Trial · NCT02679170
Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)
NCT02679170, Completed, Pfizer; results first posted 2024-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS). Trials, record NCT02679170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02679170
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)
- NCT number
- NCT02679170
- Status
- Completed
- Enrollment
- 692 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Crizotinib
- First posted
- 2016-02-10
- Last updated
- 2024-08-09
- Results first posted
- 2024-08-09
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure. |
| Primary | Number of Participants Classified According to the Origin of Tumor Sample | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) | Number of participants classified according to the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure. |
| Primary | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) | Number of participants classified according to the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure. |
| Primary | Number of Participants Classified According to Histological Subtype of Tumor | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease) | Number of participants classified according to the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified \[NOS\], other) were reported in this outcome measure. |
| Primary | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease) | Tumor Node Metastasis (TNM): based on tumor size, metastasis to nearby lymph nodes (LN), or distant metastasis. Stages were: stage IIIA (T0N2M0, T1N2M0,T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IV (any T any NM1), where T0 = early form of tumor, T1 = less than (\<) 2 centimeter (cm), T2 = 2-5 cm, T3 = greater than (\>) 5 cm, T4 = large sized, N0 = not spread to lymph nodes (LN), N1 = spread to 1 to 3 LN, N2 = spread to 4 to 9 LN, N3 = spread \>10 axillary LN, M0 = no metastasis, M1 = metastasis. The number of participants classified according to stages of tumor (Stage IIIA, IIIB and IV) were reported in this outcome measure. |
| Primary | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | Number of participants classified according to molecular alterations (PD-L1+: programmed death-ligand 1 positive, MET+: mesenchymal epithelial transition factor receptor positive, TP53+: tumor protein 53 positive, AKT: serine/threonine-protein kinase) in tumors were reported in this outcome measure. |
| Primary | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | Number of participants classified according to the location of metastases were reported in this outcome measure. One participant may have more than one site of metastases. |
| Primary | Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease) | Number of participants classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure. |
| Primary | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | Number of participants with treatment response as complete response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), partial response (PR): at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), progressive disease (PD): at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were reported in this outcome measure. |
| Primary | Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | The number of participants classified as dead or alive were reported in this outcome measure. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to the Origin of Tumor Sample | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Histological Subtype of Tumor | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease) | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease) | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group326
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ALK Treatment Sub-study | 0 | 35 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ROS1 Treatment Sub-study | 0 | 11 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ALK Treatment Sub-study | 1 | 43 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ROS1 Treatment Sub-study | 1 | 29 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ALK Treatment Sub-study | 2 | 2 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ROS1 Treatment Sub-study | 2 | 2 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ALK Treatment Sub-study | 3 | 1 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ROS1 Treatment Sub-study | 3 | 0 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ALK Treatment Sub-study | 4 | 0 | Participants | |
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ROS1 Treatment Sub-study | 4 | 0 | Participants |
1 to 10 of 326Source ClinicalTrials.gov
See all 326 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| ALK Incidence Sub-study | STARTED | ALK Incidence Sub-study | 572 | |
| ALK Incidence Sub-study | STARTED | ALK Treatment Sub-study | 0 | |
| ALK Incidence Sub-study | STARTED | ROS1 Treatment Sub-study | 0 | |
| ALK Incidence Sub-study | Full Analysis Set | ALK Incidence Sub-study | 559 | |
| ALK Incidence Sub-study | Full Analysis Set | ALK Treatment Sub-study | 0 | |
| ALK Incidence Sub-study | Full Analysis Set | ROS1 Treatment Sub-study | 0 | |
| ALK Incidence Sub-study | Safety Analysis Set | ALK Incidence Sub-study | 0 | |
| ALK Incidence Sub-study | Safety Analysis Set | ALK Treatment Sub-study | 0 | |
| ALK Incidence Sub-study | Safety Analysis Set | ROS1 Treatment Sub-study | 0 | |
| ALK Incidence Sub-study | COMPLETED | ALK Incidence Sub-study | 572 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events158
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Elevated alanine aminotransferase | Investigations | ALK Treatment Sub-study | 8 | 91 | |
| other | Elevated alanine aminotransferase | Investigations | ROS1 Treatment Sub-study | 7 | 50 | |
| other | Elevated amylase | Investigations | ALK Treatment Sub-study | 1 | 91 | |
| other | Elevated amylase | Investigations | ROS1 Treatment Sub-study | 0 | 50 | |
| other | Elevated aspartate aminotransferase | Investigations | ALK Treatment Sub-study | 6 | 91 | |
| other | Elevated aspartate aminotransferase | Investigations | ROS1 Treatment Sub-study | 7 | 50 | |
| other | Increased blood alkaline phosphatase | Investigations | ALK Treatment Sub-study | 1 | 91 | |
| other | Increased blood alkaline phosphatase | Investigations | ROS1 Treatment Sub-study | 0 | 50 | |
| other | Elevated Gamma glutamyl transferase | Investigations | ALK Treatment Sub-study | 1 | 91 | |
| other | Elevated Gamma glutamyl transferase | Investigations | ROS1 Treatment Sub-study | 0 | 50 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALK Treatment Sub-study | 38 | 91 |
| Total, all-cause mortality | ROS1 Treatment Sub-study | 25 | 50 |
| Total, other adverse events | ALK Treatment Sub-study | 54 | 91 |
| Total, other adverse events | ROS1 Treatment Sub-study | 33 | 50 |
| Total, serious adverse events | ALK Treatment Sub-study | 25 | 91 |
| Total, serious adverse events | ROS1 Treatment Sub-study | 9 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36162227 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ALK Treatment Sub-study vs ROS1 Treatment Sub-study: deaths from any cause | Trial comparisons |
| ALK Treatment Sub-study vs ROS1 Treatment Sub-study: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02679170
GET https://conductscience.org/api/trials/v1/NCT02679170/results?page=2