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CompletedNCT00300586Updated May 28, 2019

IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer

A Phase 3 interventional study of observation and gemcitabine in Stage IV Non-small Cell Lung Cancer, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-28.

Sponsored by Hospices Civils de Lyon · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
842
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Stage IV Non-small Cell Lung Cancer

Keywords

  • Non-small cell lung cancer ;
  • metastatic ;
  • chemotherapy ;
  • erlotinib
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 842 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
842 participants (actual)

Study arms

  • Sham comparator
    A (supervision)

    medical supervision, second line chemotherapy if progression

    Drug: observation

  • Active comparator
    B (gemcitabicine)

    Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression

    Drug: gemcitabine

  • Experimental
    C (Erlotinib)

    Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression

    Drug: erlotinib

Interventions

  • Drugobservation

    observation, second line chemotherapy if progression

  • Druggemcitabine

    1250 mg/m² D1, D8 q21 days

  • Drugerlotinib

    150 mg daily

06

What researchers measure

Primary outcomes

  1. Progression free survival since randomization

    Time frame: time until progression

Secondary outcomes

  1. Overall survival,

    Time frame: no time limit

  2. toxicity (NCIC-CTC 3.0),

    Time frame: time until progression

  3. quality of life (as assessed by LCSS).

    Time frame: until progression

07

Study locations

1 site
  • Maurice PEROL
    Lyon, 69317, France
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00300586
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Mar 9, 2006
Start date
Jun 2006
Primary completion
Mar 2011
Completion
Mar 2011
Last update
May 28, 2019

Study contacts

Maurice Pérol, MD
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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