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CTRI Number  CTRI/2025/07/090989 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Assess The Utility of Itraconazole in reducing the dose of OSIMERTINIB in NSCLC patients to reduce financial burden 
Scientific Title of Study   Phase I, Open-Label study to Assess Feasibility of CYP3A4 Inhibition on Reducing the Dosage of Osimertinib in EGFR mutant NSCLC to Reduce Financial Toxicity 
Trial Acronym  CAROL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pawan Kumar Singh 
Designation  Associate Professor 
Affiliation  Pandit B.D Sharma, PGIMS, Rohtak 
Address  Department of Pulmonary and Critical Care Medicine, PGIMS Rohatk

Rohtak
HARYANA
124001
India 
Phone  08437013094  
Fax    
Email  pawansingh.pgims@uhsr.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pawan Kumar Singh 
Designation  Associate Professor 
Affiliation  Pandit B.D Sharma, PGIMS, Rohtak 
Address  Department of Pulmonary and Critical Care Medicine, PGIMS Rohatk

Rohtak
HARYANA
124001
India 
Phone  08437013094  
Fax    
Email  pawansingh.pgims@uhsr.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Pawan Kumar Singh 
Designation  Associate Professor 
Affiliation  Pandit B.D Sharma, PGIMS, Rohtak 
Address  Department of Pulmonary and Critical Care Medicine, PGIMS Rohatk

Rohtak
HARYANA
124001
India 
Phone  08437013094  
Fax    
Email  pawansingh.pgims@uhsr.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of pulmonary and critical care medicine 
Address  PGIMS, Rohtak, Haryana, 124001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pawan Kumar Singh  Pandit.B.D.Sharma Post graduate institute of medical sciences, Rohtak  Thoracic Oncology Clinic, Department of Pulmonary and Critical Care Medicine, PGIMS Rohatk
Rohtak
HARYANA 		 08437013094

pawansingh.pgims@uhsr.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pandit.B.D.Sharma PGIMS/UHS,Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CYP3A4 Inhibition  Utility of Itraconazole at 200 mg twice daily to reduce dosage of osimertinib  
Comparator Agent  EGFR inhibitor  Osimertinib in NSCLC 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) pathologically confirmed advanced metastatic adenocarcinoma
2) No prior treatment with Itraconazole

 
 
ExclusionCriteria 
Details  1. Previous receipt of EGFR-TKI.
2. Untreated HIV, HBV, HCV infections.
3. Previous or co-existing malignancy
4. Pregnant or lactating women
5. Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol.
6. Any radiotherapy within 1 week of starting treatment on protocol.
7. Any major surgery within 4 weeks of starting treatment on protocol.
8. Any evidence of clinically significant interstitial lung disease
9. Known hypersensitivity to any component of Osimertinib or Itraconazole
10. Concomitant use of certain drugs due to serious or life-threatening interactions from CYP3A4 inhibition, such as antiarrhythmics, sedatives, sildenafil, antifungals etc
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the pharmacokinetic profile of Osimertinib (80mg and 40mg) when co-administered with Itraconazole in EGFR-positive NSCLC patients.   To determine the pharmacokinetic profile of Osimertinib (80mg and 40mg) when co-administered with Itraconazole in EGFR-positive NSCLC patients.  
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the safety and tolerability (using predefined drug-limiting toxicities) of Osimertinib-Itraconazole combination in EGFR-positive NSCLC patients.
2. To investigate the relationship between plasma Osimertinib concentrations and clinical efficacy, including tumor response, disease control rates, and progression-free survival
 		 1. Safety and tolerability: Incidence of all adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs). The incidence and severity of treatmentemergent adverse events (TEAEs) will be recorded according to CTCAE v5.0.
2. Cost-effectiveness: A cost-effectiveness analysis will be conducted to compare the different dosing regimens (80mg, 40mg, with and without Itraconazole).
3. Dose adjustments, including dose reduction, dose delay, or discontinuation due to drug-related toxicities.
4. Correlation between plasma Osimertinib concentrations and clinical outcomes (ORR, DCR, PFS). Evaluation of dose-response relationship for Osimertinib efficacy.
 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   To assess the feasibility of Osimertinib and Itraconazole combination in reducing the dose of osimertinib and thus reducing the financial toxicity of patients diagnosed to have EGRF mutant positive Non-small cell carcinoma. 
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