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A Single-arm Exploratory Study of Neoadjuvant Therapy

Primary Purpose

Lung Adenocarcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Tislelizumab

pemetrexed

cis-platemum

or carboplatin

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma focused on measuring Resectable II-IIIB, EGFR mutation and PD-L1≥1%, NSCLC, Neoadjuvant immunotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Volunteer to participate in clinical research;Fully understand and be Informed of the study and sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures;
Age 18-75 (boundary value included), no gender limitation;
Histologically proven stage II-IIIA non-squamous non-small cell lung cancer (as defined by the American Joint Commission on Cancer, 8th Edition);
EGFR gene mutation positive (can be tested by tissue or blood samples);
Pd-l1 expression is greater than or equal to 50% (Detect PD-L1 expression antibody clone no: Ventana SP263)
ECOG PS score 0-1 (including boundary value);
Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed;
Meet the conditions for receiving platinum containing two-drug chemotherapy;
The expected survival time is ≥3 months, and feasible surgery is planned;

Exclusion Criteria:

Any previous treatment for current lung cancer, including systemic therapy or radiotherapy;
there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV).In patients with mediastinal lymph node involvement assessed by PET/CT, mediastinal lymph node samples from zones 4 (bilateral) and 7 should be collected to determine clinical staging to rule out stage IIIB disease.
A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.Patients with any severe and/or uncontrolled disease or symptom

Sites / Locations

First Affiliated Hospital, Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant ICI combined with chemotherory

Arm Description

intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles

Outcomes

Primary Outcome Measures

Major pathologic response rate (MPR) （proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes）

MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated

Secondary Outcome Measures

ORR: Proportion of patients who achieved complete response (CR) or partial response (PR) among all randomized patients with measurable disease at baseline assessed according to RECIST version 1.1

To evaluate objective response rate (ORR) in neoadjuvant treatment

pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes

pCR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated

Descending rate of lymph nodes

Proportion of patients whose pathologic lymph node stage was reduced to N1/N0 by baseline radiographic assessment of N2 or N1

Number of Participants with Adverse Events

To evaluate the safety profile(Number of Participants with Adverse Events)

The time of surgery delay

evaluate the interval time from the completation of last neoadjuvant therapy to surgery

minimally invasive surgery rate

explore different surgery manner rate after neoadjuvant

Full Information

NCT ID

NCT05527808

First Posted

August 3, 2022

Last Updated

June 6, 2023

Sponsor

Jun Liu

1. Study Identification

Unique Protocol Identification Number

NCT05527808

Brief Title

A Single-arm Exploratory Study of Neoadjuvant Therapy

Official Title

Neoadjuvant Tislelizumab and Platinum-Based Doublet Chemotherapy in Stage II-IIIB EGFR-Mutated Lung Adenocarcinoma With PD-L1 Positive Expression -- A Phase II Study (DuoVitality)"

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jun Liu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Adenocarcinoma

Keywords

Resectable II-IIIB, EGFR mutation and PD-L1≥1%, NSCLC, Neoadjuvant immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant ICI combined with chemotherory

Arm Type

Experimental

Arm Description

intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles

Intervention Type

Drug

Intervention Name(s)

Tislelizumab

Intervention Description

200 mg ,intravenous injection ,Q3W 2-4 cycles

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Intervention Description

500 mg/m2,intravenous injection ,Q3W 2-4 cycles

Intervention Type

Drug

Intervention Name(s)

cis-platemum

Intervention Description

60-75mg/m2 ,intravenous injection ,Q3W 2-4 cycles

Intervention Type

Drug

Intervention Name(s)

or carboplatin

Intervention Description

AUC(4-5) ,intravenous injection ,Q3W 2-4 cycles

Primary Outcome Measure Information:

Title

Major pathologic response rate (MPR) （proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes）

Description

MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated

Time Frame

15-18 weeks after enrollment

Secondary Outcome Measure Information:

Title

ORR: Proportion of patients who achieved complete response (CR) or partial response (PR) among all randomized patients with measurable disease at baseline assessed according to RECIST version 1.1

