How reducing chemotherapy doses affects survival in older people with NSCLC who do not have targetable mutations
Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations: A Retrospective Cohort Study.
University of Malaya · NCT07369596
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Malaya (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Hong Kong and 3 other locations) |
| Trial ID | NCT07369596 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hong Kong and 3 other locations
- 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 — Universiti Malaya
- Study coordinator: Mau Ern Poh, MBBS
- Email: ernestpoh@um.edu.my
- Phone: +60379494422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non Small Cell Lung Carcinoma NSCLC, NSCLC, older patients, chemotherapy