Metastatic Non Small Cell Lung Cancer Clinical Trial
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
Verified date | April 2024 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | November 8, 2022 |
Est. primary completion date | October 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC with EGFR activating mutations as detected by an appropriate test. 2. No prior treatment with systemic therapy and EGFR/Other Tyrosine Kinase Inhibitors (TKIs) for metastatic NSCLC. 3. Participants with asymptomatic Central Nervous System (CNS) metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible. 4. Age >=18 years. 5. ECOG PS of 0-2. 6. Adequate . hematologic, renal, liver function: ANC >= 1000/mm3; Platelets>=50000/mm3; Hb >=8 g/dL; est. Cr.Cl >=30 mL/min; Total serum bilirubin <1.5 × ULN; AST,ALT <=2.5 × ULN; (<=5.0 × ULN, if liver metastases). 7. Acute effects of any prior therapy resolved to baseline severity or to Common Terminology Criteria for Adverse Events (CTCAE) Grade <1 except for AEs that in the investigator's judgment do not constitute a safety risk for the participant. 8. Serum or urine pregnancy test (for females of childbearing potential) negative at Screening. Exclusion Criteria: 1. Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer. 2. Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation. 3. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Prior irradiation to >25% of the bone marrow. 4. Major surgery within 4 weeks prior to first dose of dacomitinib. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate wound healing. 5. Known prior or suspected severe hypersensitivity to dacomitinib or any component of its formulation. 6. History or known presence of interstitial fibrosis, interstitial lung disease, pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. 7. Other severe acute or chronic medical or psychiatric condition, that may interfere with the interpretation of study results and, would make the participant inappropriate for entry into this study. 8. Evidence of active malignancy (other than current NSCLC) within the last 3 years prior to first dose of dacomitinib. 9. Breastfeeding female participants. 10. Pregnant female participants; male participants able to father children and female participants of childbearing potential who are unwilling or unable to use contraception method per protocol |
Country | Name | City | State |
---|---|---|---|
India | Hemato Oncology Clinic Ahmedabad Pvt. Ltd | Ahmedabad | Gujarat |
India | The Gujarat Cancer and Research Institute | Ahmedabad | Gujarat |
India | Artemis hospital | Gurugram | Haryana |
India | Yashoda Hospital | Hyderabad | Telangana State |
India | Netaji Subhas Chandra Bose Cancer Hospital | Kolkata | WEST Bengal |
India | Tata Medical Center | Kolkata | WEST Bengal |
India | National Cancer Institute | Nagpur | Maharashtra |
India | Apex Wellness Hospital | Nashik | Maharashtra |
India | Rajiv Gandhi Cancer Institute And Research Centre | New Delhi | Delhi |
India | Grant Medical Foundation, Ruby Hall Clinic | Pune | Maharashtra |
India | Sahyadri Clinical Research and Development Center | Pune | Maharashtra |
India | Sahyadri Super Speciality Hospital | Pune | Maharashtra |
India | Gujarat Hospital - Gastro & Vascular Centre | Surat | Gujarat |
India | Unity Trauma Center And ICU (Unity Hospital ) | Surat | Gujarat |
India | Bhaktivedanta Hospital and Research Institute | Thane | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to approximately 107.3 weeks that were absent before treatment or that worsened relative to pretreatment state. | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks) | |
Secondary | Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, Progressive Disease. | From time of first dose until disease progression, death or initiation of a new anticancer therapy, whichever occurs first, assessed for up to 26 months | |
Secondary | Duration of Response (DOR) as Per RECIST Version 1.1 Based on Investigator Assessment | DOR: time from first documented occurrence of response (PR or CR) until date of first documented PD or death due to underlying cancer. RECIST 1.1. CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters. PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm^2. Unequivocal progression of existing non-target lesions. Appearance of new lesions. Participants with no PD and were still alive, were censored at last adequate tumor assessment. Kaplan-Meier method was used for DOR analysis. | From time of first tumor response until disease progression, death or initiation of a new anticancer therapy, whichever occurs first, assessed for up to 26 months |
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