How reducing chemotherapy doses affects survival in older people with NSCLC who do not have targetable mutations
Official title: Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations: A Retrospective Cohort Study.
Run by University of Malaya · NCT07369596 · Data updated 2026-11-12
This project will see if giving lower doses of chemotherapy to people aged 65 and older with advanced NSCLC without EGFR/ALK/ROS1 mutations changes their survival.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Malaya Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Hong Kong and 3 other locations) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07369596 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 65 or older with stage IV NSCLC lacking EGFR, ALK, and ROS1 alterations who received at least one cycle of first-line chemotherapy at a participating center.
✕Probably not a fit
Patients with actionable mutations who receive targeted therapy, those given immunotherapy as first-line treatment, people with incomplete survival records, or those with earlier-stage disease are not likely to benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study reviews treatment records of patients aged 65 and older with stage IV NSCLC who lack EGFR, ALK, and ROS1 alterations and received at least one cycle of first-line chemotherapy. It compares chemotherapy dosing patterns, including dose reductions, with outcomes such as progression-free survival and overall survival. Patients who received targeted therapy or first-line immunotherapy or who have incomplete survival data are excluded. Data are collected from participating hospitals in Malaysia and Hong Kong and analyzed to identify associations between dose intensity and survival outcomes.
Why it matters
Potential benefit: If positive, the findings could help clinicians choose chemotherapy doses that preserve survival while reducing unnecessary toxicity for older patients.
How similar studies have gone: Previous observational work suggests some older adults tolerate full-dose chemotherapy with survival comparable to younger patients, but data specifically linking dose reductions to survival outcomes are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
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
Study contacts
- Principal investigator: Mau Ern Poh, MBBS — University of Malaya
- Study coordinator: Mau Ern Poh, MBBS
- Email: ernestpoh@um.edu.my
- Phone: +60379494422
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
New total-body PET scanner test in people with NSCLC, head and neck cancer, and prostate cancer
Researchers are testing a new total-body PET scanner called Biograph Vision Quadra to see if it provides clearer images and more information than standard PET/CT in people with certain cancers.
-
SCTB14 as first-line therapy for advanced NSCLC
This trial will test whether SCTB14 works better than pembrolizumab as first treatment for adults with unresectable locally advanced or metastatic, driver-gene–negative NSCLC whose tumors have PD-L1 TPS ≥10%.
-
PF-08098488 in adults with advanced solid tumors
This study tests PF-08098488 in adults whose cancer has progressed or returned after prior treatment.
-
Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC
This study tests whether using Cryo-Thermal Ablation before chemo-immunotherapy helps people with resectable NSCLC see better outcomes.
-
Vortioxetine for cognitive problems in ALK/ROS1-positive NSCLC treated with lorlatinib
This observational study tests whether vortioxetine can help with cognitive and neurological side effects in adults with ALK/ROS1-positive NSCLC who are taking lorlatinib.
-
PF-08634404 Alone or with chemotherapy in early-stage or locally advanced NSCLC
This study tests PF-08634404 by itself or with chemotherapy in adults with early-stage or locally advanced non-small cell lung cancer that may be surgically removable or were candidates for additional therapy after initial treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.