Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)

• Status: Not yet recruiting
• Trial end date: 2028-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, open label, phase II study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborator: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Docetaxel; Gemcitabine; Paclitaxel; Pemetrexed

Criteria

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.