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A Prospective Observational Study of cfDNA Monitoring in Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Prospective Observational Study of cfDNA-Guided Monitoring in Metastatic, Driver Mutation-Negative, Non-Small Cell Lung Cancer (NSCLC) - NSCLC_CfDNA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098710
Enrollment
139
Registered
2025-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil Intervention6: Nil: Nil

Sponsors

MOC Cancer Care and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed diagnosis of stage IV non-snmall cell lung cancer (NSCLC). Actionable Mutation-negative (EGFR, ALK, ROS, MET, NTRK, RET) and molecularly na ve (no prior molecular testing for actionable mutations or targeted therapy). Age more than 18 years. Either of the Gender. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. No prior systemic therapy for mnetastatic disease (first cycle taken before testing will be included). Except treated asymptomatic stable Brain metastasis. Ability to provide written informed consent and comply with study procedures. Patients willing to undergo regular cfDNA testing and PET-CT scans as part of study monitoring.

Exclusion criteria

Exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status of more than 2. Patients with mutations or other actionable molecular alterations that would qualify for targeted therapy. Symptomatic Brain Metastasis. Patients with previous treatment for metastatic NSCLC. Patients with other active malignancies. Pregnant or breastfeeding women. Inability to undergo cfDNA testing or PET-CT scans due to technical or logistical reasons. Any other condition that, in the investigators opinion, would make the patient unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
To evaluate whether rising cfDNA/ctDNA levels can identify molecular progressive disease (mPD) cutoff earlier than conventional radiological assessment.Timepoint: follow up every three months

Secondary

MeasureTime frame
The Secondary endpoints Overall Survival, Quality of Life (QOL) assessed using validated questionnaires.Timepoint: at baseline & on completion of treatment

Countries

India

Contacts

Public ContactDr Udip Maheshwari

MOC Cancer Care and Research Centre

drudipdm@mocindia.co.in7677434237

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026