Stage IV Non-small Cell Lung CancerPhase 3NCT00300586
IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer
A Phase 3 study testing observation, gemcitabine and erlotinib in people with Stage IV Non-small Cell Lung Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer
- What is being tested?
- observation, gemcitabine and erlotinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 842 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Mar 2011
- 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
- Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted.
- Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement.
- Measurable disease according to the RECIST criteria.
- Prior radiotherapy authorized except for irradiation concerning measurable disease.
- Age >18 and < 70 years.
- PS < 2.
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- Normal hepatic function : serum bilirubin < 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) < 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be < 5 x ULN.
- Creatinine clearance > 60 mL/min.
- Granulocyte count > 1,5 giga/L, platelet count > 100 giga/L.
- Life expectancy > 12 weeks.
- Written (signed) informed consent for use of tumors samples.
- Written (signed) informed consent to participate in the sudy.
Who cannot join
- Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma.
- PS > 1.
- Prior chemotherapy other than cisplatin-gemcitabine.
- Prior therapy with EGFR inhibitor (e.g. monoclonal antibody).
- No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital.
- Concomitant radiotherapy except for localized bone irradiation.
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- Symptomatic brain metastases.
- Superior vena cava syndrome.
- Any unstable systemic disease : significant cardiovascular disease including myocardial infarction within the previous year, active infection, significant hepatic or renal disease.
- Pre-existing interstitial lung disease.
- Any inflammatory changes of the surface of the eyes.
- Psychiatric disease with inability to understand the study or to comply with follow-up procedures.
- Grade > or = 2 peripheral neuropathy.
- Any other malignancies within 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
- Pregnant or lactating women ; patients with reproductive potential must use effective contraception.
- Inability to comply with follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib
The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :
- Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
- Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Being tested
- observation, gemcitabine, erlotinib
- Keywords
- Non-small cell lung cancer ;, metastatic ;, chemotherapy ;, erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationDrug
observation, second line chemotherapy if progression
gemcitabineDrug
1250 mg/m² D1, D8 q21 days
erlotinibDrug
150 mg daily
| Study group | Role | What they receive |
|---|---|---|
| A (supervision) | Sham comparator | medical supervision, second line chemotherapy if progression Receives: Drug: observation |
| B (gemcitabicine) | Active comparator | Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression Receives: Drug: gemcitabine |
| C (Erlotinib) | Experimental | Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression Receives: Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival since randomization
Measured: time until progression
Secondary outcomes (3)
Overall survival,
Measured: no time limit
toxicity (NCIC-CTC 3.0),
Measured: time until progression
quality of life (as assessed by LCSS).
Measured: until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurice Pérol, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300586
- Sponsor's protocol ID
- 2005.386
- Status last verified
- Dec 2011
- First submitted
- 6 Mar 2006
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perol M, Chouaid C, Perol D, Barlesi F, Gervais R, Westeel V, Crequit J, Lena H, Vergnenegre A, Zalcman G, Monnet I, Le Caer H, Fournel P, Falchero L, Poudenx M, Vaylet F, Segura-Ferlay C, Devouassoux-Shisheboran M, Taron M, Milleron B. Randomized, phase III study of gemcitabine or erlotinib maintenance therapy versus observation, with predefined second-line treatment, after cisplatin-gemcitabine induction chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2012 Oct 1;30(28):3516-24. doi: 10.1200/JCO.2011.39.9782. Epub 2012 Sep 4.
PubMed 22949150
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib
- ClinicalTrials.gov ID
- NCT00300586
- Acronym / sponsor ID
- 2005.386
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer ;, metastatic ;, chemotherapy ;, erlotinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 842 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Mar 2006 (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.
The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :
- Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
- Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A (supervision) | Sham comparator | Drug: observationmedical supervision, second line chemotherapy if progression |
| B (gemcitabicine) | Active comparator | Drug: gemcitabineMaintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression |
| C (Erlotinib) | Experimental | Drug: erlotinibTreatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted.
- Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement.
- Measurable disease according to the RECIST criteria.
- Prior radiotherapy authorized except for irradiation concerning measurable disease.
- Age >18 and < 70 years.
Key exclusion criteria (16 listed)
- Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma.
- PS > 1.
- Prior chemotherapy other than cisplatin-gemcitabine.
- Prior therapy with EGFR inhibitor (e.g. monoclonal antibody).
- No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital.
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 |
|---|---|---|
| observationobservation, second line chemotherapy if progression | Drug | A (supervision) |
| gemcitabine1250 mg/m² D1, D8 q21 days | Drug | B (gemcitabicine) |
| erlotinib150 mg daily | Drug | C (Erlotinib) |
Primary outcome
Progression free survival since randomization
Time frame: time until progression
3 secondary outcomes
Overall survival,
Time frame: no time limit
toxicity (NCIC-CTC 3.0),
Time frame: time until progression
quality of life (as assessed by LCSS).
Time frame: until progression
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 28 May 2019.
- Results publication: PubMed 22949150Perol M, Chouaid C, Perol D, Barlesi F, Gervais R, Westeel V, Crequit J, Lena H, Vergnenegre A, Zalcman G, Monnet I, Le Caer H, Fournel P, Falchero L, Poudenx M, Vaylet F, Segura-Ferlay C, Devouassoux-Shisheboran M, Taron M, Milleron B. Randomized, phase III study of gemcitabine or erlotinib maintenance therapy versus observation, with predefined second-line treatment, after cisplatin-gemcitabine induction chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2012 Oct 1;30(28):3516-24. doi: 10.1200/JCO.2011.39.9782. Epub 2012 Sep 4.
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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.
Maurice Pérol, MD principal investigator
Hospices Civils de Lyon
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 observation, gemcitabine and erlotinib in people with Stage IV Non-small Cell Lung Cancer, run by Hospices Civils de Lyon 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 12 inclusion and 16 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 28 May 2019. 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. Some participants in this study may receive a placebo. 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?
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 since randomization (time frame: time until progression). 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 NCT00300586, which also lists 1 linked publication.
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 28 May 2019; AzTrials last refreshed its copy on 30 Oct 2026.