Trial Outcomes & Findings for Lung-MAP: Taselisib as Therapy in Treating Patients With Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches (NCT NCT02785913)
NCT ID: NCT02785913
Last Updated: 2020-10-23
Results Overview
ORR-the percentage of PI3K GNE-positive participants with confirmed and unconfirmed, partial response and complete response to treatment with GDC-0032 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
From date of registration to maximum of 3 years.
Results posted on
2020-10-23
Participant Flow
31 participants were enrolled. However, 4 were deemed ineligible and 1 died prior to receiving study treatment. Thus 26 participants were eligible. Of these, 21 were PI3K GNE-positive (had at least one mutation that was possibly associated with clinical benefit of PI3K inhibitors), and were included in the primary analysis population (PAP).
Participant milestones
| Measure |
Arm I (GDC-0032)
Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Arm I (GDC-0032)
Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
2
|
|
Overall Study
Progression
|
18
|
|
Overall Study
Not protocol specified
|
1
|
Baseline Characteristics
Lung-MAP: Taselisib as Therapy in Treating Patients With Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches
Baseline characteristics by cohort
| Measure |
Arm I (GDC-0032)
n=26 Participants
Patients receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
Age, Continuous
|
68.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
PI3K GNE-Positive
|
21 Participants
n=5 Participants
|
|
Performance Status
0
|
7 Participants
n=5 Participants
|
|
Performance Status
1
|
18 Participants
n=5 Participants
|
|
Performance Status
2
|
1 Participants
n=5 Participants
|
|
Smoking History
Current Smoker
|
8 Participants
n=5 Participants
|
|
Smoking History
Former Smoker
|
17 Participants
n=5 Participants
|
|
Smoking History
Never Smoker
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of registration to maximum of 3 years.Population: PI3K GNE-positive participants only.
ORR-the percentage of PI3K GNE-positive participants with confirmed and unconfirmed, partial response and complete response to treatment with GDC-0032 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Outcome measures
| Measure |
Arm I (GDC-0032)
n=21 Participants
Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
Objective Response Rate (ORR) for PI3K GNE-positive Participants Registered to S1400B Treated With GDC-0032.
Confirmed Partial Response
|
1 Participants
|
|
Objective Response Rate (ORR) for PI3K GNE-positive Participants Registered to S1400B Treated With GDC-0032.
Stable/No Response
|
13 Participants
|
|
Objective Response Rate (ORR) for PI3K GNE-positive Participants Registered to S1400B Treated With GDC-0032.
Progression
|
5 Participants
|
|
Objective Response Rate (ORR) for PI3K GNE-positive Participants Registered to S1400B Treated With GDC-0032.
Early Death
|
1 Participants
|
|
Objective Response Rate (ORR) for PI3K GNE-positive Participants Registered to S1400B Treated With GDC-0032.
Assessment Inadequate
|
1 Participants
|
SECONDARY outcome
Timeframe: From time of registration to maximum of 3 years.Population: PI3K GNE-positive subset (21 participants) and full eligible population (26 participants)
From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration or death due to any cause.
Outcome measures
| Measure |
Arm I (GDC-0032)
n=26 Participants
Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
Investigator-assessed Progression Free Survival (IA-PFS) in Both the Subset of Participants Defined to be PI3K GNE-positive and in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
PI3K GNE-positive subset
|
2.9 months
Interval 1.8 to 4.0
|
|
Investigator-assessed Progression Free Survival (IA-PFS) in Both the Subset of Participants Defined to be PI3K GNE-positive and in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
Full eligible population
|
2.7 months
Interval 1.8 to 4.0
|
SECONDARY outcome
Timeframe: From time of registration to maximum of 3 years.Population: PI3K GNE-positive subset (21 participants) and full eligible population (26 participants)
From date of sub-study registration to date of death due to any cause assessed by local review.
Outcome measures
| Measure |
Arm I (GDC-0032)
n=26 Participants
Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
Investigator-assessed Overall Survival (OS) in Both the Subset of Participants Defined to be PI3K GNE-positive and in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
PI3K GNE-positive subset
|
5.9 months
Interval 4.2 to 7.8
|
|
Investigator-assessed Overall Survival (OS) in Both the Subset of Participants Defined to be PI3K GNE-positive and in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
Full eligible population
|
5.9 months
Interval 4.2 to 9.6
|
SECONDARY outcome
Timeframe: From time of registration to maximum of 3 years.Population: Eligible participants that received protocol treatment.
