CClinicalTrials.gg
Status unknownNCT03683407Updated Sep 25, 2018

Effect of Chemotherapy on TMB in NSCLC

An observational study in Chemotherapy Effect, Immunotherapy and Tumor Mutation Burden, sponsored by Baodong Qin. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-25.

Sponsored by Baodong Qin · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Chemotherapy Effect
  • Immunotherapy
  • Tumor Mutation Burden
  • PD-1/L1 Inhibitor
03

In context

Lead sponsor

Baodong Qin is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Advanced NSCLC without druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)

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

Exclusion Criteria:

  • Patient can not comply with research program requirements or follow-up;
  • Patient will receive immunotherapy;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherNext-Genernation Sequence

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

06

What researchers measure

Primary outcomes

  1. Tumor Mutation Burden Change

    Tumor mutation burden will be calculated using a 520 genes NGS panel

    Time frame: every 6 weeks up to progression disease

07

Study locations

1 of 1 sites recruiting
  • Shanghai Changzheng Hospital
    Shanghai, Shanghai 200003, China
    • Xiao-Dong Jiao, MD · Contact · pulava@139.com · +86-13817797639
    • Yuan-Sheng Zang, Professor · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03683407
Lead sponsor
Baodong Qin
Responsible party
Baodong Qin (Principal Investigator, Shanghai Changzheng Hospital) — Sponsor-investigator
First posted
Sep 25, 2018
Start date
Sep 1, 2018
Primary completion
Feb 28, 2019 (estimated)
Completion
Aug 31, 2019 (estimated)
Last update
Sep 25, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion