Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
Conditions
Interventions
Intervention1: Chemotherapy and Cetuximab: Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles
Carboplatin area under the concentration-time curve 5
Sponsors
Christian Medical College, Vellore
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutation on tissue demonstrated by Next Generation Sequencing or Polymerase Chain Reaction 2. Measurable disease present according to RECIST v1.1 3. Adults more than 18 years of age with ECOG Performance status 0-1 4. Written informed consent obtained from the subject or the subjectâ??s legal representative and the ability of the subject to comply with the requirements of the study. 5. Required initial laboratory parameters: Haemoglobin more than or equal to 10g/dl, Absolute neutrophil count more than 1500/microL,Platelets more than 1 lakh per microL, ALT and AST less than or equal to 3 times upper limit of normal (ULN), Total bilirubin less than or equal to 1.5 x ULN (participants with Gilbertâ??s syndrome can enroll if conjugated bilirubin is within normal limits), Creatinine clearance more than 50 mL/min by Cockroft -Gault formula
Exclusion criteria
Exclusion criteria: 1. Any prior systemic treatment for locally advanced or metastatic lung cancer except for a. Symptomatic Patients who received cycle one chemotherapy with carboplatin and pemetrexed while awaiting molecular results b. Prior monotherapy with an approved EGFR TKI (gefitinib, erlotinib, afatinib, or Osimertinib) as non-standard first-line therapy for the treatment of locally advanced or metastatic disease is allowed if 1. treatment duration did not exceed eight weeks 2. lack of disease response was documented (radiographically) by an increase in tumor burden; 3. associated toxicities have resolved to baseline; and 4. the EGFR TKI has discontinued at least two weeks or four half-lives before enrolment, whichever is longer c. Prior adjuvant or neoadjuvant platinum-based doublet chemotherapy is allowed if completed at least 12 months prior 2. Synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins. 3. Symptomatic, untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least two weeks before enrolment is eligible) 4. History of leptomeningeal disease or spinal cord compression 5. Active malignancy (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. 6. Pregnant, breastfeeding, or unwilling to practice birth control during participation. 7. Major surgical procedure within 28 days of enrolment or anticipation of the need for major surgery during study other than that required for the cancer treatment. 8. Significant cardiovascular morbidity as below a. Diagnosis of deep vein thrombosis or pulmonary embolism within one month before or any of the following within six months prior: any acute coronary syndrome, stroke, transient ischemic attack, coronary/peripheral artery bypass graft b. Prolonged corrected QT interval by Fridericiaâ??s (QTcF) more than 480 msec, clinically significant cardiac arrhythmia, or electrophysiologic disease c. Uncontrolled (persistent) hypertension: systolic blood pressure more than 160 mm Hg; diastolic blood pressure more than 100 mm Hg d. Congestive heart failure is defined as New York Heart Association (NYHA) Class III/IV or hospitalization for congestive heart failure (any NYHA class) within the previous six months. e. Myocarditis/Pericarditis/clinically significant pericardial effusion f. Baseline left ventricular ejection fraction below the lower limit of normal as assessed by screening echocardiogram (ECHO) or multigated acquisition scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rates (ORR) following three months of planned systemic therapy assessed using RECIST v1.1 by a Thoracic RadiologistTimepoint: Baseline, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the safety profile of the planned systemic therapy, with adverse grades as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0Timepoint: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks | — |
Countries
India
Contacts
Public ContactAshish Singh
Christian Medical College, Vellore, India
Outcome results
None listed