Effect of Chemotherapy on TMB in NSCLC

Last updated: September 23, 2018
Sponsor: Baodong Qin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer Treatment

Cancer

Vaccines

Treatment

N/A

Clinical Study ID

NCT03683407
COTMB
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofnormal (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

Exclusion Criteria:

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

  • Patient will receive immunotherapy;

Study Design

Total Participants: 30
Study Start date:
September 01, 2018
Estimated Completion Date:
August 31, 2019

Connect with a study center

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai 200003
    China

    Active - Recruiting

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