Trial Outcomes & Findings for Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer (NCT NCT02965378)

Last Updated: 2021-05-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

43 participants

Primary outcome timeframe

From date of registration to maximum of 2 years and 4 months or death.

Results posted on

2021-05-27

Participant Flow

33 participants were enrolled to AZD4547 arm and 10 to Docetaxel. 8 participants on AZD4547 and 1 participant on docetaxel were ineligible. 2 participants on Docetaxel were re-registered to AZD4547 after progression on Docetaxel, and for analysis, were combined with participants on arm 1 (AZD4547). Thus 27 participants were analyzed for AZD4547.

Participant milestones

Participant milestones
Measure	AZD4547 Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies	Docetaxel Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to AZD4547. Docetaxel Given IV Other Names: * Docecad * Docetaxel * RP56976 * Taxotere * Taxotere Injection Concentrate Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	25	9
Overall Study Participants on Docetaxel Re-registered to AZD4547 After Progression.	0	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	25	9

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD4547 Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies	Docetaxel Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to AZD4547. Docetaxel Given IV Other Names: * Docecad * Docetaxel * RP56976 * Taxotere * Taxotere Injection Concentrate Laboratory Biomarker Analysis: Correlative studies
Overall Study Progression	16	4
Overall Study Adverse Event	5	2
Overall Study Death	2	0
Overall Study Refusal	2	1
Overall Study Not protocol specified	0	2

Baseline Characteristics

Docetaxel arm closed before data were collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD4547 n=25 Participants Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies	Docetaxel n=9 Participants Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to AZD4547. Docetaxel Given IV Other Names: * Docecad * Docetaxel * RP56976 * Taxotere * Taxotere Injection Concentrate Laboratory Biomarker Analysis: Correlative studies	Total n=34 Participants Total of all reporting groups
Age, Continuous	66.3 years n=25 Participants	60.4 years n=9 Participants	66.2 years n=34 Participants
Sex: Female, Male Female	6 Participants n=25 Participants	4 Participants n=9 Participants	10 Participants n=34 Participants
Sex: Female, Male Male	19 Participants n=25 Participants	5 Participants n=9 Participants	24 Participants n=34 Participants
Race/Ethnicity, Customized Black	3 Participants n=25 Participants	1 Participants n=9 Participants	4 Participants n=34 Participants
Race/Ethnicity, Customized White	22 Participants n=25 Participants	8 Participants n=9 Participants	30 Participants n=34 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=25 Participants	0 Participants n=9 Participants	2 Participants n=34 Participants
Performance status 0	3 Participants n=25 Participants	3 Participants n=9 Participants	6 Participants n=34 Participants
Performance status 1	22 Participants n=25 Participants	5 Participants n=9 Participants	27 Participants n=34 Participants
Performance status 2	0 Participants n=25 Participants	1 Participants n=9 Participants	1 Participants n=34 Participants
Number of prior lines of therapy for stage IV disease 0	2 Participants n=25 Participants • Docetaxel arm closed before data were collected	—	2 Participants n=25 Participants • Docetaxel arm closed before data were collected
Number of prior lines of therapy for stage IV disease 1	20 Participants n=25 Participants • Docetaxel arm closed before data were collected	—	20 Participants n=25 Participants • Docetaxel arm closed before data were collected
Number of prior lines of therapy for stage IV disease 2 or more	3 Participants n=25 Participants • Docetaxel arm closed before data were collected	—	3 Participants n=25 Participants • Docetaxel arm closed before data were collected
Smoking status Current smoker	10 Participants n=25 Participants	4 Participants n=9 Participants	14 Participants n=34 Participants
Smoking status Former smoker	15 Participants n=25 Participants	5 Participants n=9 Participants	20 Participants n=34 Participants
Smoking status Never smoker	0 Participants n=25 Participants	0 Participants n=9 Participants	0 Participants n=34 Participants

PRIMARY outcome

Timeframe: From date of registration to maximum of 2 years and 4 months or death.

Population: Eligible and evaluable participants

Outcome measures

Outcome measures
Measure	Arm I - AZD4547 n=27 Participants Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies
Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial)	7 percentage of participants Interval 0.0 to 17.0

SECONDARY outcome

Timeframe: From date of registration to maximum of 2 years and 4 months or death.

Population: Eligible and evaluable participants that achieved complete response or partial response.

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

Outcome measures

Outcome measures
Measure	Arm I - AZD4547 n=2 Participants Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies
Duration of Response Among Patients Who Achieve a Complete Response or Partial Response by Response Evaluation Criteria in Solid Tumors 1.1	2.2 months Interval 1.5 to 2.9

SECONDARY outcome

Timeframe: From date of registration to maximum of 2 years and 4 months or death

Population: Eligible and evaluable participants

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

Outcome measures

Outcome measures
Measure	Arm I - AZD4547 n=27 Participants Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Survival	7.5 months Interval 3.7 to 9.3

SECONDARY outcome

Timeframe: From date of registration to maximum of 2 years and 4 months or death.

Population: Eligible and evaluable participants

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

Outcome measures

Outcome measures
Measure	Arm I - AZD4547 n=27 Participants Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies
Progression-free Survival	2.7 months Interval 1.4 to 4.5

SECONDARY outcome

Timeframe: Duration of treatment and follow up, up to 2 years and 4 months post registration or death.

Population: Participants who received at least one dose of AZD4547 treatment.

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

Outcome measures

Outcome measures
Measure	Arm I - AZD4547 n=27 Participants Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lung infection	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis oral	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophil count decreased	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Retinopathy	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Sepsis	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dyspnea	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Febrile neutropenia	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyponatremia	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Will be monitored by the percentage of screened patients that register to a therapeutic sub-study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

AZD4547

Serious events: 7 serious events

Other events: 27 other events

Deaths: 25 deaths

Docetaxel

Serious events: 1 serious events

Other events: 9 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	AZD4547 n=27 participants at risk Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies	Docetaxel n=9 participants at risk Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, participants may be eligible to re-register to AZD4547. Docetaxel: Given IV Other Names: Docecad Docetaxel RP56976 Taxotere Taxotere Injection Concentrate Laboratory Biomarker Analysis: Correlative studies
Blood and lymphatic system disorders Anemia	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Cardiac disorders Cardiac arrest	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Dysphagia	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Esophageal fistula	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Pain	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Bronchial infection	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Lung infection	7.4% 2/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Sepsis	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Injury, poisoning and procedural complications Tracheal hemorrhage	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	11.1% 1/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Syncope	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 1/27 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	11.1% 1/9 • Duration of treatment and follow up, up to 2 years and 4 months post registration or death. 34 participants were assessed for AEs: 27 on AZD4547 and 9 on docetaxel arm. 2 participants that were re-registered from the docetaxel arm to receive AZD4547 after progression were assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0

Other adverse events

Additional Information

Lung Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place