Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Nivolumab 20 mg + Low dose chemotherapy (Paclitaxel and Carboplatin): Low-dose nivolumab (20 mg IV every 3 weeks) plus low-dose
chemotherapy (i.e. paclitaxel 60 mg/m2 IV weekly for firs
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 to 65 years 2. Histologically or cytologically confirmed NSCLC 3. Stage 4 or stage 3B or 3C as per AJCC 8th edition which is not amenable for curative intent treatment 4. ECOG performance status of 2 or more 5. Charlson comorbidity score of less than 9 with any comorbidity well under control 6. Measurable disease per RECIST v1.1 7. Adequate organ function: a. eGFR of greater than 30ml per min, b. LFT with Bilirubin less than two times ULN and transaminases less than three times ULN c. Adequate bone marrow function i Hb greater than 8gm/dl ii Platelet greater than 1,00,000 per mm3 iii ANC greater than 1500 per mm3 8. Serum albumin 3.5 gm per dl 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1 Active malignancy other than NSCLC currently or in the past 5 years 2 Lactating and pregnant women 3 HIV positive patients, hepatitis B positive patients and HCV positive patients 4 Driver mutation-positive: EGFR, ALK and ROS1 5 Symptomatic, untreated brain metastasis. 6 Asymptomatic incidentally detected brain metastasis and treated brain metastasis will not be excluded provided not requiring steroids. 7 Prior treatment with an anti PD-1, anti PD-L1, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 8 Active, known, or suspected autoimmune disease (except type I diabetes mellitus, hypothyroidism, skin disorders such as vitiligo, psoriasis, or alopecia not requiring systemic treatment, and conditions not expected to recur in the absence of an external trigger) 9 Use of corticosteroids (10 mg daily of prednisone equivalent) or other immunosuppressive medications within 14 days of treatment assignment 10 Evidence of interstitial lung disease which is symptomatic and whose clinical presentation/management may interfere with the detection and/or treatment of pulmonary toxicity due to immunotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival (PFS) rateTimepoint: 6 month after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate (ORR), overall survival (OS), quality of life (QoL), toxicities as per CTCAE v 5Timepoint: At Week-0 & 6, 03 months, 06 months during the entire study period | — |
Countries
India
Contacts
Public ContactDR Prabhat Singh Malik
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
Outcome results
None listed