANC ≥ 1500/mm3, hemoglobin ≥ 9 g/dL, platelet count ≥ 100,000/μL, ≥ 1 week after last transfusion of blood products and/or last dose of hematopoietic growth factor
- Prothrombin time (PT) or INR or aPTT ≤ 1.5 x ULN
- Calculated creatinine clearance ≥ 30 mL/min (Cockcroft and Gault Formula)
- AST (SGOT) and ALT (SGPT) < 2.5 x ULN, AST and ALT < 5 x ULN (if documented liver metastases)
- Serum bilirubin < 2.0 mg/dL (patients with Gilbert's syndrome: serum bilirubin ≤ 3 x ULN
- Alkaline phosphatase < 2.5 x ULN (patients with documented liver or bone metastases, alkaline phosphatase ≤ 5 x ULN)
- No other obvious related major organ toxicities which would compromise the patient's ability to participate in a clinical trial
- Allowed prior radiation therapy for local or locally advanced disease providing that any clinically significant adverse effects associated with prior therapy have recovered to Grade 1 or less
- Women of childbearing potential must have a negative serum pregnancy test and agree to use effective birth control during the trial and for 12 wks after the last treatment dose
- Males must agree to use effective birth control for themselves or their partner during the trial and for 12 wks after the last treatment dose
- Life expectancy of at least 12 wks
- Male or female, age ≥18
Who cannot join
- Patients who have received induction therapy with platinum obtaining progressive disease
- Patients who can benefit from pemetrexed maintenance treatment (adenocarcinoma and ECOG PS 0-1) should be excluded. Enrollment in the trial is permitted for patients who refuse maintenance with pemetrexed or in case of clinical contraindications to pemetrexed therapy (for example renal failure, creatinine clearance ≤ 45 mL/min)
- Patients who have received, or are scheduled to receive, single agent or combination therapy consisting of chemotherapy, targeted, biological, investigational, hormonal as maintenance treatment
- Previous treatment for metastatic disease with chemotherapy containing oral or i.v. vinorelbine formulation
- Last dose of induction chemotherapy < 21 d prior to randomization or > 42 d prior to randomization
- Concurrent treatment with other experimental drugs.
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- Radiation therapy within 3 wks prior to randomization (palliative radiation therapy is allowed, provided that sites of bone marrow production, i.e., iliac crests are not in the radiation field)
- Major surgery within 4 wks prior to first study drug administration
- Active central nervous system (CNS) metastatic disease. Patients with stable CNS disease following completion of radiation therapy and/or surgery are eligible
- Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
- Malabsorption syndrome or any other disorder affecting gastrointestinal absorption
- Clinically significant infection
- Clinically significant cardiovascular disease or condition including: congestive heart failure (CHF) requiring therapy, need for anti-arrhythmic therapy for a ventricular arrhythmia, severe conduction disturbance, angina pectoris requiring therapy, medically uncontrolled hypertension per the Investigator's discretion, myocardial infarction within 6 mos prior to first study drug administration, New York Heart Association Class II, III, or IV cardiovascular disease
- Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements 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
- History of neoplasm other than curatively treated non-melanoma skin cancer or other carcinoma in situ, that has been resected, unless that prior malignancy was diagnosed and definitely treated at least 3 ys previously with no subsequent evidence of recurrence
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Ospedale di Gesù Fatebenefratelli
Benevento, BN, 82100
ASP di Bolzano - Comprensorio sanitario di Bolzano
Bolzano, BZ, 39100
ASL Brindisi - Stabilimento Ospedaliero Di Summa-Perrino
Brindisi, BR, 72100
A.O. Ospedale di Circolo di Busto Arsizio
Busto Arsizio, VA, 21052
A. Ospedaliero-Universitaria Policlinico Vittorio Enmanuele
Catania, CT, 95123
Ospedale Civile SS. Annunziata
Chieti, CH, 66100
A.O. Villa Scassi
Genova, GE, 16149
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, 20133
A.O. V. Cervello
Palermo, PA, 90146
Casa di Cura La Maddalena
Palermo, PA, 90146
Casa di Cura Dott. Pederzoli
Peschiera del Garda, VR, 37019
AUSL Piacenza - Ospedale Guglielmo da Saliceto
Piacenza, PC, 29121
A.O. Santa Maria Degli Angeli
Pordenone, PN, 33170
Azienda USL 4 Prato - O.C. Misericordia e Dolce
Prato, PO, 59100
Azienda Ulss18 - Ospedale S.M. della Misericordia
Rovigo, RO, 45100
Ospedale Morelli
Sondalo, SO, 23100
A.O. Valtellina e Valchiavenna - Ospedale di Sondrio
Sondrio, SO, 23100
Ospedale di Circolo e Fondazione Macchi
Varese, VA, 21100
AUSL Viterbo - Ospedale di Belcolle
Viterbo, VT, 01100
A.O. Ospedale di Circolo di Melegnano - P.O. Vizzolo Predabissi
Vizzolo Predabissi, MI, 20070
About this study
Official title: Maintenance Metronomic Per OS Navelbine In Advanced NSCLC Patients After Previous Platinum Based Chemotherapy: A Multicenter Randomized Best Supportive Care Controlled Phase II Study - MA.NI.LA. Trial
Non Small Cell Lung Cancer (NSCLC) represents the first cancer related cause of death worldwide with 1.4 millions of deaths every years. Current standard therapies include platinum-containing drugs but at one year from diagnosis the survival rate is still low (30-40%) .
