Back to resultsPenpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043) (ALTER-L043)
Primary Purpose
Resectable Locally Advanced Non-small Cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
Penpulimab+Anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Resectable Locally Advanced Non-small Cell Lung Cancer
Eligibility 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.
Sites / Locations
- The First Affiliated Hospital of Nanchang University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
neoadjuvant Penpulimab + chemotherapy followed by adjuvant Penpulimab
neoadjuvant Penpulimab + chemotherapy + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
neoadjuvant Penpulimab + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Arm Description
Outcomes
Primary Outcome Measures
Major pathological response (MPR)
Secondary Outcome Measures
Objective response rate (ORR)
1 year Event-Free Survival rate
Event-Free Survival (EFS)
Overall survival (OS)
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Full Information
NCT ID
NCT04846634
First Posted
April 14, 2021
Last Updated
April 14, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04846634
Brief 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)
Acronym
ALTER-L043
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
February 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 anlotinib as neoadjuvant/adjuvant treatment in patients with resectable locally advanced non-small cell lung cancer. Eligible patients will be randomized to receive either penpulimab (200mg, iv, Q3W) plus chemotherapy (platinum based chemotherapy) or penpulimab (200mg, iv, Q3W) plus anlotinib (12mg, po, day 1-14, Q3W) or penpulimab (200mg, iv, Q3W) plus chemotherapy (platinum based chemotherapy) and anlotinib (12mg, po, day 1-14, Q3W) in a 1:1:1 ratio.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Locally Advanced Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neoadjuvant Penpulimab + chemotherapy followed by adjuvant Penpulimab
Arm Type
Experimental
Arm Title
neoadjuvant Penpulimab + chemotherapy + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Arm Type
Experimental
Arm Title
neoadjuvant Penpulimab + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
Other Intervention Name(s)
Investigational Product
Intervention Description
A cycle of treatment is defined as 21 days of once daily treatment.
Intervention Type
Drug
Intervention Name(s)
Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
Other Intervention Name(s)
Investigational Product
Intervention Description
A cycle of treatment is defined as 21 days of once daily treatment.
Intervention Type
Drug
Intervention Name(s)
Penpulimab+Anlotinib
Other Intervention Name(s)
Investigational Product
Intervention Description
A cycle of treatment is defined as 21 days of once daily treatment.
Primary Outcome Measure Information:
Title
Major pathological response (MPR)
Time Frame
About 3-6 weeks following completion of surgery.
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
Within 7 days before surgery.
Title
1 year Event-Free Survival rate
Time Frame
Up to 5 Years from randomization
Title
Event-Free Survival (EFS)
Time Frame
Up to 5 years from randomization.
Title
Overall survival (OS)
Time Frame
Up to 5 years from randomization.
Title
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Time Frame
Up to 5 Years from randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changli Wang
Phone
86-22-23340123 Ext. 6417
Email
wangchangli9@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bentong Yu
Email
yubentong@126.com
12. IPD Sharing Statement
Learn more about this trial
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)
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