Effect of Chemotherapy on TMB in NSCLC

• Conditions: Chemotherapy Effect; Immunotherapy; Tumor Mutation Burden; PD-1/L1 Inhibitor
• Interventions: Other: Next-Genernation Sequence

• Registration Number: NCT03683407
• Lead Sponsor: Baodong Qin

Brief Summary

Tumor mutation burden is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect tumor mutation burden in advanced NSCLC patients. The present study aims to evaluate whether tumor mutation burden will change after receiving chemotherapy in advanced NSCLC patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-01
• Study First Submitted: 2018-09-16
• Study First Submitted QC: 2018-09-23
• Last Update Submitted: 2018-09-23
• Study First Posted: 2018-09-25
• Last Update Posted: 2018-09-25
• Primary Completion: 2019-02-28
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
• Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
• ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria

• Patient can not comply with research program requirements or follow-up;
• Patient will receive immunotherapy;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy Group	Next-Genernation Sequence	All participants are advanced NSCLC without druggable gene mutation (EGFR, ALK, ROS-1, Met, Ret. BRAF, etc), who would receive platinum-based chemotherapy.

Primary Outcome Measures

Name	Time	Method
Tumor Mutation Burden Change	every 6 weeks up to progression disease	Tumor mutation burden will be calculated using a 520 genes NGS panel

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China