Application of Pablizumab Combined With Apatinib and Chemotherapy in Resectable Non-small Cell Lung Cancer： A Prospective, Single Arm, Single Center Phase II Clinical Study of Neoadjuvant Therapy

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04968002
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a prospective, single arm, single center clinical study to determine the efficacy and safety of pablizumab combined with apatinib and neoadjuvant chemotherapy in patients with stage iia-iiia non-small cell lung cancer. No EGFR mutation or ALK gene translocation was found in the untreated patients with NSCLC stage IIa-IIIb diagnosed by imaging, histopathology or cytology. After informed consent is signed by the patients. The patients were treated according to the protocols. The patients were followed up from adjuvant treatment and follow-up to relapse free survival until disease progression, withdrawal of informed consent, loss of follow-up or death.

Key Dates

Start date
Aug 1, 2021
Status verified
Jun 2021
Primary completion
Aug 1, 2022
Completion
Oct 1, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Preoperative neoadjuvant therapy for patients with stage IIa-IIIa non-small cell lung cancer.
    No EGFR mutation or ALK gene translocation was found in the untreated patients with NSCLC stage IIa-IIIb diagnosed by imaging, histopathology or cytology. After informed consent is signed by the patients. The patients were treated according to the protocols.

Primary Outcome Measure

The main pathological response rate [ Time Frame: through surgical treatment completion, an average of 4 months ]

Central Contacts

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