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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Malaya

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who received targeted therapy or immunotherapy as monotherapy in the first-line setting

Incomplete survival data

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Progression free survival

    Other intervention

    PFS

  • Overall survival

    Other intervention

    OS

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Normal dose group2 interventions
Group B: Dose reduction group2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
From enrollment to the end of study on 31 Dec 2026

Secondary outcomes

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.

Time frame
From enrollment to end of study on 31 Dec 2026
2

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

Other outcomes

Sponsors and contacts

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