A Phase IIb/III clinical trial to assess the safety and efficacy of study drug, CA-170 in combination with standard chemotherapy in stage IV lung cancer patients.

Phase 2

• Conditions: Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified

• Registration Number: CTRI/2021/10/037699
• Lead Sponsor: Aurigene Discovery Technologies Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female patients aged 18 years or older. 2. Histologically documented, treatment-naïve Stage IV NonSquamous NSCLC (Version 8 of the International Association for the Study of Lung Cancer (IASLC) Staging Manual in Thoracic Oncology (Appendix E)). 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix F) 4. Ability to swallow and retain oral medications. 5. Evidence of measurable disease per RECIST, v1.1 as defined as lesion that can be accurately measured in at least 1 dimension with minimum size of 10 mm. 6. Adequate organ and marrow function as defined below: • Absolute neutrophil count (ANC) =1.5 x 109/L (1500 per mm3) • Platelets =100 x 109/L (100,000 per mm3) • Haemoglobin (Hb) =9.0 g/dL (5.59 mmol/L). (Patients can be transfused to bring Hb to this level). • Serum creatinine = 2.0 mg/dL • LFT: = 3 X of ULN for ALT, AST and = 2 X of ULN Total Bilirubin 7. Patients willing and able to provide written informed consent and comply with the requirements of the trial.

Exclusion Criteria

1. Squamous NSCLC histology 2. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody 3. Previous or ongoing treatment (any chemotherapy, therapeutic radiotherapy, or immunotherapy) for Non-Squamous NSCLC Note: Palliative radiotherapy is allowed 4. Participation in another clinical study with an investigational product during the last 3 months 5. Recent major surgery (excluding the placement of vascular access) within 4 weeks (28 days) prior to Day 1 of Cycle 1. (Major surgery is defined as any surgical procedure (other than placement of vascular access device) requiring general anaesthesia) 6. Active or prior documented autoimmune disease requiring the use of systemic immunosuppressive medications ( > 10 mg/day of prednisone or equivalent) or other immunomodulator drugs. (Note: Patients with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment are not excluded. In addition, patients with hypothyroidism on thyroid replacement therapy are not excluded)

7. Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, Ulcerative colitis, etc.) 8. History of primary immunodeficiency 9. History of organ transplant that requires therapeutic immunosuppression. 10. Known symptomatic or untreated or recently treated (= 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated ( > 6 months of screening) CNS metastases who are now stable and asymptomatic are allowed 11. Not eligible for carboplatin and/or pemetrexed, for any reason 12. NSCLC with positive driver mutations, such as Epidermal growth factor receptor (EGFR) mutation or Anaplastic lymphoma kinase (ALK mutation) (Note: Patients who have been tested for driver mutations prior to screening, do not need to be re-tested during screening and available results should be used to determined eligibility per this exclusion criterion 12. Patients not tested for driver mutation prior to screening should be tested during screening). 13. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study. 15. Known history of active tuberculosis within past 5 years. 16. Receipt of live attenuated vaccination within 30 days prior to treatment period day 1 of Cycle 1 17. Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 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. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or randomisation visit 20. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap)

Study & Design

• Study Type: Interventional
• Study Design: Not specified