Effect of Chemotherapy on TMB in NSCLC

B

Baodong Qin

Status

Unknown

Conditions

Chemotherapy Effect
Immunotherapy
PD-1/L1 Inhibitor
Tumor Mutation Burden

Treatments

Other: Next-Genernation Sequence

Study type

Observational

Funder types

Other

Identifiers

NCT03683407
COTMB

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

30 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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