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Combination Treatment (Talazoparib Plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation (A LUNG-MAP Treatment Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173507
Recruitment Status : Active, not recruiting
First Posted : November 22, 2019
Results First Posted : January 9, 2023
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Lung Non-Squamous Non-Small Cell Carcinoma
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Interventions Drug: Avelumab
Drug: Talazoparib
Drug: Talazoparib Tosylate
Enrollment 47
Recruitment Details  
Pre-assignment Details 47 participants were initially registered. Five participants were ineligible. In all, 42 participants were eligible and received protocol therapy.
Arm/Group Title Talazoparib Plus Avelumab
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Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

Period Title: Overall Study
Started 42
Completed 0
Not Completed 42
Reason Not Completed
On Treatment             3
Adverse Event             3
Progression/Relapse             34
Death             2
Arm/Group Title Talazoparib Plus Avelumab
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Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
Eligible participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants
63.8
(36.8 to 83.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
21
  50.0%
Male
21
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Hispanic or Latino
1
   2.4%
Not Hispanic or Latino
41
  97.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
American Indian or Alaska Native
1
   2.4%
Asian
1
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  26.2%
White
29
  69.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Prior Lines of Treatment for Stage IV Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
0
4
   9.5%
1
16
  38.1%
2 or more
22
  52.4%
Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
0
10
  23.8%
1
32
  76.2%
[1]
Measure Description:

Participants were graded according to the Zubrod Performance Status Scale. 0 - Fully active, able to carry out on all pre-disease performance without restriction.

1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work.

Weight Loss in the Past 6 Months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
< 5%
25
  59.5%
5 - < 10%
12
  28.6%
10 - < 20%
3
   7.1%
Unknown
2
   4.8%
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Current Smoker
17
  40.5%
Former Smoker
23
  54.8%
Never Smoker
2
   4.8%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Adenocarcinoma
36
  85.7%
Other non-small cell, NOS
6
  14.3%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description

Percentage of participants with confirmed or unconfirmed, complete or partial response to treatment with talazoparib plus avelumab per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

Complete Response (CR): Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm. All disease must be assessed using the same technique as baseline.

Partial Response (PR): Applies only to participants with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.

Time Frame From date of registration to progression or treatment discontinuation, up to 1 year and 9 months
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Eligible and evaluable participants
Arm/Group Title Talazoparib Plus Avelumab
Hide Arm/Group Description:

Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2
(0 to 7)
2.Primary Outcome
Title Disease Control Rate at 12 Weeks (DCR12)
Hide Description Percentage of participants with a best response of Complete Response (CR), Partial Response (PR), Unconfirmed Partial Response (UPR), or Unconfirmed Complete Response (UCR) by/at the second disease assessment at 12 weeks after registration (+/- 2 weeks), or stable disease at 12 weeks after registration (+/- 2 weeks). Participants with missing or delayed disease assessment at 12 weeks (+/- 2 weeks), at or before the disease assessment at 20 weeks (+/- 2 weeks) with documented lack of progression (CR, PR, UPR, UCR, or stable) were coded as having disease control at 12 weeks. Participants not known to have disease control at 12 weeks who have at least 12 weeks of follow-up were coded as not having disease control at 12 weeks.
Time Frame 12 weeks after registration
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Hide Analysis Population Description
Eligible and evaluable participants
Arm/Group Title Talazoparib Plus Avelumab
Hide Arm/Group Description:

Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40
(26 to 55)
3.Secondary Outcome
Title Investigator-Assessed Progression-Free Survival (IA-PFS)
Hide Description

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. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) is used as the date of progression.

Progression is defined as: 20% increase in the sum of appropriate diameters of target lesions and absolute increase of at least 0.5 cm, or unequivocal progression of non-measurable disease, or appearance of any new lesion/site, or death from disease without prior documentation of progression or symptomatic deterioration.

Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Time Frame From date of registration to a maximum of 3 years or death
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Hide Analysis Population Description
Eligible and evaluable participants
Arm/Group Title Talazoparib Plus Avelumab
Hide Arm/Group Description:

Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.6 to 3.9)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description From date of sub-study registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Time Frame From date of registration to a maximum of 3 years or death
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Hide Analysis Population Description
Eligible and evaluable participants
Arm/Group Title Talazoparib Plus Avelumab
Hide Arm/Group Description:

Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
7.6
(6.3 to 12.2)
5.Secondary Outcome
Title Duration of Response (DOR)
Hide Description

From date of first response to first progression assessed by local review or symptomatic deterioration, or death among patients with a response (CR or PR). Those last known to be alive without progression are censored at date of last disease assessment. For those with a missing scan whose next scan shows progression, expected date of the first missing scan is used as progression date.

Complete Response (CR): Disappearance of all target and non-target lesions. No new lesions or disease related symptoms. Lymph nodes must have reduction in short axis to < 1.0cm. Assessed using same technique as baseline.

Partial Response (PR): At least 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Assessed using same technique as baseline.

Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment w/o objective evidence of progression.

