A Phase IIb/III, Randomised, Double-blind, Placebo-controlled, Multicentre, Study of CA-170 in Combination with Chemotherapy in Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer (ASIAD-3) - ASIAD-3

Aurigene Discovery Technologies Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

阶段: 2 期
状态: 招募中
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•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.

排除标准

•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)

研究者

发起方

Aurigene Discovery Technologies Limited

相似试验

招募中

2 期

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.

CTRI/2020/07/026870Aurigene Discovery Technologies Limited A Subsidiary of Dr Reddys Laboratories Limited India

招募中

1 期

A study to evaluate the safety and efficacy of cotadutide given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosison-cirrhotic non-alcoholic steatohepatitis with fibrosisMedDRA version: 24.1Level: LLTClassification code 10086370Term: NASH with fibrosisSystem Organ Class: 100000004871

EUCTR2021-005484-53-ESAstraZeneca AB1,860

进行中（未招募）

1 期

EUCTR2021-005484-53-HUAstraZeneca AB1,860

进行中（未招募）

1 期

A study to evaluate the safety and efficacy of cotadutide given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis

EUCTR2021-005484-53-DEAstraZeneca AB1,860

招募中

1 期

EUCTR2021-005484-53-ITASTRAZENECA AB1,860