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Outcome measures
| Measure |
Arm I (GDC-0032)
n=26 Participants
Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
ORR in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
Confirmed Partial Response
|
1 Participants
|
|
ORR in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
Stable/No Response
|
16 Participants
|
|
ORR in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
Progression
|
7 Participants
|
|
ORR in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
Early Death
|
1 Participants
|
|
ORR in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.
Assessment Inadequate
|
1 Participants
|
SECONDARY outcome
Timeframe: From time of registration to maximum of 3 years.Population: This study only had one responder.
Among participants who had a response, duration is calculated from registration to response date.
Outcome measures
| Measure |
Arm I (GDC-0032)
n=1 Participants
Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
Duration of Response (DoR) Both in the Entire S1400B PI3K FMI Positive Study Population and in GNE Positive Participants Treated With GDC-0032 Who Achieve a CR or PR (Confirmed and Unconfirmed) by RECIST 1.1.
|
4.4 months
|
SECONDARY outcome
Timeframe: From date of registration to maximum of 3 years.Population: Eligible participants that received protocol treatment and had greater than grade 2 toxicity.
Frequency and severity of toxicities greater than Grade 2 associated with GDC-0032.
Outcome measures
| Measure |
Arm I (GDC-0032)
n=26 Participants
Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Taselisib: Given PO
|
|---|---|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Cardiac arrest
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Dehydration
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Diarrhea
|
5 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Dyspnea
|
3 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Fatigue
|
3 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Hyperglycemia
|
5 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Hypertension
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Hyponatremia
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Hypoxia
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Lung infection
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Lymphocyte count decreased
|
3 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Nausea
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Platelet count decreased
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Pneumonitis
|
2 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Pneumothorax
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Rash maculo-papular
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Respiratory failure
|
1 participants
|
|
Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)
Vomiting
|
1 participants
|
Adverse Events
GDC-0032
Serious events: 15 serious events
Other events: 25 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
GDC-0032
n=26 participants at risk
GDC-0032
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Cardiac disorders
Atrial flutter
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Cardiac disorders
Cardiac arrest
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Cardiac disorders
Sinus bradycardia
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
4/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Fatigue
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Fever
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Non-cardiac chest pain
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Pain
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Infections and infestations
Kidney infection
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Infections and infestations
Lung infection
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Infections and infestations
Sepsis
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Infections and infestations
Wound infection
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Blood bilirubin increased
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Lymphocyte count decreased
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Nervous system disorders
Nervous system disorders-Other
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Psychiatric disorders
Agitation
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Psychiatric disorders
Hallucinations
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Psychiatric disorders
Psychosis
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Renal and urinary disorders
Hematuria
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.2%
5/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
|
Vascular disorders
Superior vena cava syndrome
|
3.8%
1/26 • From date of registration to maximum of 3 years.
|
Other adverse events
| Measure |
GDC-0032
n=26 participants at risk
GDC-0032
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
34.6%
9/26 • From date of registration to maximum of 3 years.
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
61.5%
16/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
4/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Chills
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Edema limbs
|
26.9%
7/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Fatigue
|
61.5%
16/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Fever
|
15.4%
4/26 • From date of registration to maximum of 3 years.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Infections and infestations
Lung infection
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Alkaline phosphatase increased
|
23.1%
6/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Creatinine increased
|
30.8%
8/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Investigations-Other
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Lipase increased
|
15.4%
4/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Lymphocyte count decreased
|
34.6%
9/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Platelet count decreased
|
15.4%
4/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Serum amylase increased
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Investigations
Weight loss
|
42.3%
11/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
57.7%
15/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
73.1%
19/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.8%
8/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
26.9%
7/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.9%
7/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
42.3%
11/26 • From date of registration to maximum of 3 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
15.4%
4/26 • From date of registration to maximum of 3 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • From date of registration to maximum of 3 years.
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Psychiatric disorders
Depression
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.5%
10/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.5%
10/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.4%
4/26 • From date of registration to maximum of 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
2/26 • From date of registration to maximum of 3 years.
|
|
Vascular disorders
Hypertension
|
15.4%
4/26 • From date of registration to maximum of 3 years.
|
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