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.
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.
4 sites in 2 countries
Malaysia3 sites, 3 recruiting
- 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
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Wang Chun Kwok, +85222556208, kwokwch@hku.hk
Chun Kwok Wang
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.
- Conditions
- Non Small Cell Lung Carcinoma NSCLC
- 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 group | Role | What they receive |
|---|---|---|
| Normal dose group | Patients receiving standard dose of chemotherapy Receives: Other: Progression free survival; Other: Overall survival | |
| Dose reduction group | Patients 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.
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)
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
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.
- First posted27 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Carcinoma NSCLCStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poh Mau Ern, University of Malaya
- Investigators
- Mau Ern Poh, MBBS, Principal investigator, University of Malaya
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 27229180Solomon 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 25470694Mok 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 196926807. 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 15224973Maione 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 16192578Sundararajan 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 117731673. 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 21810685Hamaker 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations: A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT07369596
- Acronym / sponsor ID
- 20258615434
- Conditions
- Non Small Cell Lung Carcinoma NSCLC
- Keywords
- NSCLC, older patients, chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2026 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal dose group | – | Other: Progression free survival, Other: Overall survivalPatients receiving standard dose of chemotherapy |
| Dose reduction group | – | Other: Progression free survival, Other: Overall survivalPatients receiving lower doses of chemotherapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who received targeted therapy or immunotherapy as monotherapy in the first-line setting
- Incomplete survival data
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 |
|---|---|---|
| Progression free survivalPFS | Other | Dose reduction group, Normal dose group |
| Overall survivalOS | Other | Dose reduction group, Normal dose group |
Primary outcome
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
2 secondary outcomes
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.
Time frame: From enrollment to end of study on 31 Dec 2026
To assess objective response rates in patients who complete FOUR cycles of chemotherapy.
Time frame: From enrollment to end of study period on 31 Dec 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 27229180Tan 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.
- Background: PubMed 25470694Solomon 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.
- Background: PubMed 19692680Mok 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.
- 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.
- Background: PubMed 15224973Hurria 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.
- Background: PubMed 16192578Maione 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.
- Background: PubMed 11773167Sundararajan 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.
- Background3. 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: PubMed 21810685Hurria 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.
- Background: PubMed 24134505Hamaker 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.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Carcinoma NSCLC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Mau Ern Poh, MBBS principal investigator
University of Malaya
4 sites in 2 countries: see every site and its status.
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.