The purpose of this study is to evaluate the role of a platinum-free drug, named Vinorelbine, administered by the so called "metronomic schedule" in order to prolong the progression free survival of patients.
Read the detailed description
Systemic therapy remains the mainstay of treatment of advanced stage NSCLC. Combination chemotherapy with a platinum-based regimen has emerged as standard therapy for patients with advanced stage disease. Observations supported by the findings of several clinical trial, established the notion that an efficacy plateau had been reached in advanced stage NSCLC patients treated with platinum-containing drugs.
Recent phase III trials suggest the benefit of "switch" and "continuing" maintenance treatment with different drugs. As "switched therapy", Vinorelbine has been selected on the base of its anti-mitotic role. In fact, the use of anti-mitotic drugs at lower dose but with higher frequency (metronomic schedule) seems to augment the anti-angiogenetic effect of this kind of drugs, thus augmenting the efficacy of the therapy.
Therefore, the purpose of the current study is to evaluate the role of a "switched maintenance" with oral vinorelbine administered as a metronomic schedule in terms of Progression Free Survival (PFS) in advanced NSCLC patients with stable disease after first line platinum based chemotherapy.
- Being tested
- Vinorelbine
- Keywords
- Non small cell lung cancer (NSCLC), Lung tumor in advanced phase
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Navelbine
Capsule soft (20/30 mg) - 50 mg three times a week (monday, wednesday and friday) for a three weeks cycle (then recycled the next week at the same doses)Treatment will be continued until progression, unacceptable toxicity or death.
| Study group | Role | What they receive |
|---|---|---|
| vinorelbine | Experimental | 50 mg three times a week for a three weeks cycle Receives: Drug: Vinorelbine |
| Close observation/Best Supportive Care | No intervention | Close observation/Best Supportive Care (BSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS: defined as the time from the date of randomization to the date of first documentation of progression, or of death due to any cause, whichever comes first.
Measured: Assessed at every 2 cycles (6 wks), 28d after last dose intake and, for patients discontinuing vinolbine for reason other than PD, every 6 wks during Follow Up, up to 18 mos after the enrollment of the Last Patient (LPI)
Secondary outcomes (6)
Overall Survival (OS)
OS: defined as the time from the date of randomization to the date of death from any cause or the last date the patient was known to be alive.
Measured: Assessed at every cycle (3wks), 28d after last dose intake and, during Follow Up, every 3 mos except for patients discontinuing vinolbine for reason other than PD whose assessment is every 6 wks, up to 18 mos after LPI
Objective Tumor Response Rate (ORR, CR+PR)
ORR, CR+PR: defined as the proportion of patients with measurable disease at baseline achieving partial or complete overall best response according to RECIST version 1.1 criteria.
Measured: Assessed at every 2 cycles (6wks), 28d after last dose intake and, during Follow Up, every 3 mos except for patients discontinuing vinolbine for reason other than PD whose assessment is every 6 wks, up to 18 mos after LPI
Duration of Response (only in patients in CR or PR)
Duration of Response (only in patients in CR or PR): defined as the time from the date of the first documentation of confirmed objective tumor response to the date of first documentation of objective tumor progression, objective tumor recurrence, or of death due to progressive disease, whichever comes first.