Description

To evaluate objective response rate (ORR) in neoadjuvant treatment

Time Frame

6-12weeks after enrollment

Title

pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes

Description

pCR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated

Time Frame

15-18 weeks after enrollment

Title

Descending rate of lymph nodes

Description

Proportion of patients whose pathologic lymph node stage was reduced to N1/N0 by baseline radiographic assessment of N2 or N1

Time Frame

15-18 weeks after enrollment

Title

Number of Participants with Adverse Events

Description

To evaluate the safety profile(Number of Participants with Adverse Events)

Time Frame

through study completion, an average of 35weeks

Title

The time of surgery delay

Description

evaluate the interval time from the completation of last neoadjuvant therapy to surgery

Time Frame

4-6weeks after completation of the last neoadjuvant therapy

Title

minimally invasive surgery rate

Description

explore different surgery manner rate after neoadjuvant

Time Frame

4-6weeks after completation of the last neoadjuvant therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Volunteer to participate in clinical research;Fully understand and be Informed of the study and sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures; Age 18-75 (boundary value included), no gender limitation; Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American Joint Commission on Cancer, 8th Edition); EGFR gene mutation positive (can be tested by tissue or blood samples); PD-L1 ≥ 1% ECOG PS score 0-1 (including boundary value); Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed; Meet the conditions for receiving platinum containing two-drug chemotherapy; The expected survival time is ≥3 months, and feasible surgery is planned; Exclusion Criteria: Any previous treatment for current lung cancer, including systemic therapy or radiotherapy; there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV). A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.Patients with any severe and/or uncontrolled disease or symptom

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Henry liang, Dr

Phone

15625064712

hengrui_liang@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun liu, Professor

Organizational Affiliation

1First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affiliated Hospital, Guangzhou Medical University

City

Guangzhou

State/Province

Please Select

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

hengrui liang

Phone

15625064712

hengrui_liang@163.com

First Name & Middle Initial & Last Name & Degree

jun liu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28461257

Citation

Chansky K, Detterbeck FC, Nicholson AG, Rusch VW, Vallieres E, Groome P, Kennedy C, Krasnik M, Peake M, Shemanski L, Bolejack V, Crowley JJ, Asamura H, Rami-Porta R; IASLC Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions. The IASLC Lung Cancer Staging Project: External Validation of the Revision of the TNM Stage Groupings in the Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2017 Jul;12(7):1109-1121. doi: 10.1016/j.jtho.2017.04.011. Epub 2017 Apr 28.

Results Reference

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PubMed Identifier

21789116

Citation

Wozniak AJ, Gadgeel SM. Adjuvant therapy for resected non-small cell lung cancer. Ther Adv Med Oncol. 2009 Sep;1(2):109-18. doi: 10.1177/1758834009338634.

Results Reference

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PubMed Identifier

9161793

Citation

Rosell R, Lopez-Cabrerizo MP, Astudillo J. Preoperative chemotherapy for stage IIIA non-small cell lung cancer. Curr Opin Oncol. 1997 Mar;9(2):149-55. doi: 10.1097/00001622-199703000-00008.

Results Reference

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PubMed Identifier

31194613

Citation

Zhong WZ, Chen KN, Chen C, Gu CD, Wang J, Yang XN, Mao WM, Wang Q, Qiao GB, Cheng Y, Xu L, Wang CL, Chen MW, Kang X, Yan W, Yan HH, Liao RQ, Yang JJ, Zhang XC, Zhou Q, Wu YL. Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR-Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study. J Clin Oncol. 2019 Sep 1;37(25):2235-2245. doi: 10.1200/JCO.19.00075. Epub 2019 Jun 13.

Results Reference

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PubMed Identifier

24576776

Citation

NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet. 2014 May 3;383(9928):1561-71. doi: 10.1016/S0140-6736(13)62159-5. Epub 2014 Feb 25.

Results Reference

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A Single-arm Exploratory Study of Neoadjuvant Therapy

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