A double-blind and placebo controlled clinical study conducted on patients with stage III or IVa Non-Small Cell Lung Cancer of investigational drug, CA170 in combination with Chemotherapy and Radiation Therapy at several clinical sites across India.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2020/07/026870
- Lead Sponsor
- Aurigene Discovery Technologies Limited A Subsidiary of Dr Reddys Laboratories Limited India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method