Dacomitinib in Lung Cancer With Uncommon EGFR Mutations
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|ClinicalTrials.gov Identifier: NCT04504071|
Recruitment Status : Not yet recruiting
First Posted : August 7, 2020
Last Update Posted : August 7, 2020
This is a single center and exploratory study, aiming to analyze the efficacy and safety of dacomitinib-a pan-HER and irreversible TKI in subjects with diagnosed stage IIIB/IV or recurrent NSCLC. All subjects will have tumors that test positive for at least one uncommon EGFR activating mutation (do not have drug-resistant pattern, e.g. 20 insertion or 20T790M). All patients will be of histo- and/or cytopathology confirmed. Determination of the EGFR mutation type will be performed in the pathological department of Shanghai Chest Hospital. Both ARMS method or targeted sequencing are acceptable. It is not acceptable for subjects with the presence of the exon 20T790M mutation or insertion together with either EGFR activating mutations (exon 19 deletion or the L858R mutation in exon 21) or uncommon EGFR mutations. 10ml peripheral blood must be available for concomitant study. All eligible subjects must have adequate renal, hepatic, and hematologic function, as defined in "inclusion criteria".
Patients will receive continuous oral therapy with the study drugs (dacomitinib 45 mg) until progressive disease as defined by RECIST version 1.1 or judged by investigator that the patient no longer derives clinical benefit from study treatment. At the time of progression and removal from study treatment, the subject may receive any regulatory approved therapy at the judgment of the investigator. Timely and complete disease assessments in this study are important. Every effort should be made to ensure disease assessments performed as scheduled to prevent the introduction of bias into the assessment of efficacy. Failure to perform any of the required disease assessments will result in the inability to determine disease status for that time point. Frequent off schedule or incomplete disease assessments have the potential to weaken the study conclusion.
Subjects who have progressive disease per RECIST version 1.1 confirmed by the investigator believes it is in their best interest to continue on their study therapy, will be allowed to continue on their therapy with or without local therapy (e.g. surgical removal and/or radiation of a single lesion), at the discretion of the investigator until any alternate or additional systemic anti-cancer therapy regimen is implemented. The subsequent new cancer therapy (including, for systemic therapy, drugs administered, date of initiation and discontinuation of each drug) and OS will be recorded. Each subject will be followed for survival status and subsequent cancer therapies up to 48 months from the date of first dosing. This data may be collected from subjects by telephone, and if collected should be entered into the CRF.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Metastatic EGF-R Positive Non-Small Cell Lung Cancer||Drug: Dacomitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dacomitinib in Advanced Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutations: A Single Center and Exploratory Study|
|Estimated Study Start Date :||November 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||December 2022|
This is a single arm study.
Patients will receive continuous oral therapy with the study drugs (dacomitinib 45 mg) until disease progression or unacceptable toxicity.
- Objective response rate （ORR） [ Time Frame: 6-12 weeks ]ORR was defined as the proportion of patients with a complete response (CR) or partial response (PR) per the investigator's assessment using RECIST 1.1 criteria
- Disease control rate [ Time Frame: 6-12 weeks ]The disease control rate (DCR) was defined as the sum of the proportions of patients who had CR, PR, and stable disease (SD) using RECIST 1.1 criteria
- PFS [ Time Frame: 13-15months ]PFS was defined as the time from study treatment initiation to the first occurrence of documented disease progression or death from any cause during the study, whichever occurred first.
- Overall survival [ Time Frame: 22-25months ]OS was defined as the time from the first dose of study treatment to the time of death from any cause during the study.
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): NCT04504071
|Shanghai Chest hospital|
|Shanghai, Shanghai, China, 200030|