Trial · NCT02965378
Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer
NCT02965378, Phase 2, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2021-05-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer. Trials, record NCT02965378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02965378
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer
- NCT number
- NCT02965378
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 43 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
FGFR1 Gene Amplification, FGFR1 Gene Mutation, FGFR2 Gene Amplification, FGFR2 Gene Mutation, FGFR3 Gene Amplification, FGFR3 Gene Mutation, Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7
- Interventions
- Docetaxel, FGFR Inhibitor AZD4547, Laboratory Biomarker Analysis
- First posted
- 2016-11-16
- Last updated
- 2021-05-27
- Results first posted
- 2021-05-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial) | From date of registration to maximum of 2 years and 4 months or death. | The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with AZD4547 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. It was pre-specified that only the AZD4547 arm would be analyzed due to removal of docetaxel as standard of care treatment |
| Secondary | Duration of Response Among Patients Who Achieve a Complete Response or Partial Response by Response Evaluation Criteria in Solid Tumors 1.1 | From date of registration to maximum of 2 years and 4 months or death. | From date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review, or symptomatic deterioration or death due to any cause among patients who achieve complete or partial response per RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. It was pre-specified that only the AZD4547 arm would be analyzed due to removal of docetaxel as standard of care treatment |
| Secondary | Overall Survival | From date of registration to maximum of 2 years and 4 months or death | From date of sub-study registration on study until death from any cause. Observations for participants last known to be alive were censored. It was pre-specified that only the AZD4547 arm would be analyzed due to removal of docetaxel as standard of care treatment |
| Secondary | Progression-free Survival | From date of registration to maximum of 2 years and 4 months or death. | From date of sub-study registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. It was pre-specified that only the AZD4547 arm would be analyzed due to removal of docetaxel as standard of care treatment |
| Secondary | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up, up to 2 years and 4 months post registration or death. | Adverse Events (AEs) are reported per CTCAE Version 5.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. It was pre-specified that only the AZD4547 arm would be analyzed due to removal of docetaxel as standard of care treatment |
| Other | Screen Success Rate | Up to 3 years | Will be monitored by the percentage of screened patients that register to a therapeutic sub-study. |
| Other | Treatment Arm Randomization Acceptance Rate | Up to 3 years | Will be monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to receive. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial) | From date of registration to maximum of 2 years and 4 months or death. | Eligible and evaluable participants | percentage of participants | NUMBER |
| SECONDARY | Duration of Response Among Patients Who Achieve a Complete Response or Partial Response by Response Evaluation Criteria in Solid Tumors 1.1 | From date of registration to maximum of 2 years and 4 months or death. | Eligible and evaluable participants that achieved complete response or partial response. | months | MEAN |
| SECONDARY | Overall Survival | From date of registration to maximum of 2 years and 4 months or death | Eligible and evaluable participants | months | MEDIAN |
| SECONDARY | Progression-free Survival | From date of registration to maximum of 2 years and 4 months or death. | Eligible and evaluable participants | months | MEDIAN |
| SECONDARY | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up, up to 2 years and 4 months post registration or death. | Participants who received at least one dose of AZD4547 treatment. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Screen Success Rate | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Treatment Arm Randomization Acceptance Rate | Up to 3 years |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial) | Arm I - AZD4547 | 7 | 95% Confidence Interval 0 to 17 | percentage of participants | |
| Duration of Response Among Patients Who Achieve a Complete Response or Partial Response by Response Evaluation Criteria in Solid Tumors 1.1 | Arm I - AZD4547 | 2.2 | Full Range 1.5 to 2.9 | months | |
| Overall Survival | Arm I - AZD4547 | 7.5 | 95% Confidence Interval 3.7 to 9.3 | months | |
| Progression-free Survival | Arm I - AZD4547 | 2.7 | 95% Confidence Interval 1.4 to 4.5 | months | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | AZD4547 | Dyspnea | 1 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | AZD4547 | Fatigue | 1 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | AZD4547 | Febrile neutropenia | 1 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | AZD4547 | Hyponatremia | 1 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | AZD4547 | Lung infection | 1 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | AZD4547 | Lymphocyte count decreased | 1 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD4547 | 25 | |
| Overall Study | STARTED | Docetaxel | 9 | |
| Overall Study | Participants on Docetaxel Re-registered to AZD4547 After Progression. | AZD4547 | 0 | |
| Overall Study | Participants on Docetaxel Re-registered to AZD4547 After Progression. | Docetaxel | 2 | |
| Overall Study | COMPLETED | AZD4547 | 0 | |
| Overall Study | COMPLETED | Docetaxel | 0 | |
| Overall Study | NOT COMPLETED | AZD4547 | 25 | |
| Overall Study | NOT COMPLETED | Docetaxel | 9 |
Source ClinicalTrials.gov
Adverse events322
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 | Anemia | Blood and lymphatic system disorders | AZD4547 | 7 | 27 | |
| other | Anemia | Blood and lymphatic system disorders | Docetaxel | 7 | 9 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | AZD4547 | 0 | 27 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Docetaxel | 3 | 9 | |
| other | Cardiac disorders-Other | Cardiac disorders | AZD4547 | 0 | 27 | |
| other | Cardiac disorders-Other | Cardiac disorders | Docetaxel | 1 | 9 | |
| other | Heart failure | Cardiac disorders | AZD4547 | 0 | 27 | |
| other | Heart failure | Cardiac disorders | Docetaxel | 1 | 9 | |
| other | Myocardial infarction | Cardiac disorders | AZD4547 | 0 | 27 | |
| other | Myocardial infarction | Cardiac disorders | Docetaxel | 1 | 9 |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD4547 | 25 | 27 |
| Total, all-cause mortality | Docetaxel | 9 | 9 |
| Total, other adverse events | AZD4547 | 27 | 27 |
| Total, other adverse events | Docetaxel | 9 | 9 |
| Total, serious adverse events | AZD4547 | 7 | 27 |
| Total, serious adverse events | Docetaxel | 1 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AZD4547 vs Docetaxel: deaths from any cause | Trial comparisons |
| AZD4547 vs Docetaxel: 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/NCT02965378
GET https://conductscience.org/api/trials/v1/NCT02965378/events?page=2