Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations
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|ClinicalTrials.gov Identifier: NCT04511533|
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non Small Cell Lung Cancer||Drug: Dacomitinib||Phase 4|
This is a Phase 4, open label, single arm, multi-center, prospective clinical trial of dacomitinib that will be performed in India. This study will enroll a sufficient number of participants to ensure that 100 participants are treated with dacomitinib. The primary objective of this study is to assess the safety and tolerability of dacomitinib. The secondary objective is to evaluate antitumor activity of dacomitinib by objective response rate and duration of response. Drug administration: Dacomitinib will be supplied by Pfizer and administered in accordance with the India Local Product Document (LPD). The recommended dosage of dacomitinib is 45 mg taken orally once a day at approximately the same time each day, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurs.
Screening: Participants will be screened within 28 days prior to first dosing of dacomitinib to confirm that they meet the eligibility criteria for the study.
Follow-up Visit: All participants will return to the study site up to 28 days after the last dose of study drug administration for assessment of potential AEs, recording of concomitant treatment use and to confirm appropriate contraception usage.
ASSESSMENTS Tumor Assessments: Tumor assessments will include all known or suspected disease sites. Computerized tomography (CT) or Magnetic resonance imaging (MRI) scans of Chest Abdomen and Pelvis and MRI of the brain will be performed at Screening and repeated every 12 weeks ±1 week until the end of treatment. For all tumor assessments, the method of assessment that was used at Screening will be used throughout the study. Tumor assessment will be repeated at the end of treatment if more than 6 weeks have passed since the last evaluation. Assessment of response will be made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmation of response will be required ≥4 weeks after initial response is observed.
Safety Assessments: The following parameters will be assessed - Physical examination, vital signs, Eastern Cooperative Oncology Group Performance score (ECOG PS), safety lab data, 12 lead electrocardiogram (ECG). Unscheduled clinical laboratory measurements may be obtained at any time during the study to assess any perceived safety concerns.
Adverse event reporting: All observed or volunteered AEs regardless of treatment group or suspected causal relationship to the investigational product(s) will be reported as per regulatory requirements.
End of Study: The end of study is defined as 1 year after the last participant first visit (LPFV) date in the study. At the end of study, participants who are on treatment and benefiting from dacomitinib treatment will be switched to commercially available dacomitinib if considered appropriate by the investigator, as soon as feasible.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SINGLE ARM STUDY TO EVALUATE THE SAFETY OF DACOMITINIB FOR THE FIRST-LINE TREATMENT OF PARTICIPANTS IN INDIA WITH METASTATIC NON-SMALL CELL LUNG CANCER WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR)-ACTIVATING MUTATIONS|
|Actual Study Start Date :||August 27, 2020|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||August 1, 2023|
Experimental: Treatment Arm
The recommended dosage of dacomitinib is 45 mg taken orally once a day at approximately the same time each day, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurs.
Dacomitinib is a kinase inhibitor indicated for the first line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.
Other Name: DACOPLICE
- Incidence of Adverse events (AEs) [ Time Frame: From the time of first dose to 28 days post last dosing date or the date of initiation of a new anticancer therapy, whichever occurs first ]The incidence of adverse events will be assessed for all participants who receive at least one dose of dacomitinib, regardless of dosing interruptions or dosing compliance.
- Confirmed Objective Response Rate (ORR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 [ Time Frame: From time of first dose until disease progression, death or initiation of a new anticancer therapy, whichever occurs first, assessed for up to 3 years ]The secondary outcome measure is the treatment effect of dacomitinib as assessed by the investigator for all participants who receive at least one dose of dacomitinib without regard to tolerability or discontinuation from treatment.
- Confirmed Duration of Response (DoR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 [ Time Frame: From time of first tumor response until disease progression, death or initiation of a new anticancer therapy, whichever occurs first, assessed for up to 3 years ]The secondary outcome measure is the treatment effect of dacomitinib as assessed by the investigator for all participants who receive at least one dose of dacomitinib without regard to tolerability or discontinuation from treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511533
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Rajiv Gandhi Cancer Institute And Research Centre||Recruiting|
|New Delhi, Delhi, India, 110085|
|The Gujarat Cancer and Research Institute||Recruiting|
|Ahmedabad, Gujarat, India, 380016|
|Hemato Oncology Clinic Ahmedabad Pvt. Ltd||Not yet recruiting|
|Ahmedabad, Gujarat, India, 380054|
|Gurugram, Haryana, India, 122001|
|National Cancer Institute||Recruiting|
|Nagpur, Maharashtra, India, 441108|
|Apex Wellness Hospital||Recruiting|
|Nashik, Maharashtra, India, 422009|
|Sahyadri Super Speciality Hospital||Recruiting|
|Pune, Maharashtra, India, 41004|
|Grant Medical Foundation, Ruby Hall Clinic||Recruiting|
|Pune, Maharashtra, India, 411001|
|Bhaktivedanta Hospital and Research Institute||Recruiting|
|Thane, Maharashtra, India, 401107|
|Yashoda Hospital||Not yet recruiting|
|Hyderabad, Telangana State, India, 500082|
|Tata Medical Center||Recruiting|
|Kolkata, WEST Bengal, India, 700160|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|