Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Reduced-dose Lorlatinib.: Lorlatinib 25 mg orally
daily.Total duration will be till progression or intolerable toxicity.
PATIENT EVALUATION
-Initially every week for 1st 2 weeks
-Subseq
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed non-small cell lung carcinoma with ALK alteration, Planned for palliative intent (noncurative) systemic therapy, Patients who are treatment-na ve (planned for first line palliative intent systemic therapy); Patients who cannot afford full dose ALK-directed TKI therapy; Patients who have received one or more cycles of chemotherapy while awaiting the results of molecular testing, i.e., before the results of the ALK testing are available are eligible for this study. -Adequate renal, liver, cardiac and bone marrow function -ECOG performance status (PS) of 0 to 2
Exclusion criteria
Exclusion criteria: Known severe hypersensitivity to crizotinib or lorlatinib or any of the excipients of these products; as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease); gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer disease in the past 6 months; malabsorption syndromes; evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study; Pregnancy or breast feeding; concurrent use of known strong CYP3A inhibitors, known strong CYP3A inducers, or CYP3A substrates with narrow therapeutic indices, known P-gp substrates with a narrow therapeutic index; treatment with a non-approved or investigational drug within 30 days before the first day of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival Timepoint: Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate response ratesTimepoint: Objective Response Rate to Evaluated every 8 weeks with radiologic assessments via CT scans.;overall survivalTimepoint: Overall Survival OS Tracked continuously from randomization until death from any cause. ;ToxicitiesTimepoint: Toxicity Assessed at every visit using CTCAE version 5. Evaluations occur Weekly for the first 2 weeks & Every 8 weeks thereafter.;QOL (EORTC Q30 & LC13)Timepoint: Quality of Life (QOL) is Evaluated using the EORTC QLQ-C30 & LC13 questionnaires:- At baseline, Every 8 weeks.;Time to tumor responseTimepoint: Time to Tumor Response is Evaluated continuously from randomization to the first documented tumor response | — |
Countries
India
Contacts
Public ContactDr Srushti Shah
Tata Memorial Centre
Outcome results
None listed