Health Condition 1: null- Advanced Carcinoma Lung Patients taking either pemetrexed or Erlotinib.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. TKI-naive patients with documented Stage III OR Stage IV NSCLC who experience stable disease/ partial response/ complete response after 4-6 cycles of Pemetrexed + Cisplatin/Carboplatin chemotherapy. 2. ECOG Performance status (PS) from 0 to 2 3. Age >= 18yrs 4. Adequate bone marrowtests (absolute neutrophil count >1500/lL, hemoglobin > 8 g/dL, and platelet count >100,000/lL), renalfunction tests (creatinine 5. Life expectancy >= 3 months 6. Clinically stablebrain metastases if any
Exclusion criteria
Exclusion criteria: 1. Prior therapy with TKI 2. Squamous cell Histology 3. A second primary tumor 4. Uncontrolled infection 5. Uncontrolled co-morbidities Premenopausal women will be required to practice a suitable method of birth control and have a negative pregnancy test.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and Toxicity of these two regimens 2. PFS and OS in these two regimens Timepoint: Safety & toxicity at every Follow Up visit PFS & OS at every regular F/U | — |
Primary
| Measure | Time frame |
|---|---|
| Study the QOL in these two regimes at 3 monthsTimepoint: At every 3 months | — |
Countries
India
Contacts
Tata Memorial Hospital