Clinical trial Recruiting at 4 sites Observational Ages 65 and up

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.

More Non-small Cell Lung Cancer (NSCLC) trials

Quick facts

Study typeObservational
Ages65 Years and up
SexAll
Enrollment150 (estimated)
SponsorUniversity of Malaya
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations4 sites (Hong Kong and 3 other locations)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJune 2, 2026
Trial IDNCT07369596 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.