Non-Small Cell Lung CancerNCT04722406
Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.
An observational study of Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- This item is not applicable to our observational study.
- How many people
- 350 participants
- Where
- 3 sitesChina
- Study dates
- 15 Aug 2019to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Shaodong Hong, MD, +8615920527656, hongshd@sysucc.org.cn
Shaodong Hong, MD
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Haibo Zhang, MD, +8613724123615, haibozh@gzucm.edu.cn
- Recruiting
Shaihai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Xiaomin Niu, MD, PhD, +8613917040510, ar_tey@hotmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- This item is not applicable to our observational study.
- Keywords
- Tumor Growth Rate, NSCLC, immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This item is not applicable to our observational study.Other
This item is not applicable to our observational study.
| Study group | Role | What they receive |
|---|---|---|
| Low TGR group | Patients with low level of TGR determined by X-tile program Receives: Other: This item is not applicable to our observational study. | |
| High TGR group | Patients with high level of TGR determined by X-tile program Receives: Other: This item is not applicable to our observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of patients undergoing ICI monotherapy
Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.
Measured: From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start15 Aug 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital
- Responsible party
- Principal investigator, Shaodong Hong, Sun Yat-sen University
- Investigators
- Shaodong Hong, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722406
- Sponsor's protocol ID
- SHong
- Status last verified
- Mar 2021
- First submitted
- 18 Jan 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data including demographic characteristics, clinical information, radiological and follow-up information will be shared.
Publications
Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeno J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crino L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J. Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis. Lancet Oncol. 2019 Oct;20(10):1395-1408. doi: 10.1016/S1470-2045(19)30407-3. Epub 2019 Aug 14.
PubMed 31422028Xia 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.
PubMed 30819829Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7. Epub 2019 Apr 4.
PubMed 30955977Gettinger S, Horn L, Jackman D, Spigel D, Antonia S, Hellmann M, Powderly J, Heist R, Sequist LV, Smith DC, Leming P, Geese WJ, Yoon D, Li A, Brahmer J. Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study. J Clin Oncol. 2018 Jun 10;36(17):1675-1684. doi: 10.1200/JCO.2017.77.0412. Epub 2018 Mar 23.
PubMed 29570421Ferte C, Fernandez M, Hollebecque A, Koscielny S, Levy A, Massard C, Balheda R, Bot B, Gomez-Roca C, Dromain C, Ammari S, Soria JC. Tumor growth rate is an early indicator of antitumor drug activity in phase I clinical trials. Clin Cancer Res. 2014 Jan 1;20(1):246-52. doi: 10.1158/1078-0432.CCR-13-2098. Epub 2013 Nov 15.
PubMed 24240109Lamarca A, Crona J, Ronot M, Opalinska M, Lopez Lopez C, Pezzutti D, Najran P, Carvhalo L, Franca Bezerra RO, Borg P, Vietti Violi N, Vidal Trueba H, de Mestier L, Schaefer N, Sundin A, Costa F, Pavel M, Dromain C; Knowledge Network. Value of Tumor Growth Rate (TGR) as an Early Biomarker Predictor of Patients' Outcome in Neuroendocrine Tumors (NET)-The GREPONET Study. Oncologist. 2019 Nov;24(11):e1082-e1090. doi: 10.1634/theoncologist.2018-0672. Epub 2019 Mar 25.
PubMed 30910869Stein WD, Wilkerson J, Kim ST, Huang X, Motzer RJ, Fojo AT, Bates SE. Analyzing the pivotal trial that compared sunitinib and IFN-alpha 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.
PubMed 22344231Gomez-Roca C, Koscielny S, Ribrag V, Dromain C, Marzouk I, Bidault F, Bahleda R, Ferte 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.
PubMed 21763126Camp RL, Dolled-Filhart M, Rimm DL. X-tile: a new bio-informatics tool for biomarker assessment and outcome-based cut-point optimization. Clin Cancer Res. 2004 Nov 1;10(21):7252-9. doi: 10.1158/1078-0432.CCR-04-0713.
PubMed 15534099He LN, Fu S, Ma H, Chen C, Zhang X, Li H, Du W, Chen T, Jiang Y, Wang Y, Wang Y, Zhou Y, Lin Z, Yang Y, Huang Y, Zhao H, Fang W, Zhang H, Zhang L, Hong S. Early on-treatment tumor growth rate (EOT-TGR) determines treatment outcomes of advanced non-small-cell lung cancer patients treated with programmed cell death protein 1 axis inhibitor. ESMO Open. 2022 Dec;7(6):100630. doi: 10.1016/j.esmoop.2022.100630. Epub 2022 Nov 25.
