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Non Small Cell Lung Carcinoma NSCLCNCT07369596

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

An observational study of Non Small Cell Lung Carcinoma NSCLC, run by University of Malaya at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Non Small Cell Lung Carcinoma NSCLC
What is being tested?
Progression free survival and Overall survival
How many people
150 participants
Where
4 sitesin 2 countries
Study dates
1 Jan 2026to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Mau Ern Poh, MBBS contact

+60379494422

ernestpoh@um.edu.my

Danouska Bala Krishnan contact

+603-79492351

danouska@ummc.edu.my

4 sites in 2 countries

Malaysia3 sites, 3 recruiting
  • Hospital Wanita dan Kanak-Kanak Sabah

    Kota Kinabalu, Sabah

    Seng Wee Cheo, +6088522600, cheosengwee@gmail.com

    Seng Wee Cheo

    Recruiting
  • Universiti Malaya Medical Centre

    Kuala Lumpur

    Mau Ern Poh, MBBS, +60379494422, ernestpoh@um.edu.my

    Mau Ern Poh

    Recruiting
  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang

    Sin Nee Tan, +6095572222, christine0507@live.com

    Sin Nee Tan

    Recruiting

Other trials in Malaysia

Hong Kong1 site, 1 recruiting
  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

    Wang Chun Kwok, +85222556208, kwokwch@hku.hk

    Chun Kwok Wang

    Recruiting

Other trials in Hong Kong

About this study

Official title: Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations: A Retrospective Cohort Study.

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.

Read the detailed description

Lung cancer remains the leading cause of cancer-related mortality globally, responsible for approximately 1.8 million deaths annually. Non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, with adenocarcinoma (ADC) now the predominant histological subtype. In Malaysia, NSCLC is similarly the most common form of lung cancer, with high proportions of EGFR and ALK mutations in certain subgroups.

Despite the emergence of targeted therapy and immunotherapy, cytotoxic chemotherapy, particularly platinum-based doublets remains the backbone of treatment for many NSCLC patients lacking actionable mutations. These patients often present with advanced disease and limited survival prospects, with median overall survival (OS) of 8- 10 months. These includes older patients with advanced NSCLC and no actionable mutations who depend on chemotherapy for disease control.

Clinical decisions regarding dosing are frequently influenced by perceptions of frailty rather than individual fitness. 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 raises an important question: does dose reduction compromise survival outcomes in older NSCLC patients?

This study seeks to address this knowledge gap by retrospectively evaluating chemotherapy dosing patterns and associated survival outcomes in older patients treated at three centres in Malaysia: Universiti Malaya Medical Centre (UMMC), Hospital Tengku Ampuan Afzan, Kuantan and Hospital Wanita dan Kanak-kanak, Likas, Sabah and one centre in Hong Kong: Queen Mary Hospital, The University of Hong Kong. It will evaluate whether chemotherapy dose reductions are associated with poorer survival outcomes in older NSCLC patients. It will also assess clinical predictors such as ECOG performance status, BMI, comorbidities, and gender to identify factors influencing treatment tolerance and survival.

Being tested
Progression free survival, Overall survival
Keywords
NSCLC, older patients, chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progression free survivalOther

    PFS

  • Overall survivalOther

    OS

Study groups in NCT07369596
Study groupRoleWhat they receive
Normal dose groupPatients receiving standard dose of chemotherapy
Receives: Other: Progression free survival; Other: Overall survival
Dose reduction groupPatients receiving lower doses of chemotherapy
Receives: Other: Progression free survival; Other: Overall survival

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of study on 31 Dec 2026

Secondary outcomes (2)
  1. 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.

    Measured: From enrollment to end of study on 31 Dec 2026

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

    Measured: From enrollment to end of study period on 31 Dec 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2026
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07369596
Sponsor's protocol ID
20258615434
Status last verified
May 2026
First submitted
22 Dec 2025
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tan 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.

    PubMed 27229180
  • 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.

    PubMed 25470694
  • 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.

    PubMed 19692680
  • 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.

  • 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.

    PubMed 15224973
  • 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.

    PubMed 16192578
  • 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.

    PubMed 11773167
  • 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.

  • 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.

    PubMed 21810685
  • 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.

    PubMed 24134505

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Carcinoma NSCLC, run by University of Malaya at 4 sites in 2 countries.

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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Malaysia, Hong Kong. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mau Ern Poh, MBBS (+60379494422, ernestpoh@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: From enrollment to the end of study on 31 Dec 2026). 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 NCT07369596, 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 2 Jun 2026.

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