A study to compare survival with Oral TKI against Oral TKI and intravenous chemotherapy in advanced lung cancer patients
- Conditions
- Health Condition 1: null- Patients who have EGFR mutation positive Non small Cell lung cancer
- Registration Number
- CTRI/2016/08/007149
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 350
•Histologically or cytologically confirmed non-small cell lung carcinoma with EGFR mutation positive for exon 19, 21 or 18
•Locally advanced stage IIIB not amenable to local therapy (eg. Pleural effusion) or stage IV (metastatic) disease.
•No prior palliative chemotherapy, or palliative biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VGEF) inhibitors) or immunological therapy.
Previous adjuvant chemotherapy is permitted if treatment was not platinum-based and was completed more than 6 months before day 1. Palliative radiotherapy to a metastatic site is permitted, but palliative wide field radiotherapy to the lung must be completed at least 4 weeks before day 1 with no persistence of any radiotherapy-related toxicity.
•Measurable disease according to RECIST criteria with at least one measurable lesion not previously irradiated
•WHO performance status (PS) of 0 to 2
•Patients must be willing to complete EORTC QOL.
•Known severe hypersensitivity to gefitinib or any of the excipients of this product
•Known severe hypersensitivity to Platinum, Pemetrexed or any of the excipients of these products
•Known severe hypersensitivity to pre-medications required for treatment with Platinum / Pemetrexed doublet chemotherapy
•History or presence of any other malignancy with the exception of basal cell carcinoma or cervical cancer in situ
•Past medical history of interstitial lung disease, drug induced interstitial disease,radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.
•Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline
•Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
•As judged by the investigator, any evidence of severe or uncontrolled systemic disease ( e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
•Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
•Adequate organ function, including the following:
i)Adequate bone marrow reserve: absolute neutrophil (segmented and bands) counts (ANC) >= 1.5X109/L, Platelets >=100X109/L
ii)Hepatic: bilirubin <= 1.5 times the upper limit of normal(xULN), Alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <= 3.0 times the ULN if no demonstrable liver metastases (AST,ALT <= 5 XULN is acceptable if liver has tumor involvement).Serum Creatinine <= 1.5 times the ULN or Creatitne Clearance >= 60 ml/min.
•Pregnancy or breast feeding
•Unable to tolerate Platinum / Pemetrexed doublet chemotherapy, as judged by the investigator.
•Life expectancy of <= 12 weeks
•Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates
•Treatment with a non-approved or investigational drug within 30 days before Day of study treatment
•Involvement in the planning and conduct of the study
•Previous enrollment or randomization of treatment in the present study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survivalTimepoint: <br/ ><br>From date of randomization until the date of disease progression is documented or death from any cause
- Secondary Outcome Measures
Name Time Method 1.Overall Survival <br/ ><br>2.Side effects <br/ ><br>3.Response rate <br/ ><br>4.Quality of lifeTimepoint: 1.Overall survival from randomization until date of death <br/ ><br>2.Side effects at each visit <br/ ><br>3.Response rate at every six months <br/ ><br>4.Quality of life at every planned visit