Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations

NCT04511533 | Completed Phase 4 Results

• 1 other identifier: A7471064
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Metastatic Non Small Cell Lung Cancer

Keywords

Dacomitinib; Metastatic Non Small Cell Lung Cancer; EGFR-activating mutations; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment

  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

• Duration of Response (DOR) as Per RECIST Version 1.1 Based on Investigator Assessment

  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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Drug: Dacomitinib

Interventions

Dacomitinib DRUG

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.

Also known as: DACOPLICE

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC with EGFR activating mutations as detected by an appropriate test.
• No prior treatment with systemic therapy and EGFR/Other Tyrosine Kinase Inhibitors (TKIs) for metastatic NSCLC.
• 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.
• Age \>=18 years.
• ECOG PS of 0-2.
• 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).
• 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.
• Serum or urine pregnancy test (for females of childbearing potential) negative at Screening.

You may not qualify if:

• Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
• Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
• Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Prior irradiation to \>25% of the bone marrow.
• 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.
• Known prior or suspected severe hypersensitivity to dacomitinib or any component of its formulation.
• History or known presence of interstitial fibrosis, interstitial lung disease, pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis.
• 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.
• Evidence of active malignancy (other than current NSCLC) within the last 3 years prior to first dose of dacomitinib.
• Breastfeeding female participants.
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

The Gujarat Cancer and Research Institute

Ahmedabad, Gujarat, 380016, India

Location

Hemato Oncology Clinic Ahmedabad Pvt. Ltd

Ahmedabad, Gujarat, 380054, India

Location

Gujarat Hospital - Gastro & Vascular Centre

Surat, Gujarat, 395009, India

Location

Unity Trauma Center And ICU (Unity Hospital )

Surat, Gujarat, 395009, India

Location

Artemis hospital

Gurugram, Haryana, 122001, India

Location

National Cancer Institute

Nagpur, Maharashtra, 441108, India

Location

Apex Wellness Hospital

Nashik, Maharashtra, 422009, India

Location

Grant Medical Foundation, Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Sahyadri Clinical Research and Development Center

Pune, Maharashtra, 411004, India

Location

Sahyadri Super Speciality Hospital

Pune, Maharashtra, 411004, India

Location

Bhaktivedanta Hospital and Research Institute

Thane, Maharashtra, 401107, India

Location

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Yashoda Hospital

Hyderabad, Telangana State, 500082, India

Location

Netaji Subhas Chandra Bose Cancer Hospital

Kolkata, West Bengal, 700094, India

Location

Tata Medical Center

Kolkata, West Bengal, 700160, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 13, 2020
• Study Start: August 27, 2020
• Primary Completion: October 15, 2022
• Study Completion: November 8, 2022
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (15)