Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.

Non-Small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722406
• Other study ID #: SHong
• Status: Recruiting
• Start date: August 15, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2021
• Source: Sun Yat-sen University
• Contact: Shaodong Hong, MD
• Phone: +8615920527656
• Email: hongshd[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Other:
• This item is not applicable to our observational study.
This item is not applicable to our observational study.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Shaihai Chest Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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Gomez-Roca C, Koscielny S, Ribrag V, Dromain C, Marzouk I, Bidault F, Bahleda R, Ferté C, Massard C, Soria JC. Tumour growth rates and RECIST criteria in early drug development. Eur J Cancer. 2011 Nov;47(17):2512-6. doi: 10.1016/j.ejca.2011.06.012. Epub 2011 Jul 15. — View Citation

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Stein WD, Wilkerson J, Kim ST, Huang X, Motzer RJ, Fojo AT, Bates SE. Analyzing the pivotal trial that compared sunitinib and IFN-a in renal cell carcinoma, using a method that assesses tumor regression and growth. Clin Cancer Res. 2012 Apr 15;18(8):2374-81. doi: 10.1158/1078-0432.CCR-11-2275. Epub 2012 Feb 17. — View Citation

Xia L, Liu Y, Wang Y. PD-1/PD-L1 Blockade Therapy in Advanced Non-Small-Cell Lung Cancer: Current Status and Future Directions. Oncologist. 2019 Feb;24(Suppl 1):S31-S41. doi: 10.1634/theoncologist.2019-IO-S1-s05. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival of patients undergoing ICI monotherapy	Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.	From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.
Secondary	Progression-free survival of patients undergoing ICI monotherapy.	Progression-free survival was calculated from ICI initiation to radiologically-defined progression or death from any causes.	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.