Clinical trial · Observational
Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)
A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following by/ Gemcitabine When Progression.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 65 years * Comorbidities score, * PS frailty score\*\*.according to(TABLE N°1) * No dementia, repeated falls, faecal or urinary incontinence, ADL=0, IADL=0 * Life expectancy at least 12 weeks * Créatinine clearance de la créatinine \> or =30cc/mn according to Cockrofts * Gault formula * Competency to give written informed consent * Haematological function as follows: absolute neutrophil count \> 1.5 x 109/l and/or platelet\> 100 x 109/l, hémoglobine \> or = 9,5 g/dl * Hepatic function as followed :bilirubin \<1,25 LNS SGOT/SGPT \<5 x N,PAL \<5N * PS \< 3 * No symptomatic cerebral metastasis * Histologically or cytologically confirmed NSCLC * Stage IV/IIIB4 (T4with pleural effusion) * No prior chemotherapy for NSCLC * Relapses of previous NSCLC treated by surgery or radiotherapy are eligible if the target is measurable out of initial radiotherapy field and if histological or cytological proof * At least one measurable target lesion by RECIST guidelines. Exclusion Criteria: * Symptomatic cerebral metastasis * Any severe co-morbidity calculated by Charlson score (according to table 1), any kind of disorder that compromises the ability of the subject to give written informed and/or comply with the study procedure ADL \> or = 1 et IADL \> or =1 Dementia, repeated falls, faecal or urinary incontinence- Peripheral neuropathy grade 2 or more * Performance Status \> 2 ( ECOG)- Contraindication to corticosteroids * Unwilling or unable to comply with study requirements for personal , family, sociologic, geographic or any reasons * Lack of liberty following administrative or judicial decision * Hypersensitivity to polysorbate * Hypersensitivity to erlotinib or any excipients of this product * Unusual hereditary disorders as galactosemia, deficit in lactase and malabsorption in glucose or galactose * Participation in concomitant clinical trial * Contraindication to a product of this study disease * Bronchioloalvéolar or neuroendocrine or composite carcinoma * Superior vena cava syndrome
References
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