Liquid biopsy guided addition of chemotherapy with TKI in advanced EGFR mutated NSCLC.

Liquid biopsy guided addition of chemotherapy with TKI in advanced EGFR mutated NSCLC: An open-label, multicentric, phase 3 randomized controlled trial (LiquiACT) - LiquiACT

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079687

Enrollment

354

Registered

2025-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: gefitinib 250 mg or Osimertinib 80 mg: Intervention arm will receive TKI of physician choice- gefitinib 250 mg per oral once a day or Osimertinib 80 mg per oral once a day. Blood sample

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years 2. Treatment naive patients with stage 3B and C (not amenable for curative intent treatment) and stage 4 disease (as per AJCC 8th edition) 3. ECOG performance status 0 and 1 4. Pathological diagnosis of non-squamous non-small cell lung cancer 5. Presence of sensitizing EGFR mutations (exon 19 del and L858R) detected on either tissue or plasma ct DNA. 6. Adequate bone marrow functions defined as haemoglobin greater than or equal to 9 gm/dl, absolute neutrophil counts greater than or equal to 1500 and platelet counts greater than or equal to 100,000. 7. Adequate renal functions defined as creatinine clearance (calculated by Cockraft Gault formula) greater than or equal to 45 ml/min 8. Adequate hepatic functions defined as AST/ALT less than or equal to 2 times upper normal limit and normal bilirubin.

Exclusion criteria

Exclusion criteria: 1. Rare and compound EGFR mutations. 2. Symptomatic and untreated brain metastasis (treated and asymptomatic brain metastasis would be allowed). 3. Pre-existing interstitial lung disease (symptomatic or radiological). 4. Pregnancy and lactation 5. HIV positive

Design outcomes

Primary

Measure	Time frame
Overall survival rates in the intention to treat population, defined as time from enrolment till death or 2 years for all enrolled patientsTimepoint: Overall survival rates at 2 years	—

Secondary

Measure	Time frame
a. Toxicity profile, b. Quality of life, c. Progression free survival, and d. Cost analysis of both approachesTimepoint: Over the entire study period	—

Countries

India

Contacts

Public ContactDr Prabhat Singh Malik

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

drprabhatsm@gmail.com09968325318

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026