Clinical trial · Observational
Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations
Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations: A Retrospective Cohort Study.
- 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)
Evidence suggests that appropriately selected older adults can tolerate standard-dose chemotherapy and achieve survival outcomes comparable to younger patients. However, older adults are usually under-represented in clinical trials and often receive reduced doses of chemotherapy due to concerns regarding age-related frailty, polypharmacy, and toxicity. This study seeks to evaluate chemotherapy dosing patterns and associated survival outcomes in older patients.
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 Carcinoma NSCLC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Overall survival | Other | — | UNRESOLVED |
| Progression free survival | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Normal dose group
- description
- Patients receiving standard dose of chemotherapy
- interventionNames
- Other: Progression free survival
- Other: Overall survival
- label
- Dose reduction group
- description
- Patients receiving lower doses of chemotherapy
- interventionNames
- Other: Progression free survival
- Other: Overall survival
Primary outcomes (1)
- measure
- To compare the overall survival (OS) between older NSCLC patients treated with standard-dose versus reduced-dose first-line platinum-doublet chemotherapy OR single agent non-platinum chemotherapy.
- timeFrame
- From enrollment to the end of study on 31 Dec 2026
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥65 years * Histologically confirmed stage IV NSCLC * Negative for EGFR mutation, ALK rearrangement, and ROS1 fusion * Treated with at least ONE cycle of first-line chemotherapy Exclusion Criteria: * Patients who received targeted therapy or immunotherapy as monotherapy in the first-line setting * Incomplete survival data
References
Publications (10)
- BACKGROUNDTan DS, Yom SS, Tsao MS, Pass HI, Kelly K, Peled N, Yung RC, Wistuba II, Yatabe Y, Unger M, Mack PC, Wynes MW, Mitsudomi T, Weder W, Yankelevitz D, Herbst RS, Gandara DR, Carbone DP, Bunn PA Jr, Mok TS, Hirsch FR. The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation-Positive Non-Small Cell Lung Cancer: Status in 2016. J Thorac Oncol. 2016 Jul;11(7):946-63. doi: 10.1016/j.jtho.2016.05.008. Epub 2016 May 23. PMID 27229180
- BACKGROUNDSolomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440. PMID 25470694
- BACKGROUNDMok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19. PMID 19692680
- BACKGROUND7. Sedrak MS, Sun CL, Liu X, et al. Aging and tolerance to chemotherapy: Impact of dose reduction and treatment delays on survival outcomes. Journal of Clinical Oncology, 2021 39, 1714-1723.
- BACKGROUNDHurria A, Kris MG. Management of lung cancer in older adults. CA Cancer J Clin. 2003 Nov-Dec;53(6):325-41. doi: 10.3322/canjclin.53.6.325. PMID 15224973
- BACKGROUNDMaione P, Perrone F, Gallo C, Manzione L, Piantedosi F, Barbera S, Cigolari S, Rosetti F, Piazza E, Robbiati SF, Bertetto O, Novello S, Migliorino MR, Favaretto A, Spatafora M, Ferrau F, Frontini L, Bearz A, Repetto L, Gridelli C, Barletta E, Barzelloni ML, Iaffaioli RV, De Maio E, Di Maio M, De Feo G, Sigoriello G, Chiodini P, Cioffi A, Guardasole V, Angelini V, Rossi A, Bilancia D, Germano D, Lamberti A, Pontillo V, Brancaccio L, Renda F, Romano F, Esani G, Gambaro A, Vinante O, Azzarello G, Clerici M, Bollina R, Belloni P, Sannicolo M, Ciuffreda L, Parello G, Cabiddu M, Sacco C, Sibau A, Porcile G, Castiglione F, Ostellino O, Monfardini S, Stefani M, Scagliotti G, Selvaggi G, De Marinis F, Martelli O, Gasparini G, Morabito A, Gattuso D, Colucci G, Galetta D, Giotta F, Gebbia V, Borsellino N, Testa A, Malaponte E, Capuano MA, Angiolillo M, Sollitto F, Tirelli U, Spazzapan S, Adamo V, Altavilla G, Scimone A, Hopps MR, Tartamella F, Ianniello GP, Tinessa V, Failla G, Bordonaro R, Gebbia N, Valerio MR, D'Aprile M, Veltri E, Tonato M, Darwish S, Romito S, Carrozza F, Barni S, Ardizzoia A, Corradini GM, Pavia G, Belli M, Colantuoni G, Galligioni E, Caffo O, Labianca R, Quadri A, Cortesi E, D'Auria G, Fava S, Calcagno A, Luporini G, Locatelli MC, Di Costanzo F, Gasperoni S, Isa L, Candido P, Gaion F, Palazzolo G, Nettis G, Annamaria A, Rinaldi M, Lopez M, Felletti R, Di Negro GB, Rossi N, Calandriello A, Maiorino L, Mattioli R, Celano A, Schiavon S, Illiano A, Raucci CA, Caruso M, Foa P, Tonini G, Curcio C, Cazzaniga M. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancer receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the elderly study. J Clin Oncol. 2005 Oct 1;23(28):6865-72. doi: 10.1200/JCO.2005.02.527.