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 mutatio

Phase 2

Conditions: Health Condition 1: C34- Malignant neoplasm of bronchus andlung

Registration Number: CTRI/2022/02/040621

Lead Sponsor: CMC Vellore

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 < 1.5 X upper limit of normal range.

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)Timepoint: Long term follow up for 5 years

Secondary Outcome Measures

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