Measured: Assessed every two cycles (6wks), 28d after last dose intake and, during Follow Up, every 3 mos except for patients discontinuing vinolbine for reason other than PD whose assessment is every 6 wks, up to 18 mos after LPI
Duration of Post Progression Survival
Duration of Post Progression Survival: defined as the time from the date of first documentation of objective tumor progression to the date of death from any cause or the last date the patient was known to be alive.
Measured: Assessed at 28d after last dose intake and, during Follow Up, every 3 mos except for patients discontinuing vinolbine for reason other than PD whose assessment is every 6 wks, up to 18 mos after LPI
Quality of Life (QoL) according to EORTC QLC30, EORTC QOL-LC13
Measured: Assessed at every 2 cycles (6wks), 28d after last dose intake and, for patients discontinuing vinolbine for reason other than PD, every 6 wks during Follow Up, up to 18 mos after LPI
Overall Safety Profile
Overall Safety Profile, characterized by type, frequency, severity [graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0], timing and relationship to study therapy of adverse events and laboratory abnormalities.
Measured: Assessed at every cycle (3wks) and 28d after last dose intake up to 18 months after LPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completion27 Oct 2018
- Study completion27 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIBStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Lombardia
- Responsible party
- Sponsor
- Investigators
- Marco Platania, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoAlessandro Bertolini, MD, Principal investigator, A.O. Valtellina e Valchiavenna - Ospedale di SondrioAndrea De Monte, Principal investigator, A.O. Ospedale di Circolo di Melegnano - P.O. Vizzolo PredabissiLuigi Cavanna, MD, Principal investigator, AUSL Piacenza - Ospedale Guglielmo da SalicetoMarco Bregni, MD, Principal investigator, A.O. Ospedale di Circolo di Busto ArsizioYasmina Modena, MD, Principal investigator, Azienda Ulss18 - Ospedale S.M. della Misericordia - RovigoFabrizio Nelli, MD, Principal investigator, AUSL Viterbo - Ospedale di BelcolleDaniele Pozzessere, MD, Principal investigator, Azienda USL 4 Prato - O.C. Misericordia e Dolce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176369
- Sponsor's protocol ID
- ONC-MANILA12
- Other IDs
- 2012-001103-21
- Acronym
- ONC-MANILA12
- Status last verified
- Apr 2019
- First submitted
- 11 Jun 2014
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Metronomic Per OS Navelbine In Advanced NSCLC Patients After Previous Platinum Based Chemotherapy: A Multicenter Randomized Best Supportive Care Controlled Phase II Study - MA.NI.LA. Trial
- ClinicalTrials.gov ID
- NCT02176369
- Acronym / sponsor ID
- ONC-MANILA12 / ONC-MANILA12
- Keywords
- Non small cell lung cancer (NSCLC), Lung tumor in advanced phase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Regione Lombardia
- Study start
- Feb 2013 (actual)
- Primary completion
- 27 Oct 2018 (actual)
- Study completion
- 27 Oct 2018 (actual)
- First posted
- 27 Jun 2014 (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.
Non Small Cell Lung Cancer (NSCLC) represents the first cancer related cause of death worldwide with 1.4 millions of deaths every years. Current standard therapies include platinum-containing drugs but at one year from diagnosis the survival rate is still low (30-40%) .
The purpose of this study is to evaluate the role of a platinum-free drug, named Vinorelbine, administered by the so called "metronomic schedule" in order to prolong the progression free survival of patients.
Detailed description
Systemic therapy remains the mainstay of treatment of advanced stage NSCLC. Combination chemotherapy with a platinum-based regimen has emerged as standard therapy for patients with advanced stage disease. Observations supported by the findings of several clinical trial, established the notion that an efficacy plateau had been reached in advanced stage NSCLC patients treated with platinum-containing drugs.
Recent phase III trials suggest the benefit of "switch" and "continuing" maintenance treatment with different drugs. As "switched therapy", Vinorelbine has been selected on the base of its anti-mitotic role. In fact, the use of anti-mitotic drugs at lower dose but with higher frequency (metronomic schedule) seems to augment the anti-angiogenetic effect of this kind of drugs, thus augmenting the efficacy of the therapy.
