Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Tyrosine kinase inhibitor: Physician choice TKI. In this arm an appropriate TKI based on international and national guidelines would be administered. The recommended TKI are given below
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have leptomeningeal metastasis from a driver mutated NSCLC. The diagnosis of LMM will be based on EANO criteria16. Patients with either confirmed or probable LMM disease status will be included in this study 2. Age: Male or female subjects aged = 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3. 4. Subjects must have normal organ and marrow function as per TMH 5. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active antiretroviral therapy), and have absence of active AIDS defining conditions. 6. Both men and women of all races and ethnic groups are eligible for this study. 7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments. 8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Subjects who are receiving any other investigational agents. 2. Within 2 weeks of administration of a chemotherapeutic agent. 3. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis. 4. Active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. 5. Prior organ transplantation including allogeneic stem-cell transplantation. 6. Active infection requiring systemic therapy. 7. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v4.03 Grade = 3). 8. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke ( 9. Pregnant and lactating women are excluded from this study. 10. Local site infection making it infeasible for lumbar puncture 11. Persistent features of raised intracranial pressure which has not subsided post steroids, mannitol and other decongesting interventions thus ruling out option of lumbar puncture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) Timepoint: from first administration of study drug until 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression Free Survival (PFS) 2.Progression Free Survival (PFS)-LM 3.Adverse Events (AEs) 4.Quality of Life analysisTimepoint: 1. from date of randomization until first observation of disease progression or clinical progression occurrence of death 2.from date of randomization until first observation of disease progression (cranial with RANO criteria ) or clinical cranial progression occurrence of death 3. From the first dose of study drug treatment up to 30 days after the last dose of study drug administration 4.At baseline, 2, 4 and 6 months | — |
Countries
India
Contacts
Public ContactDr Devanshee Shah
Tata Memorial Center
Outcome results
None listed