CTRI/2016/08/007149
Not yet recruiting
未知
A randomized study to compare gefitinib vs chemotherapy with gefitinib in EGFR mutation positive Non-Small cell lung cancer in palliative setting.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients who have EGFR mutation positive Non small Cell lung cancer
- Sponsor
- Tata Memorial Centre
- Enrollment
- 350
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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:
Outcomes
Primary Outcomes
Not specified
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