CTRI/2022/07/044193
Not yet recruiting
Phase 3
Optimizing chemotherapy in the first line for frail older patients with advanced non-small cell lung cancer.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
- Sponsor
- Tata Memorial Hospital
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \= 60 years
- •2\. Histologically or cytologically confirmed non\-small cell lung carcinoma (NSCLC).
- •3\. Absence of sensitizing EGFR mutation and absence of EML4\-ALK fusion. Patient is not planned for molecular targeted therapy, including EGFR\-directed oral tyrosine kinase inhibitor or ALK\-directed oral tyrosine kinase inhibitor. Patients with molecularly driven NSCLC who cannot receive molecularly targeted therapy for any reason and who are planned for first\-line palliative intent chemotherapy will be eligible for the trial.
- •4\. Planned for palliative intent chemotherapy in the first line.
- •5\. ECOG PS 0 to 2 (on a 6\-point scale ranging from 0 to 5, with higher scores indicating increasing disability; a score of 0 indicates no symptoms, 1 indicates mild symptoms and restricted in physically strenuous activities but ambulatory and able to do light work; and 2 indicates that the patient is ambulatory and capable of all selfcare but unable to do any work, and is up and about over half of the waking hours)
Exclusion Criteria
- •1\. Known severe hypersensitivity to platinum, pemetrexed or any of the excipients of these products or pre\-medications.
- •2\. Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) as judged by the investigator
- •3\. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
- •4\. Inadequate organ function.
Outcomes
Primary Outcomes
Not specified
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