Status:
NOT_YET_RECRUITING
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Resectable Locally Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, open label, phase II study.
Detailed Description
This is a multicenter, randomized, open label, phase II study assessing the efficacy and safety of penpulimab plus chemotherapy or penpulimab plus anlotinib or penpulimab plus chemotherapy and anlotin...
Eligibility Criteria
Inclusion
- Early stage IIB-IIIB (N2), operable non-small cell lung cancer, confirmed in tissue.
- Epidermal growth factor receptor/anaplastic lymphoma kinase/ROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
- Lung function capacity capable of tolerating the proposed lung surgery.
- Patients had never received surgery, chemotherapy, radiotherapy or biotherapy.
Exclusion
- Large cell carcinoma and mixed cell lung cancer.
- Any systemic anti-cancer treatment for NSCLC, including cytotoxic drug therapy, immunotherapy, experimental treatment.
- Prior treatment with local radiotherapy.
- Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).
- Prior treatment with antilotinib and other antiangiogenic drugs.
- History of hypersensitivity to any active or inactive ingredient of Penpulimab, Anlotinib or chemotherapy.
- Patients with multiple factors affecting oral medication (e.g. inability to swallow, chronic diarrhea, and intestinal obstruction, etc.).
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Patients whose tumor has invaded important blood vessels or whose tumor is likely to invade important blood vessels and cause fatal massive hemorrhage during follow-up study.
- Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism.
- Pregnant or lactating women.
- History of neurological or mental disorders, including epilepsy or dementia.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04846634
Start Date
August 1 2021
End Date
February 1 2028
Last Update
April 15 2021
Active Locations (1)
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1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China