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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


Phase 3
18 Years
70 Years
Not Enrolling
Both
Stage IV Non-small Cell Lung Cancer

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Trial Information

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


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:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival since randomization

Outcome Time Frame:

time until progression

Safety Issue:

No

Principal Investigator

Maurice Pérol, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2005.386

NCT ID:

NCT00300586

Start Date:

June 2006

Completion Date:

March 2011

Related Keywords:

  • Stage IV Non-Small Cell Lung Cancer
  • Non-small cell lung cancer ;
  • metastatic ;
  • chemotherapy ;
  • erlotinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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