Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)
NCT ID: NCT04846634
Last Updated: 2021-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2021-08-31
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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neoadjuvant Penpulimab + chemotherapy followed by adjuvant Penpulimab
Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
A cycle of treatment is defined as 21 days of once daily treatment.
neoadjuvant Penpulimab + chemotherapy + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
A cycle of treatment is defined as 21 days of once daily treatment.
neoadjuvant Penpulimab + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Penpulimab+Anlotinib
A cycle of treatment is defined as 21 days of once daily treatment.
Interventions
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Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
A cycle of treatment is defined as 21 days of once daily treatment.
Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
A cycle of treatment is defined as 21 days of once daily treatment.
Penpulimab+Anlotinib
A cycle of treatment is defined as 21 days of once daily treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ALTER-L043
Identifier Type: -
Identifier Source: org_study_id
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