Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Patients in Arm A will receive standard full dose platinum-combination chemotherapy with or without immunotherapy, based on affordability and feasibility based on the histopathology.: P
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival Timepoint: At the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS Toxicities QoL Optimal Treatment Utility Response rate Chemotherapy-induced cognitive impairment PK PD Timepoint: PFS At progression Toxicities At every visit QOL at baseline and After every 3 cycles, At every follow-up visit, At end of study Optimal Treatment Utility after 3rd cycle Response rate every 2 months Chemotherapy induced cognitive impairment At baseline and every 3 cycle PK PD Cycle 1 day 1 | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital
Outcome results
None listed