Penpulimab-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)

April 14, 2021 updated by: Tianjin Medical University Cancer Institute and Hospital
This is a multicenter, randomized, open label, phase II study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital Of NanChang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neoadjuvant Penpulimab + chemotherapy followed by adjuvant Penpulimab
Drug: Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
A cycle of treatment is defined as 21 days of once daily treatment.
Other Names:
  • Investigational Product
Experimental: neoadjuvant Penpulimab + chemotherapy + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Drug: Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
A cycle of treatment is defined as 21 days of once daily treatment.
Other Names:
  • Investigational Product
Experimental: neoadjuvant Penpulimab + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Drug: Penpulimab+Anlotinib
A cycle of treatment is defined as 21 days of once daily treatment.
Other Names:
  • Investigational Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major pathological response (MPR)
Time Frame: About 3-6 weeks following completion of surgery.
About 3-6 weeks following completion of surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: Within 7 days before surgery.
Within 7 days before surgery.
1 year Event-Free Survival rate
Time Frame: Up to 5 Years from randomization
Up to 5 Years from randomization
Event-Free Survival (EFS)
Time Frame: Up to 5 years from randomization.
Up to 5 years from randomization.
Overall survival (OS)
Time Frame: Up to 5 years from randomization.
Up to 5 years from randomization.
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Time Frame: Up to 5 Years from randomization
Up to 5 Years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

February 1, 2028

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTER-L043

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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