A Prospective, Single-arm PhaseⅡTrial of Neoadjuvant/Adjuvant Pembrolizumab Plus Platinum-doublet Chemotherapy (Chemo) in IIa-IIIb NSCLC

Peking Union Medical College Hospital1 site in 1 country80 target enrollmentJuly 1, 2022

ConditionsNon Small Cell Lung Cancer Neoadjuvant Therapy Immune Checkpoint Inhibitor

InterventionsPembrolizumab

DrugsPembrolizumab

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Non Small Cell Lung Cancer
Sponsor: Peking Union Medical College Hospital
Enrollment: 80
Locations: 1
Primary Endpoint: MPR(major pathologic response)
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A phase II, single-arm, open-label study evaluating feasibility, safety and efficacy of combined chemotherapy and pembrolizumab as neoadjuvant/adjuvant therapy in stage IIa-IIIB NSCLC adult patients followed by adjuvant PD-(L)1 inhibitor treatment for up to 1 year

Detailed Description

Two to four cycles of neoadjuvant chemotherapy in combination with pembrolizumab will be administered before surgery, followed by another one to two cycles of chemotherapy plus pembrolizumab after surgery (4 cycles neoadjuvant/adjuvant chemotherapy in total ) then use pembrolizumab monotherapy for up to 1 year.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

December 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Principal Investigator

Wang mengzhao

Prof.

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

•Primary non-small cell lung cancer (NSCLC) confirmed by cytology or histology
•Stage IIa to selected IIIb ( t1-4, n0-2 ) NSCLC according to the TNM stage (8th Edition) of IASLC, which is considered to be resectable;
•At least one evaluable focus judged according to RECIST 1.1 standard (on spiral CT, the longest diameter of tumor should be at least 10 mm, the shortest diameter of metastasis lymphnode should be at least 20 mm)
•ECOG PS 0 or 1
•Adequate tumor samples available for gene detection (EGFR/ALK /ros1) with non-squamous and specimens for PD-L1 immunohistochemistry (IHC) in all the subjects.
•Male or female, ≥ 18 years old
•Adequate blood function: absolute neutrophil count (ANC) ≥ 2 × 109 / L, platelet count ≥ 100 × 109 / L and hemoglobin 110 ≥ 9 g / dl
•Adequate liver function: total bilirubin ≤ upper limit of normal value (ULN); AST and alt ≤ upper limit of normal value (ULN); alkaline phosphatase ≤ upper limit of normal value (ULN)
•Adequate renal function: serum creatinine ≤ upper limit of normal value (ULN) or calculated creatinine clearance ≥ 60ml / min
•No history of using anti-tumor drug treatment before

Exclusion Criteria

•Carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or other known targetable driver mutations.
•Active, known or suspected autoimmune disease.
•Other active malignancy in the last 5 years (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast).
•Prior treatment with anti-PD-1, anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen (CTLA-4), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
•History of allergy to study drug components excipients
•Having any uncontrolled systemic diseases, including active infection, uncontrolled hypertension, diabetes, unstable angina, congestive heart failure, acte myocardial infarction (within 3 months before treatment), serious arrhythmia requiring drug treatment, liver, kidney and metabolic diseases
•Women in pregnancy or lactation

Arms & Interventions

chemotherapy plus pembrolizumab

Intervention: Pembrolizumab

Outcomes

Primary Outcomes

MPR(major pathologic response)

Time Frame: Up to 8weeks

more than 90 percent decrease in viable tumor

Secondary Outcomes

EFS (event free survival)(8 weeks)
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0(8 weeks)
Complete pathological (CPR) response rate(8 weeks)
OS (overall survival)(8 weeks)
Evaluate tissue biomarkers(8 weeks)