Clinical trial · Observational
Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.
Tumor Growth Rate (TGR) as an Early Predictor of Clinical Outcomes in Advanced Non-small Cell Lung Cancer Treated With PD-1 Axis Inhibitors.
NCT04722406CI-TRIAL-00050701unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| This item is not applicable to our observational study. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Low TGR group
- description
- Patients with low level of TGR determined by X-tile program
- interventionNames
- Other: This item is not applicable to our observational study.
- label
- High TGR group
- description
- Patients with high level of TGR determined by X-tile program
- interventionNames
- Other: This item is not applicable to our observational study.
Primary outcomes (1)
- 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.
- description
- Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDAntonia 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. PMID 31422028
- BACKGROUNDXia 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. PMID 30819829
- BACKGROUNDMok 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. PMID 30955977
- BACKGROUNDGettinger 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. PMID 29570421
- BACKGROUNDFerte 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. PMID 24240109
- Lamarca 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.