Therefore, the purpose of the current study is to evaluate the role of a "switched maintenance" with oral vinorelbine administered as a metronomic schedule in terms of Progression Free Survival (PFS) in advanced NSCLC patients with stable disease after first line platinum based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vinorelbine | Experimental | Drug: Vinorelbine50 mg three times a week for a three weeks cycle |
| Close observation/Best Supportive Care | No intervention | –Close observation/Best Supportive Care (BSC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed and dated approved ICF
- Histologically or cytologically confirmed diagnosis NSCLC diagnosis
- Stage IV (using AJCC 7th edition, or wet IIIb / IV using the 6th edition), or recurrent locally advanced disease not amenable to radiation or surgery with curative intent and not amenable to concurrent chemoradiation
- Patients with stable disease, after four-six cycles of platinum-based chemotherapy as first line therapy. Patients with partial or complete response during first line chemotherapy according to RECIST criteria can be enrolled provided that they have stable disease at the study entry.
- Patients who may have received adjuvant treatment (containing also vinorelbine) at least 6 mos before study entry
Key exclusion criteria (15 listed)
- Patients who have received induction therapy with platinum obtaining progressive disease
- Patients who can benefit from pemetrexed maintenance treatment (adenocarcinoma and ECOG PS 0-1) should be excluded. Enrollment in the trial is permitted for patients who refuse maintenance with pemetrexed or in case of clinical contraindications to pemetrexed therapy (for example renal failure, creatinine clearance ≤ 45 mL/min)
- Patients who have received, or are scheduled to receive, single agent or combination therapy consisting of chemotherapy, targeted, biological, investigational, hormonal as maintenance treatment
- Previous treatment for metastatic disease with chemotherapy containing oral or i.v. vinorelbine formulation
- Last dose of induction chemotherapy < 21 d prior to randomization or > 42 d prior to randomization
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 |
|---|---|---|
| VinorelbineAlso: NavelbineCapsule soft (20/30 mg) - 50 mg three times a week (monday, wednesday and friday) for a three weeks cycle (then recycled the next week at the same doses)Treatment will be continued until progression, unacceptable toxicity or death. | Drug | vinorelbine |
Primary outcome
Progression Free Survival (PFS)
Time frame: Assessed at every 2 cycles (6 wks), 28d after last dose intake and, for patients discontinuing vinolbine for reason other than PD, every 6 wks during Follow Up, up to 18 mos after the enrollment of the Last Patient (LPI)
PFS: defined as the time from the date of randomization to the date of first documentation of progression, or of death due to any cause, whichever comes first.
6 secondary outcomes
Overall Survival (OS)
Time frame: Assessed at every cycle (3wks), 28d after last dose intake and, during Follow Up, every 3 mos except for patients discontinuing vinolbine for reason other than PD whose assessment is every 6 wks, up to 18 mos after LPI
Objective Tumor Response Rate (ORR, CR+PR)
Time frame: Assessed at every 2 cycles (6wks), 28d after last dose intake and, during Follow Up, every 3 mos except for patients discontinuing vinolbine for reason other than PD whose assessment is every 6 wks, up to 18 mos after LPI
Duration of Response (only in patients in CR or PR)
Time frame: Assessed every two cycles (6wks), 28d after last dose intake and, during Follow Up, every 3 mos except for patients discontinuing vinolbine for reason other than PD whose assessment is every 6 wks, up to 18 mos after LPI
Duration of Post Progression Survival
Time frame: Assessed at 28d after last dose intake and, during Follow Up, every 3 mos except for patients discontinuing vinolbine for reason other than PD whose assessment is every 6 wks, up to 18 mos after LPI
Quality of Life (QoL) according to EORTC QLC30, EORTC QOL-LC13
Time frame: Assessed at every 2 cycles (6wks), 28d after last dose intake and, for patients discontinuing vinolbine for reason other than PD, every 6 wks during Follow Up, up to 18 mos after LPI
Overall Safety Profile
Time frame: Assessed at every cycle (3wks) and 28d after last dose intake up to 18 months after LPI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
Marco Platania, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Alessandro Bertolini, MD principal investigator
A.O. Valtellina e Valchiavenna - Ospedale di Sondrio
Andrea De Monte principal investigator
A.O. Ospedale di Circolo di Melegnano - P.O. Vizzolo Predabissi
20 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 Vinorelbine in people with Non-small Cell Lung Cancer Stage IIIB and Non-small Cell Lung Cancer Stage IV, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 20 sites in Italy.
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 18 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: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression Free Survival (PFS) (time frame: Assessed at every 2 cycles (6 wks), 28d after last dose intake and, for patients discontinuing vinolbine for reason other than PD, every 6 wks during Follow Up, up to 18 mos after the enrollment of the Last Patient (LPI)). 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 22 Apr 2019.