Non Small Cell Lung CancerPhase 2GONNCT00271271
Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients
A Phase 2 study testing oxaliplatine / gemcitabine / Vinorelbine in people with Non Small Cell Lung Cancer, run by Sanofi at 1 site in France.
Trial summary
Primary: ·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer Secondary: ·To evaluate the toxicity of the combination Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- oxaliplatine / gemcitabine / Vinorelbine
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2003to Oct 2006
- 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-small cell bronchopulmonary cancer established by histological and/or cytological methods;
- Advanced or metastatic disease (stage IIIB or IV);
- At least one measurable lesion with one dimension (>= 20 mm by CT scan or >=10 mm by CT scan) outside of the irradiated area;
- No prior chemotherapy;
- Previous radiotherapy permitted as long as there has been a washout period of at least 4 weeks;
- Age >= 18 years old;
Show all 14Show fewer
- ECOG Performance Status (PS): 0-1;
- Life expectancy >3 months;
- Hepatic and renal functions and blood count satisfactory:
- Blood counts: white blood cells >= 3.0 x 10^9/l, neutrophils >= 1.5 x 10^9/l, platelets >= 150 x 10^9/l, haemoglobin >= 9 g/dl,
- Hepatic function: bilirubin within the limit of the normal upper value, aspartate transaminases (AST) or alanine transaminases (ALT) <= 2.5 times the normal upper value
- Renal function: creatinine clearance (calculated according to Cockroft and Gault) >= 40 ml/min;
- Patients of reproductive age must use an effective contraceptive method;
- Informed consent form signed before any procedure undertaken connected with the study
Who cannot join
- Pregnant or breastfeeding patient;
- Past record of other cancers (excluding basocellular or epidermoid cutaneous carcinoma or cured carcinoma of the cervix);
- Symptomatic cerebral or leptomeningeal metastases;
- Symptomatic peripheral neuropathy > 1 (NCI-CTC grade);
- Presence of a serious disease or medical condition incompatible with the study (at the discretion of the investigator);
- Treatment with another test product or participation in another therapeutic trial in the 4 weeks preceding inclusion in the study;
Show all 9Show fewer
- Concomitant treatment by any other anticancer therapy;
- Concomitant treatment with phenytoin.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer
Primary:
·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer
Secondary:
·To evaluate the toxicity of the combination
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- oxaliplatine / gemcitabine / Vinorelbine
- 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.
oxaliplatine / gemcitabine / VinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
Secondary outcomes (1)
Progression free survival (PFS), Overall survival (OS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startJun 2003
- Study completionOct 2006
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 CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie SEBILLE, Dr, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271271
- Sponsor's protocol ID
- L_8907
- Acronym
- GON
- Status last verified
- Dec 2009
- First submitted
- 29 Dec 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer
- ClinicalTrials.gov ID
- NCT00271271
- Acronym / sponsor ID
- GON / L_8907
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Oct 2006 (actual)
- First posted
- 30 Dec 2005 (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.
Primary:
·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer
Secondary:
·To evaluate the toxicity of the combination
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Non-small cell bronchopulmonary cancer established by histological and/or cytological methods;
- Advanced or metastatic disease (stage IIIB or IV);
- At least one measurable lesion with one dimension (>= 20 mm by CT scan or >=10 mm by CT scan) outside of the irradiated area;
- No prior chemotherapy;
- Previous radiotherapy permitted as long as there has been a washout period of at least 4 weeks;
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding patient;
- Past record of other cancers (excluding basocellular or epidermoid cutaneous carcinoma or cured carcinoma of the cervix);
- Symptomatic cerebral or leptomeningeal metastases;
- Symptomatic peripheral neuropathy > 1 (NCI-CTC grade);
- Presence of a serious disease or medical condition incompatible with the study (at the discretion of the investigator);
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 |
|---|---|---|
| oxaliplatine / gemcitabine / Vinorelbine | Drug | – |
Primary outcome
Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
1 secondary outcome
Progression free survival (PFS), Overall survival (OS)
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 7 Dec 2009.
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Marie SEBILLE, Dr study director
Sanofi
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 oxaliplatine / gemcitabine / Vinorelbine in people with Non Small Cell Lung Cancer, run by Sanofi at 1 site 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 14 inclusion and 9 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 7 Dec 2009. 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 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?
Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.. 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 7 Dec 2009.