A Single-arm Exploratory Study of Neoadjuvant Therapy

Not Applicable

Recruiting

• Conditions: Lung Adenocarcinoma
• Interventions: Drug: Tislelizumab; Drug: pemetrexed; Drug: cis-platemum; Drug: or carboplatin

• Registration Number: NCT05527808
• Lead Sponsor: Jun Liu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-06
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. 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;
2. Age 18-75 (boundary value included), no gender limitation;
3. Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American Joint Commission on Cancer, 8th Edition);
4. EGFR gene mutation positive (can be tested by tissue or blood samples);
5. PD-L1 ≥ 1%
6. ECOG PS score 0-1 (including boundary value);
7. Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed;
8. Meet the conditions for receiving platinum containing two-drug chemotherapy;
9. The expected survival time is ≥3 months, and feasible surgery is planned;

Exclusion Criteria

1. Any previous treatment for current lung cancer, including systemic therapy or radiotherapy;
2. there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV).
3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant ICI combined with chemotherory	cis-platemum	intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
Neoadjuvant ICI combined with chemotherory	or carboplatin	intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
Neoadjuvant ICI combined with chemotherory	Tislelizumab	intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
Neoadjuvant ICI combined with chemotherory	pemetrexed	intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles

Primary Outcome Measures

Name	Time	Method
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）	15-18 weeks after enrollment	MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated

Secondary Outcome Measures

Name	Time	Method
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	6-12weeks after enrollment	To evaluate objective response rate (ORR) in neoadjuvant treatment
pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes	15-18 weeks after enrollment	pCR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated
Descending rate of lymph nodes	15-18 weeks after enrollment	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	through study completion, an average of 35weeks	To evaluate the safety profile(Number of Participants with Adverse Events)
The time of surgery delay	4-6weeks after completation of the last neoadjuvant therapy	evaluate the interval time from the completation of last neoadjuvant therapy to surgery
minimally invasive surgery rate	4-6weeks after completation of the last neoadjuvant therapy	explore different surgery manner rate after neoadjuvant

Trial Locations

Locations (1)

First Affiliated Hospital, Guangzhou Medical University; 🇨🇳 Guangzhou, Please Select, China