PubMed 36442353
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04722406
- Acronym / sponsor ID
- SHong
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Tumor Growth Rate, NSCLC, immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low TGR group | – | Other: This item is not applicable to our observational study.Patients with low level of TGR determined by X-tile program |
| High TGR group | – | Other: This item is not applicable to our observational study.Patients with high level of TGR determined by X-tile program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This item is not applicable to our observational study.This item is not applicable to our observational study. | Other | High TGR group, Low TGR group |
Primary outcome
Overall survival of patients undergoing ICI monotherapy
Time frame: From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.
Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.
1 secondary outcome
Progression-free survival of patients undergoing ICI monotherapy.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 31422028Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeno J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crino L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J. Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis. Lancet Oncol. 2019 Oct;20(10):1395-1408. doi: 10.1016/S1470-2045(19)30407-3. Epub 2019 Aug 14.
- Background: PubMed 30819829Xia 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.
- Background: PubMed 30955977Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7. Epub 2019 Apr 4.
- Background: PubMed 29570421Gettinger S, Horn L, Jackman D, Spigel D, Antonia S, Hellmann M, Powderly J, Heist R, Sequist LV, Smith DC, Leming P, Geese WJ, Yoon D, Li A, Brahmer J. Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study. J Clin Oncol. 2018 Jun 10;36(17):1675-1684. doi: 10.1200/JCO.2017.77.0412. Epub 2018 Mar 23.
- Background: PubMed 24240109Ferte C, Fernandez M, Hollebecque A, Koscielny S, Levy A, Massard C, Balheda R, Bot B, Gomez-Roca C, Dromain C, Ammari S, Soria JC. Tumor growth rate is an early indicator of antitumor drug activity in phase I clinical trials. Clin Cancer Res. 2014 Jan 1;20(1):246-52. doi: 10.1158/1078-0432.CCR-13-2098. Epub 2013 Nov 15.
- Background: PubMed 30910869Lamarca A, Crona J, Ronot M, Opalinska M, Lopez Lopez C, Pezzutti D, Najran P, Carvhalo L, Franca Bezerra RO, Borg P, Vietti Violi N, Vidal Trueba H, de Mestier L, Schaefer N, Sundin A, Costa F, Pavel M, Dromain C; Knowledge Network. Value of Tumor Growth Rate (TGR) as an Early Biomarker Predictor of Patients' Outcome in Neuroendocrine Tumors (NET)-The GREPONET Study. Oncologist. 2019 Nov;24(11):e1082-e1090. doi: 10.1634/theoncologist.2018-0672. Epub 2019 Mar 25.
- Background: PubMed 22344231Stein WD, Wilkerson J, Kim ST, Huang X, Motzer RJ, Fojo AT, Bates SE. Analyzing the pivotal trial that compared sunitinib and IFN-alpha 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.
- Background: PubMed 21763126Gomez-Roca C, Koscielny S, Ribrag V, Dromain C, Marzouk I, Bidault F, Bahleda R, Ferte 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.
- Background: PubMed 15534099Camp RL, Dolled-Filhart M, Rimm DL. X-tile: a new bio-informatics tool for biomarker assessment and outcome-based cut-point optimization. Clin Cancer Res. 2004 Nov 1;10(21):7252-9. doi: 10.1158/1078-0432.CCR-04-0713.
- Derived from this study: PubMed 36442353He LN, Fu S, Ma H, Chen C, Zhang X, Li H, Du W, Chen T, Jiang Y, Wang Y, Wang Y, Zhou Y, Lin Z, Yang Y, Huang Y, Zhao H, Fang W, Zhang H, Zhang L, Hong S. Early on-treatment tumor growth rate (EOT-TGR) determines treatment outcomes of advanced non-small-cell lung cancer patients treated with programmed cell death protein 1 axis inhibitor. ESMO Open. 2022 Dec;7(6):100630. doi: 10.1016/j.esmoop.2022.100630. Epub 2022 Nov 25.
- Individual participant dataSharing planned: Yes. Data including demographic characteristics, clinical information, radiological and follow-up information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaodong Hong, MD principal investigator
Sun Yat-sen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaodong Hong, MD (+8615920527656, hongshd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of patients undergoing ICI monotherapy (time frame: From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722406, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.