Neoadjuvant/Adjuvant Pembrolizumab Plus Chemotherapy

Non Small Cell Lung Cancer Clinical Trial

— NeoP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05383716
• Other study ID #: ZS-2847
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2027
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Primary non-small cell lung cancer (NSCLC) confirmed by cytology or histology

2. 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;

3. 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)

4. ECOG PS 0 or 1

5. Adequate tumor samples available for gene detection (EGFR/ALK /ros1) with non-squamous and specimens for PD-L1 immunohistochemistry (IHC) in all the subjects.

6. Male or female, = 18 years old

7. Adequate blood function: absolute neutrophil count (ANC) = 2 × 109 / L, platelet count = 100 × 109 / L and hemoglobin 110 = 9 g / dl

8. 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)

9. Adequate renal function: serum creatinine = upper limit of normal value (ULN) or calculated creatinine clearance = 60ml / min

10. No history of using anti-tumor drug treatment before

11. For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of study treatment, and the patients have recovered

12. Sign the informed consent form (the informed consent form needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure)

Exclusion Criteria:

1. Carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or other known targetable driver mutations.

2. Active, known or suspected autoimmune disease.

3. 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).

4. 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

5. History of allergy to study drug components excipients

6. 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

7. Women in pregnancy or lactation

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Immune Checkpoint Inhibitor
• Neoadjuvant Therapy
• Non Small Cell Lung Cancer

Intervention

Drug:
• Pembrolizumab
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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPR(major pathologic response)	more than 90 percent decrease in viable tumor	Up to 8weeks
Secondary	Complete pathological (CPR) response rate	The investigator assessed CPR rate was defined as the percentage of subjects who achieved complete pathological remission (no residual tumor in lung and lymph nodes)	8 weeks
Secondary	EFS (event free survival)	the time length from randomization (mainly from the receipt of pathology and genetic diagnosis reports)to any of the following events: disease progression, disease recurrence or death from any cause. Disease progression or relapse will be assessed according to RECIST 1.1	8 weeks
Secondary	OS (overall survival)	the time length from randomization (mainly from the receipt of pathology and genetic diagnosis reports)to death from any cause.	8 weeks
Secondary	Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Evaluate adverse events of any cause, treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0	8 weeks
Secondary	Evaluate tissue biomarkers	The goals for these analyses are for hypothesis generating. The results will need to be confirmed by future studies.; Used for hypothesis generating. Transcriptome analysis identity markers with efficacy and/or toxicity.	8 weeks