Clinical trial NCT04722406: Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.
Official title: Tumor Growth Rate (TGR) as an Early Predictor of Clinical Outcomes in Advanced Non-small Cell Lung Cancer Treated With PD-1 Axis Inhibitors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Lung Cancer
Keywords: Tumor Growth Rate
NSCLC
immunotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Shanghai Chest Hospital
First posted: 2021-01-25
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy (N = 172) at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.

Brief summary: We hypothesized that TGR could serve as an early predictor of outcomes for aNSCLC patients undergoing immune checkpoint inhibitors (ICIs). A retrospective analysis was conducted to investigate the association of TGR with response and long-term survival of aNSCLC patients undergoing ICI therapy.

Detailed description: Tumor growth rate (TGR) signifies percentage change in tumor size per month (%/m). Electronic medical records were retrospectively reviewed for all histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.

All response and outcome evaluation were determined as per RECIST 1.1 by two senior radiologists blinded to patients'information. Discrepancy was solved by consensus.

X-tile software was used to determine cut-off values that maximumly differentiate overall survival (OS). Log-rank tests and Cox regression models were performed for survival analysis. The predictive value of TGR for clinical outcomes in ICI-treated aNSCLC patients was validated in two external cohorts, recruited form Guangdong Province Traditional Chinese Medical Hospital and Shanghai Chest Hospital.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed aNSCLC patients
* Having received anti-PD-1/PD-L1 therapy
* Must have two consecutive computed tomography (CT) scans upon early treatment (from baseline to the first imaging evaluation)

Exclusion Criteria:

* Lacking available computed tomography (CT) evaluation at any of two time points-baseline and the first evaluation
* Without measurable lesions at baseline CT scan
* Having received local anticancer therapy during ICI treatment, for example, radiotherapy and radiofrequency ablation

Primary outcomes:
measure: Overall survival of patients undergoing ICI monotherapy
timeFrame: From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.
Secondary outcomes:
measure: Progression-free survival of patients undergoing ICI monotherapy.
timeFrame: From date of ICI treatment initiation until the date of first documented progression or date of death from any causes, whichever came first, assessed up to 100 months.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Shanghai
country: China
facility: Shaihai Chest Hospital
state: Shanghai
Study officials:
affiliation: Sun Yat-sen University
name: Shaodong Hong, MD
role: PRINCIPAL_INVESTIGATOR
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