Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations

NCT07369596 | Recruiting

• 1 other identifier: 20258615434
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Non Small Cell Lung Carcinoma NSCLC

Keywords

NSCLC; older patients; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of study on 31 Dec 2026

Secondary Outcomes (2)

• To compare the progression free survival (PFS) between older NSCLC patients treated with standard-dose versus reduced-dose first-line platinum-doublet chemotherapy OR single agent non-platinum chemotherapy.

  From enrollment to end of study on 31 Dec 2026

• To assess objective response rates in patients who complete FOUR cycles of chemotherapy.

  From enrollment to end of study period on 31 Dec 2026

Study Arms (2)

Normal dose group

Patients receiving standard dose of chemotherapy

Other: Progression free survival; Other: Overall survival

Dose reduction group

Patients receiving lower doses of chemotherapy

Other: Progression free survival; Other: Overall survival

Interventions

Progression free survival OTHER

PFS

Dose reduction group; Normal dose group

Overall survival OTHER

OS

Dose reduction group; Normal dose group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective cohort study using data from three centres in Malaysia from 2020 to 2025. All patients aged ≥65 years with advanced/metastatic NSCLC and no actionable driver mutations who received AT LEAST ONE CYCLE of first-line chemotherapy will be included in the analysis.

You may qualify if:

• 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

You may not qualify if:

• Patients who received targeted therapy or immunotherapy as monotherapy in the first-line setting
• Incomplete survival data

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (4)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, Malaysia

RECRUITING

Hospital Wanita dan Kanak-Kanak Sabah

Kota Kinabalu, Sabah, Malaysia

RECRUITING

Universiti Malaya Medical Centre

Kuala Lumpur, Malaysia

RECRUITING

Related Publications (10)

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  PMID: 27229180 BACKGROUND

• Solomon 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 BACKGROUND

• Mok 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 BACKGROUND

• 7. 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.

  BACKGROUND

• Hurria 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 BACKGROUND

• Maione 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.

  PMID: 16192578 BACKGROUND

• Sundararajan V, Hershman D, Grann VR, Jacobson JS, Neugut AI. Variations in the use of chemotherapy for elderly patients with advanced ovarian cancer: a population-based study. J Clin Oncol. 2002 Jan 1;20(1):173-8. doi: 10.1200/JCO.2002.20.1.173.

  PMID: 11773167 BACKGROUND

• 3. Liam, Chong-Kin, Toh-Yoon Evelyn Goh, Nur Syafikah Shamsudin, and Chee-Chee Khoo. 2022. "Driver Gene Alterations and PD-L1 Expression in Non-Small Cell Lung Cancer and Their Association with Smoking and Gender in a Malaysian Population." Asian Pacific Journal of Cancer Prevention 23 (6): 1911-1917.

  BACKGROUND

• Hurria A, Togawa K, Mohile SG, Owusu C, Klepin HD, Gross CP, Lichtman SM, Gajra A, Bhatia S, Katheria V, Klapper S, Hansen K, Ramani R, Lachs M, Wong FL, Tew WP. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011 Sep 1;29(25):3457-65. doi: 10.1200/JCO.2011.34.7625. Epub 2011 Aug 1.

  PMID: 21810685 BACKGROUND

• Hamaker ME, Schiphorst AH, ten Bokkel Huinink D, Schaar C, van Munster BC. The effect of a geriatric evaluation on treatment decisions for older cancer patients--a systematic review. Acta Oncol. 2014 Mar;53(3):289-96. doi: 10.3109/0284186X.2013.840741. Epub 2013 Oct 17.

  PMID: 24134505 BACKGROUND

MeSH Terms

Interventions

Progression-Free Survival

Intervention Hierarchy (Ancestors)

Treatment Outcome; Prognosis; Diagnosis; Survival Analysis; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mau Ern Poh, MBBS

  Universiti Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mau Ern Poh, MBBS

CONTACT

+60379494422; ernestpoh@um.edu.my

Danouska Bala Krishnan

CONTACT

+603-79492351; danouska@ummc.edu.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); MY (3)