Clinical trial NCT04511533: Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Non Small Cell Lung Cancer
Keywords: Dacomitinib
Metastatic Non Small Cell Lung Cancer
EGFR-activating mutations
NSCLC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

STUDY PROCEDURES:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 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:
measure: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment
timeFrame: 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
measure: Duration of Response (DOR) as Per RECIST Version 1.1 Based on Investigator Assessment
timeFrame: 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
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre
state: Delhi
city: Ahmedabad
country: India
facility: The Gujarat Cancer and Research Institute
state: Gujarat
city: Ahmedabad
country: India
facility: Hemato Oncology Clinic Ahmedabad Pvt. Ltd
state: Gujarat
city: Surat
country: India
facility: Gujarat Hospital - Gastro & Vascular Centre
state: Gujarat
city: Surat
country: India
facility: Unity Trauma Center And ICU (Unity Hospital )
state: Gujarat
city: Gurugram
country: India
facility: Artemis hospital
state: Haryana
city: Nagpur
country: India
facility: National Cancer Institute
state: Maharashtra
city: Nashik
country: India
facility: Apex Wellness Hospital
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation, Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Clinical Research and Development Center
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Thane
country: India
facility: Bhaktivedanta Hospital and Research Institute
state: Maharashtra
city: Hyderabad
country: India
facility: Yashoda Hospital
state: Telangana State
city: Kolkata
country: India
facility: Netaji Subhas Chandra Bose Cancer Hospital
state: WEST Bengal
city: Kolkata
country: India
facility: Tata Medical Center
state: WEST Bengal
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: