Resectable Locally Advanced Non-small Cell Lung Cancer Clinical Trial
— ALTER-L043Official title:
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)
This is a multicenter, randomized, open label, phase II study.
| Status | Not yet recruiting |
| Enrollment | 90 |
| Est. completion date | February 2028 |
| Est. primary completion date | March 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
| Lead Sponsor | Collaborator |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Major pathological response (MPR) | About 3-6 weeks following completion of surgery. | ||
| Secondary | Objective response rate (ORR) | Within 7 days before surgery. | ||
| Secondary | 1 year Event-Free Survival rate | Up to 5 Years from randomization | ||
| Secondary | Event-Free Survival (EFS) | Up to 5 years from randomization. | ||
| Secondary | Overall survival (OS) | Up to 5 years from randomization. | ||
| Secondary | Incidence of adverse events (AEs)/serious adverse events (SAEs) | Up to 5 Years from randomization |