Trial Outcomes & Findings for Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations (NCT NCT04511533)
NCT ID: NCT04511533
Last Updated: 2024-04-05
Results Overview
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.
COMPLETED
PHASE4
101 participants
From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
2024-04-05
Participant Flow
A total of 106 participants were screened, 5 participants were screen failures, 101 participants were enrolled and assigned to treatment and all of them were treated.
Participant milestones
| Measure |
Dacomitinib
Participants with metastatic non-small cell lung carcinoma (NSCLC) with epidermal growth factor receptor (EGFR) mutations received a starting dose of dacomitinib 45 mg once daily in each cycle of 28 days, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurred. The maximum treatment duration was approximately 107.3 weeks.
|
|---|---|
|
Treatment
STARTED
|
101
|
|
Treatment
COMPLETED
|
21
|
|
Treatment
NOT COMPLETED
|
80
|
|
Follow-Up
STARTED
|
96
|
|
Follow-Up
COMPLETED
|
78
|
|
Follow-Up
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Dacomitinib
Participants with metastatic non-small cell lung carcinoma (NSCLC) with epidermal growth factor receptor (EGFR) mutations received a starting dose of dacomitinib 45 mg once daily in each cycle of 28 days, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurred. The maximum treatment duration was approximately 107.3 weeks.
|
|---|---|
|
Treatment
Other
|
2
|
|
Treatment
Withdrawal by Subject
|
11
|
|
Treatment
Death
|
5
|
|
Treatment
Physician Decision
|
1
|
|
Treatment
Progressive Disease
|
61
|
|
Follow-Up
Other
|
7
|
|
Follow-Up
Withdrawal by Subject
|
5
|
|
Follow-Up
Lost to Follow-up
|
2
|
|
Follow-Up
Death
|
4
|
Baseline Characteristics
Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations
Baseline characteristics by cohort
| Measure |
Dacomitinib
n=101 Participants
Participants with metastatic non-small cell lung carcinoma (NSCLC) with epidermal growth factor receptor (EGFR) mutations received a starting dose of dacomitinib 45 mg once daily in each cycle of 28 days, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurred. The maximum treatment duration was approximately 107.3 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
55.95 Years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
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)Population: All participants who received at least 1 dose of dacomitinib.
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.
Outcome measures
| Measure |
Dacomitinib
n=101 Participants
Participants with metastatic non-small cell lung carcinoma (NSCLC) with epidermal growth factor receptor (EGFR) mutations received a starting dose of dacomitinib 45 mg once daily in each cycle of 28 days, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurred. The maximum treatment duration was approximately 107.3 weeks.
|
|---|---|
|
Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with treatment-related SAEs
|
7 Participants
|
|
Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with all-causality TEAEs
|
94 Participants
|
|
Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with all-causality SAEs
|
16 Participants
|
|
Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with treatment-related TEAEs
|
92 Participants
|
SECONDARY outcome
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 monthsPopulation: All participants who received at least 1 dose of dacomitinib.
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.
Outcome measures
| Measure |
Dacomitinib
n=101 Participants
Participants with metastatic non-small cell lung carcinoma (NSCLC) with epidermal growth factor receptor (EGFR) mutations received a starting dose of dacomitinib 45 mg once daily in each cycle of 28 days, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurred. The maximum treatment duration was approximately 107.3 weeks.
|
|---|---|
|
Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment
|
50.5 Percentage of participants
Interval 40.9 to 60.0
|
SECONDARY outcome
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 monthsPopulation: All participants who received at least 1 dose of dacomitinib. DOR was only for the subset participants with an objective response.
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.
Outcome measures
| Measure |
Dacomitinib
n=51 Participants
Participants with metastatic non-small cell lung carcinoma (NSCLC) with epidermal growth factor receptor (EGFR) mutations received a starting dose of dacomitinib 45 mg once daily in each cycle of 28 days, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurred. The maximum treatment duration was approximately 107.3 weeks.
|
|---|---|
|
Duration of Response (DOR) as Per RECIST Version 1.1 Based on Investigator Assessment
|
11.1 Months
Interval 8.3 to 16.6
|
Adverse Events
Dacomitinib
Serious adverse events
| Measure |
Dacomitinib
n=101 participants at risk
Participants with metastatic non-small cell lung carcinoma (NSCLC) with epidermal growth factor receptor (EGFR) mutations received a starting dose of dacomitinib 45 mg once daily in each cycle of 28 days, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurred. The maximum treatment duration was approximately 107.3 weeks.
|
|---|---|
|
General disorders
Asthenia
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
General disorders
Death
|
2.0%
2/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
General disorders
Disease progression
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
General disorders
Fatigue
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
General disorders
Pyrexia
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Infections and infestations
COVID-19
|
2.0%
2/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Infections and infestations
Pneumonia viral
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Infections and infestations
Sepsis
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
3/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
3/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Cardiac disorders
Cardiac arrest
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Investigations
Blood creatinine increased
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Investigations
SARS-CoV-2 test positive
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.99%
1/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
Other adverse events
| Measure |
Dacomitinib
n=101 participants at risk
Participants with metastatic non-small cell lung carcinoma (NSCLC) with epidermal growth factor receptor (EGFR) mutations received a starting dose of dacomitinib 45 mg once daily in each cycle of 28 days, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurred. The maximum treatment duration was approximately 107.3 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.9%
9/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
51.5%
52/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.9%
8/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Gastrointestinal disorders
Nausea
|
6.9%
7/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Gastrointestinal disorders
Stomatitis
|
10.9%
11/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
6/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
General disorders
Asthenia
|
6.9%
7/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
General disorders
Chest pain
|
6.9%
7/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
General disorders
Mucosal inflammation
|
10.9%
11/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
General disorders
Pyrexia
|
7.9%
8/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Infections and infestations
Paronychia
|
25.7%
26/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Investigations
Weight decreased
|
34.7%
35/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.9%
10/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
6/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
8/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.9%
11/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.9%
8/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
24.8%
25/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
7/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.6%
43/101 • From the first dose of study treatment up to a minimum of 28 days after the last dose of study treatment (maximum treatment duration: 107.3 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER