Effect of Chemotherapy on TMB in NSCLC

Sponsor

Baodong Qin (Other)

Overall Status

Unknown status

CT.gov ID

NCT03683407

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy Effect Immunotherapy Tumor Mutation Burden PD-1/L1 Inhibitor	Other: Next-Genernation Sequence

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect of Platinum-based Chemotherapy on Tumor Mutation Burden in Patients With Advanced Non-small Cell Lung Cancer

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Feb 28, 2019

Anticipated Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Chemotherapy Group All participants are advanced NSCLC without druggable gene mutation (EGFR, ALK, ROS-1, Met, Ret. BRAF, etc), who would receive platinum-based chemotherapy.	Other: Next-Genernation Sequence Tumor Mutation burden will be evaluated using NGS after 2-cycle chemotherapy, 4-cycle chemotherapy, or at progressive disease

Arm

Intervention/Treatment

Chemotherapy Group

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

Other: Next-Genernation Sequence

Tumor Mutation burden will be evaluated using NGS after 2-cycle chemotherapy, 4-cycle chemotherapy, or at progressive disease

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Changzheng Hospital	Shanghai	Shanghai	China	200003

Sponsors and Collaborators

Baodong Qin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Baodong Qin, Principal Investigator, Shanghai Changzheng Hospital

ClinicalTrials.gov Identifier:

NCT03683407

Other Study ID Numbers:

COTMB

First Posted:

Sep 25, 2018

Last Update Posted:

Sep 25, 2018

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 25, 2018