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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Erlotinib Hydrochloride; Gemcitabine

Criteria

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.