A study to evaluate efficacy of thrice weekly osimertinib combined with chemotherapy in patients with EGFR Positive advanced Non small cell lung carcinoma
Phase 2
- Conditions
- Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
- Registration Number
- CTRI/2024/02/062382
- Lead Sponsor
- Ashish Singh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Metastatic non small cell carcinoma
2) EGFR mutation positive lung cancer
3) Performance status 0-1
Exclusion Criteria
1) Previously treated lung cancer
2) Unstable CNS metastasis
3) Concurrent other malignancies
4) Major cardiac condition
5) Inadequate bone marrow reserve
6) Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) at 9weeks after initiation of the study regimenTimepoint: Objective response rate (ORR) at 9weeks after initiation of the study regimen
- Secondary Outcome Measures
Name Time Method 1) Pharmacokinetics <br/ ><br>2) Time to Progression <br/ ><br>3) Adverse events with study regimenTimepoint: 1) Pharmacokinetics of thrice weekly osimertinib will be analyzed by measuring osimertinib blood levels drawn at 6 weeks & 9 weeks after initiation of study regimen. <br/ ><br>2) Time to progression: Tumor assessments of chest & abdomen will be performed at screening & after 9 weeks from initiation of treatment & then every 12 weeks until the occurrence of disease progression. <br/ ><br>3) Adverse events with study regimen will be recorded at 3weekly intervals.