Effect of Chemotherapy on TMB in NSCLC

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