Non-small Cell Lung Cancer MetastaticPhase 2BUCiLNCT01705184
Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.
A Phase 2 study testing Cisplatin, Bevacizumab and Pemetrexed in people with Non-small Cell Lung Cancer Metastatic and Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 12 sites in France.
Trial summary
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression. In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic, Nonsquamous Nonsmall Cell Neoplasm of Lung
- What is being tested?
- Cisplatin, Bevacizumab and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 12 sitesFrance
- Study dates
- Dec 2012to Oct 2017
- 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
- Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
- Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
- Measurable disease (recist criteria)
- Age ≥18 years
- PS0 or 1
Who cannot join
- Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
- History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
- Tumor invaded the big vessels or the proximal visible in TDM.
- History of adjuvant or neoadjuvant chemotherapy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Avignon - Institut Sainte-Catherine
Avignon, 84918
Caen - Centre François Baclesse
Caen, 14000
Caen - CHU Côte de Nacre
Caen, 14000
Centre Hospitalier
Chauny
CH du Mans
Le Mans
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
Marseille
Mulhouse - CH
Mulhouse, 68000
Nantes - Centre René Gauducheau
Nantes, 44805
Hopital Tenon - Pneumologie
Paris, 75020
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, 69495
Rennes - CHU
Rennes, 35033
Strasbourg - NHC
Strasbourg, 63000
About this study
Official title: Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
The question is to know if this strategy is feasible in lung cancer.
- Being tested
- Cisplatin, Bevacizumab, Pemetrexed
- Keywords
- Stop and go, Non-small cell lung cancer, Non-squamous, Bevacizumab, IFCT
- 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.
CisplatinDrug
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
BevacizumabDrug
7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
PemetrexedDrug
500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.
| Study group | Role | What they receive |
|---|---|---|
| BUCiL | Experimental | Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2
Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control Receives: Drug: Cisplatin; Drug: Bevacizumab; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
Measured: After 3 cycles
Secondary outcomes (4)
Control rate after the 2nd sequence
Measured: After 3 cycles
Response rate after the 1st sequence
Measured: After 3 cycles
Overall survival
Measured: 12 months
Quality of life
Measured: During Sequence 2 : at the beginning and after 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaafar BENNOUNA, MD, Principal investigator, Centre René Gauducheau - Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705184
- Sponsor's protocol ID
- IFCT-1102
- Other IDs
- 2012-002647-18
- Acronym
- BUCiL
- Status last verified
- Mar 2023
- First submitted
- 5 Oct 2012
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.
PubMed 16421419Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.
PubMed 22341744Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.
PubMed 19786657
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.
- ClinicalTrials.gov ID
- NCT01705184
- Acronym / sponsor ID
- BUCiL / IFCT-1102
- Keywords
- Stop and go, Non-small cell lung cancer, Non-squamous, Bevacizumab, IFCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 12 Oct 2012 (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.
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
The question is to know if this strategy is feasible in lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BUCiL | Experimental | Drug: Cisplatin, Drug: Bevacizumab, Drug: PemetrexedSequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
- Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
- Measurable disease (recist criteria)
- Age ≥18 years
- PS0 or 1
Key exclusion criteria (4 listed)
- Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
- History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
- Tumor invaded the big vessels or the proximal visible in TDM.
- History of adjuvant or neoadjuvant chemotherapy
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 |
|---|---|---|
| Cisplatin75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence | Drug | BUCiL |
| Bevacizumab7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence | Drug | BUCiL |
| Pemetrexed500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence. | Drug | BUCiL |
Primary outcome
Feasibility
Time frame: After 3 cycles
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
4 secondary outcomes
Control rate after the 2nd sequence
Time frame: After 3 cycles
Response rate after the 1st sequence
Time frame: After 3 cycles
Overall survival
Time frame: 12 months
Quality of life
Time frame: During Sequence 2 : at the beginning and after 3 cycles
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 13 Mar 2023.
- Background: PubMed 16421419Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.
- Background: PubMed 22341744Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.
- Background: PubMed 19786657Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.
- IFCT websiteLink provided by the sponsor.
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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.
Jaafar BENNOUNA, MD principal investigator
Centre René Gauducheau - Nantes
12 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 Cisplatin, Bevacizumab and Pemetrexed in people with Non-small Cell Lung Cancer Metastatic and Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 12 sites in France.
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 5 inclusion and 4 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 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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?
Feasibility (time frame: After 3 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01705184, which also lists 3 linked publications.
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 13 Mar 2023.