Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: CA-170: Part 1: Combination of Chemoradiation (CTRT) with open label CA-170 (Dose escalation of CA-170)
Dose to start from 100mg BID PO on first 6 patients and depending upon the acceptable PK parameters and DLT, dose could be changed to 200mg BID PO or 100mg QD PO.
Part 2: Combination of Chemoradiatio
selected dose from Part 1 (50mg or 100mg or 200 mg BID) to be administered ORALLY
Control Intervention1: Placebo: Placebo in Combination with Chemotherapy and Radiation as Standard of care
Sponsors
Aurigene Discovery Technologies Limited A Subsidiary of Dr Reddys Laboratories Limited India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed unresectable (Stage III or IVa) Non-Squamous NSCLC 2. Newly diagnosed 3. Eligible for chemo-radio therapy as SOC 4. ECOG Status:0 or 1 5. Adequate organ and bone marrow functions 6. Willing to provide written informed consent and comply with trial requirements
Exclusion criteria
Exclusion criteria: 1. Mixed small cell and non-small cell lung cancer histology 2. Squamous histology or mixed squamous / non-squamous NSCLC histology 3. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody 4. Ongoing treatment for unresectable Stage III or IVa Non-Squamous NSCLC 5. Participation in another clinical study with an investigational product during the last 3 months 6. Recent major surgery within 4 weeks 7. Active or prior documented autoimmune disease within 2 years 8. Active or prior documented inflammatory bowel disease 9. History of primary immunodeficiency 10. History of organ transplant that requires therapeutic immunosuppression 11. Stage 1, Stage 2, Stage 4b or Stage 4c NSCLC. 12. Stage 4a NSCLC patients with clinically significant malignant pleural effusion and/or pericardial effusion, as judged by PI, and therefore, not candidates for combined chemoradiation. 13. Not eligible for combined chemoradiation, for any reason 14. Non Sq NSCLC with known positive EGFR or ALK or ROS1 mutations 15. Uncontrolled inter current illness 16. Known history of active tuberculosis within past 5 years 17. Receipt of live attenuated vaccination within 30 days prior to treatment period day 1 18. History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study 19. Female patients who are pregnant, breast-feeding, or male or female patients of reproductive potential who do not agree for birth control 20. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Part 1: Safety profile as measured by AEs / SAEs / laboratory parameters graded by NCI CTCAE version 5.0 b) The recommended CA-170 dose to be combined with chemoradiation in Part 2 of the study c) Part 2: Progression Free Survival (PFS) according to RECIST 1.1 at 12 months, as determined by an independent central radiologist (ICR)Timepoint: Part 1: Safety in Combination at 7 weeks ( 49 day) Part 2: PFS at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: PK of CA-170 at pre and post chemo radiation Part 2: Time to progression and ORR by RECIST 1.1, Overall Survival data, PFS at 6,9,15,18,24,36 months and other time points, Median PFS, Time to next treatment, Safety profile as per NCI CTCAE version 5.0, Time to Deterioration of Global Health Status / Health-Related Quality of Life using Quality of Life Questionnaire (EORTC QLQC-30), Time to Deterioration of Primary Patient-Reported Outcome Symptoms using EORTC QLQ-LC13Timepoint: PK at Pre dose and Day 36 PFS at 6,9,15,18,24,36 months Overall Survival | — |
Countries
India
Contacts
Public ContactShilendra Pandey
Aurigene Discovery Technologies Limited, A Subsidiary of Dr. Reddys Laboratories Limited
Outcome results
None listed