FindTrial
Sign In

To determine whether the intensification of treatment in the form of chemotherapy and EGFR TKI gefitinib) combination increases survival among a â??high riskâ?? sub population of patients with lung cancer who have an EGFR mutation

A phase II randomised controlled trial of Interim Response Adapted Therapy based on mutant allele frequency (MAF) of plasma EGFR mutation (or) inadequate radiological response among patients with advanced EGFR-m lung cancer in the 1st line setting - i-RATE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040621
Enrollment
80
Registered
2022-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: C34- Malignant neoplasm of bronchus andlung

Interventions

Intervention1: Chemotherapy/TKI combination: Chemotherapy/TKI combination therapy with carboplatin (every 3 weeks) + pemetrexed (every 3 weeks) + Gefitinib (daily) until progression or unacceptable to

Sponsors

CMC Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient aged >= 18 years 2. Newly diagnosed advanced lung cancer (AJCC stage IIIB/ IVA/IVB) with sensitizing mutation in EGFR (exon 19 or exon 21) 3. Started on 1st line treatment with 1st generation EGFR TKIs 4. ECOG performance status 0, 1 or 2 5. â??High riskâ?? disease defined as: MAF non-clearers at 3-4 months (12-16 weeks) while on 1st gen TKI [OR] inadequate radiological response (ie) stable disease at 3-4 (12-16 weeks) months as per RECIST 1.1 6. Adequate bone marrow function with platelets > 100 X 109/l; WBC > 3 X 109/l; neutrophils > 1.5 X 109/l 7. Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance >50 ml/min. 8. Adequate hepatic function with serum total bilirubin 9. No concurrent uncontrolled medical conditions 10. No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix 11. Adequate contraceptive precautions if relevant 12. Ability to provide informed written consent 13. Controlled treated brain metastases

Exclusion criteria

Exclusion criteria: 1. Uncommon EGFR mutation (Exon 18/20) 2. Exon 19/21 mutant in combination with denovo T790M mutation 3. Patients started on1st line chemotherapy/TKI combination (or) osimertinib 4. Hypersensitivity to carboplatin or pemetrexed 5. Pregnancy or breastfeeding 6. Medical or psychiatric conditions that compromise the patients ability to give informed consent 7. Past history of interstitial lung disease 8. Participation in any investigational drug study in the previous four weeks

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS)Timepoint: Long term follow up for 5 years—

Secondary

MeasureTime frame
Overall survival (OS) PFS2 Quality of life (QoL) Response rates Toxicity profile Cost effectiveness analysis Mechanism of resistance- longitudinal plasma monitoring every 3-4 months in both arms for MAF clearance till disease progression Timepoint: Long term follow up upto 5 years Long term follow up upto 5 years Every 12 weeks; till disease progression Till disease progression Till disease progression End of treatment Every 3 months till disease progression—

Countries

India

Contacts

Public ContactAnjana Joel

Christian Medical College, Vellore

anjanajoel@gmail.com09994315798

Outcome results

None listed

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