Trial Outcomes & Findings for Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa (NCT NCT02304406)
NCT ID: NCT02304406
Last Updated: 2019-07-19
Results Overview
Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).
COMPLETED
449 participants
3 years
2019-07-19
Participant Flow
Participant milestones
| Measure |
Non-Small Cell Lung Cancer
Tissue samples of participants of Middle East North Africa (MENA) previously diagnosed with non-small cell lung cancer (NSCLC) were tested retrospectively for the prevalence of anaplastic lymphoma kinase (ALK) rearrangement.
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|---|---|
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Overall Study
STARTED
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449
|
|
Overall Study
COMPLETED
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449
|
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Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa
Baseline characteristics by cohort
| Measure |
Non-Small Cell Lung Cancer
n=449 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
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|---|---|
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Age, Customized
18 to 65 years
|
272 Participants
n=5 Participants
|
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Age, Customized
Greater than equal to 65 years
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157 Participants
n=5 Participants
|
|
Age, Customized
Missing
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
308 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Arabic
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389 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White / Caucasian
|
54 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Full analysis set (FAS).
Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=449 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
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|---|---|
|
Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement
|
8.69 percentage of participants
Interval 6.26 to 11.71
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SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender
Male
|
10.1 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender
Female
|
5.7 percentage of participants
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SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the race of study participants.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race
Others
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0 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race
Missing
|
0 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race
White /Caucasian
|
11.1 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race
Arabic
|
8.5 percentage of participants
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SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the smoking history of study participants as participants who never smoked, current smoker and ex-smoker.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History
Never
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9.0 percentage of participants
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History
Current
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7.5 percentage of participants
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History
Ex-smoker
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5.8 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History
Unknown
|
11.9 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the diagnosis of tumor histology of study participants.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis
Not specified
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0 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis
Others
|
9.1 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis
Adenocarcinoma: Positive
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8.6 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis
Large cell carcinoma: Positive
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the tumor stage of study participants.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
Stage 1
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6.3 percentage of participants
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
Stage 2
|
7.8 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
Stage 3
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6.3 percentage of participants
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
Stage 3 A
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0 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
Stage 3 B
|
10.0 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
Stage 4
|
10.0 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
Missing
|
7.0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the treatment type of study participants.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type
Other
|
7.8 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type
Unknown
|
9.9 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type
Surgery with chemotherapy
|
7.5 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type
Surgery without chemotherapy
|
5.2 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type
Targeted therapy
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10.0 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type
Chemotherapy only
|
10.4 percentage of participants
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SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the PFS of study participants.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=150 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
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|---|---|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS)
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8.0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the line of therapy of study participants.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
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|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy
First-line
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9.1 percentage of participants
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy
Second-line
|
8.5 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy
Unknown
|
9.4 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy
Missing
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
Percentage of participants with best overall response. Complete response (CR) is equal to (=) disappearance of all target lesions. Partial Response (PR) = greater than equal to (\>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) \>= 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>= 1 new lesion. Stable disease (SD) =neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)
Missing
|
0 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)
CR
|
14.3 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)
PR
|
20.0 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)
PD
|
7.6 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)
SD
|
1.8 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)
Unknown
|
9.9 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure participant's status at the time of sampling were evaluable for treatment-naive and treated.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status
Treatment-naive
|
8.2 percentage of participants
|
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Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status
Treated
|
11.1 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status
Unknown
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure EGFR status of participants were evaluable for not tested, wild type and mutant.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status
Other
|
14.3 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status
Not tested
|
12.0 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status
Wild type
|
6.8 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status
Mutant
|
0 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status
Unknown
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.
In this outcome measure KRAS status of participants were evaluable for not tested, wild type, and mutant.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=448 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status
Not tested
|
9.0 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status
Wild type
|
0 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status
Mutant
|
0 percentage of participants
|
|
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status
Unknown
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Percent overall agreement between Vysis ALK-FISH and Ventana ALK IHC tests and its 95% CI is reported in this outcome measure.
Outcome measures
| Measure |
Non-Small Cell Lung Cancer
n=129 Participants
Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
|
|---|---|
|
Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection
|
98.45 percentage agreement
Interval 94.51 to 99.81
|
Adverse Events
Non-Small Cell Lung Cancer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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