Status:
UNKNOWN
Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Metastatic NSCLC
Recurrent NSCLC
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a single-arm, prospective, exploratory clinical study aiming to evaluate the efficacy and safety profile of sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent ...
Detailed Description
Sintilimab (200 mg intravenously, once every 3 weeks; Cinda Bio-Suzhou Co., Ltd., Suzhou, Jiangsu, China) and anlotinib hydrochloride (12 mg orally, once daily before breakfast; CTTQ, Lianyungang, Jia...
Eligibility Criteria
Inclusion
- 1\. Voluntary provision of informed consent.
- 2\. Males or females aged 18-75.
- 3\. Histological or cytologically confirmed NSCLC, metastatic or recurrent (stage IV), non-resectable or radical radio-chemotherapy locally advanced (stage IIIB-IIIC).
- 4\. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, or ROS1 gene mutation)
- 5\. At least one lesion can be measured by imaging.
- 6\. Have not received systemic treatment in the past.
- 7\. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- 8\. Life expectancy ≥ 3 months.
- 9\. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.
Exclusion
- 1\. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
- 2\. Received radiation therapy within 6 weeks.
- 3\. Diagnosed with other malignant diseases other than NSCLC within 5 years.
- 4\. Have participated in other interventional clinical research treatments now or within 4 weeks.
- 5\. Have previously received targeted therapy.
- 6\. Received Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs within 2 weeks.
- 7\. Have active autoimmune diseases requiring systemic treatment within 2 years.
- 8\. Received systemic glucocorticoid therapy or immunosuppressive therapy within 7 days.
- 9\. Clinically uncontrollable pleural effusion/abdominal effusion.
- 10\. Known allogeneic organ transplantation or hematopoietic stem cell transplantation.
- 11\. Known to be allergic to study drug.
- 12\. Have been vaccinated with the live vaccine within 30 days.
- 13\. Pregnant or breastfeeding females.
- 14\. Other serious hazards to the safety of patients.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04846452
Start Date
June 1 2021
End Date
May 1 2023
Last Update
August 12 2021
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029