A study to compare Gefitinib (Oral tablet) with gefitinib plus chemotherapy in Mutation positive lung cancer patients.

Phase 4

Conditions: Health Condition 1: null- The study subjects would consist of patients with advanced EGFR mutation-positive NSCLC who have received Gefitinib as first line treatment in palliative setting

Registration Number: CTRI/2018/05/013694

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients of either sex aged 18 years or older

2.Histologically or cytologically proven diagnosis of NSCLC other than predominantly squamous cell histology with an activating EGFR tyrosine kinase (TK) mutation

3.Performance Status 0-1

4.Progressive disease on first-line TKI

5.T790M mutation negative status.

6.Written informed consent prior to study treatment.

7.All patients should have achieved either a stable disease or objective response to the first line TKI and later develop disease progression.

8.Patients with Brain metastasis

Exclusion Criteria

1.Prior chemotherapy or other systemic anti-cancer treatment (excluding Gefitinib).

2.Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.

3.Neutrophils <1.5 x 109/L or platelets <100 x 109/L.

4.Serum bilirubin >1.5 x the upper limit of normal (ULN).

5.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN in the absence of liver metastases, or >5 x ULN in the presence of liver metastases.

6.Creatinine clearance <45 mL/min calculated by either Cockcroftâ??Gault or other validated methods.

7.Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) as judged by the investigator.

8.Other co-existing malignancies or malignancies diagnosed within the last 5 years (except non-melanoma skin cancer or in-situ cervical cancer).

9.Life expectancy of less than 3 months

10.Pregnant females

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)Timepoint: At progression & at the end of study

Secondary Outcome Measures

Name	Time	Method
1.Overall survival (OS) defined as the time from the date of randomisation until death due to any cause. <br/ ><br>2.Objective Response Rate (ORR) defined as per RECIST criteria <br/ ><br>3.Disease Control Rate (DCR) in each of the treatment arms <br/ ><br>4.Quality of Life - This will be measured by EORTC QOL Q-30 and LC13 <br/ ><br>5.Adverse Events and Toxicities will be recorded at each visit as per CTCAE 4.03 criteria <br/ ><br>Timepoint: 1. OS: at end of study <br/ ><br>2. ORR: At the time of progression <br/ ><br>3. DCR: At the time of progression <br/ ><br>4. QOL: at randomization and subsequently every 2to 3 months <br/ ><br>5. Toxicities: At every visit <br/ ><br>