Time Frame From date of registration to a maximum of 3 years or death
Hide Outcome Measure Data
Hide Analysis Population Description
Participant with a complete or partial response. As only one participant achieved a response, outcome data is entered as a single number rather than a median.
Arm/Group Title Talazoparib Plus Avelumab
Hide Arm/Group Description:

Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: months
7.3
6.Secondary Outcome
Title Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for routine toxicity reporting and serious adverse events (SAEs).
Time Frame Duration of treatment and follow up until death or 3 years post registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who received at least one dose of protocol treatment
Arm/Group Title Talazoparib Plus Avelumab
Hide Arm/Group Description:

Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: Participants
Anemia 12
Anorexia 1
Atrial flutter 1
Fatigue 1
Febrile neutropenia 1
Generalized muscle weakness 1
Hypokalemia 1
Hyponatremia 1
Hypoxia 1
Lung infection 2
Lymphocyte count decreased 5
Metabolism and nutrition disorders - Other, specify 1
Neutrophil count decreased 1
Non-cardiac chest pain 1
Pain 1
Pain in extremity 1
Platelet count decreased 7
White blood cell decreased 2
Time Frame Duration of treatment and follow-up until death or 3 years post registration
Adverse Event Reporting Description CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
 
Arm/Group Title Talazoparib Plus Avelumab
Hide Arm/Group Description

Participants receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Talazoparib: Given PO Avelumab: Given IV

All-Cause Mortality
Talazoparib Plus Avelumab
Affected / at Risk (%)
Total   30/42 (71.43%) 
Hide Serious Adverse Events
Talazoparib Plus Avelumab
Affected / at Risk (%)
Total   15/42 (35.71%) 
Blood and lymphatic system disorders   
Anemia   8/42 (19.05%) 
Febrile neutropenia   1/42 (2.38%) 
Cardiac disorders   
Atrial flutter   1/42 (2.38%) 
Sinus tachycardia   1/42 (2.38%) 
Gastrointestinal disorders   
Abdominal pain   1/42 (2.38%) 
Nausea   1/42 (2.38%) 
Vomiting   1/42 (2.38%) 
General disorders   
Death NOS   1/42 (2.38%) 
Disease progression   2/42 (4.76%) 
Non-cardiac chest pain   1/42 (2.38%) 
Infections and infestations   
Lung infection   1/42 (2.38%) 
Injury, poisoning and procedural complications   
Fall   1/42 (2.38%) 
Investigations   
Creatinine increased   1/42 (2.38%) 
Lymphocyte count decreased   1/42 (2.38%) 
Platelet count decreased   4/42 (9.52%) 
White blood cell decreased   1/42 (2.38%) 
Metabolism and nutrition disorders   
Hypokalemia   1/42 (2.38%) 
Metabolism and nutrition disorders-Other   1/42 (2.38%) 
Nervous system disorders   
Headache   1/42 (2.38%) 
Nervous system disorders-Other   1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/42 (2.38%) 
Pneumothorax   1/42 (2.38%) 
Respiratory failure   2/42 (4.76%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular   1/42 (2.38%) 
Vascular disorders   
Superior vena cava syndrome   1/42 (2.38%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Talazoparib Plus Avelumab
Affected / at Risk (%)
Total   41/42 (97.62%) 
Blood and lymphatic system disorders   
Anemia   25/42 (59.52%) 
Gastrointestinal disorders   
Abdominal pain   3/42 (7.14%) 
Constipation   6/42 (14.29%) 
Diarrhea   13/42 (30.95%) 
Dry mouth   4/42 (9.52%) 
Dyspepsia   3/42 (7.14%) 
Dysphagia   3/42 (7.14%) 
Nausea   15/42 (35.71%) 
Toothache   3/42 (7.14%) 
Vomiting   8/42 (19.05%) 
General disorders   
Chills   4/42 (9.52%) 
Fatigue   23/42 (54.76%) 
Fever   3/42 (7.14%) 
Non-cardiac chest pain   3/42 (7.14%) 
Pain   9/42 (21.43%) 
Injury, poisoning and procedural complications   
Infusion related reaction   5/42 (11.90%) 
Investigations   
Alanine aminotransferase increased   3/42 (7.14%) 
Alkaline phosphatase increased   9/42 (21.43%) 
Aspartate aminotransferase increased   4/42 (9.52%) 
Creatinine increased   4/42 (9.52%) 
Lymphocyte count decreased   12/42 (28.57%) 
Neutrophil count decreased   10/42 (23.81%) 
Platelet count decreased   17/42 (40.48%) 
Weight loss   13/42 (30.95%) 
White blood cell decreased   13/42 (30.95%) 
Metabolism and nutrition disorders   
Anorexia   12/42 (28.57%) 
Dehydration   5/42 (11.90%) 
Hyperglycemia   5/42 (11.90%) 
Hypoalbuminemia   8/42 (19.05%) 
Hypokalemia   7/42 (16.67%) 
Hyponatremia   7/42 (16.67%) 
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness   3/42 (7.14%) 
Myalgia   3/42 (7.14%) 
Pain in extremity   5/42 (11.90%) 
Nervous system disorders   
Dizziness   6/42 (14.29%) 
Dysgeusia   4/42 (9.52%) 
Headache   6/42 (14.29%) 
Paresthesia   3/42 (7.14%) 
Peripheral sensory neuropathy   6/42 (14.29%) 
Psychiatric disorders   
Insomnia   4/42 (9.52%) 
Respiratory, thoracic and mediastinal disorders   
Cough   9/42 (21.43%) 
Dyspnea   9/42 (21.43%) 
Epistaxis   3/42 (7.14%) 
Pneumonitis   3/42 (7.14%) 
Skin and subcutaneous tissue disorders   
Alopecia   3/42 (7.14%) 
Dry skin   3/42 (7.14%) 
Pruritus   6/42 (14.29%) 
Rash maculo-papular   4/42 (9.52%) 
Vascular disorders   
Hypertension   5/42 (11.90%) 
Hypotension   6/42 (14.29%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lung Committee Statistician
Organization: SWOG Statistics and Data Management Center
Phone: 2066674623
EMail: kmini@fredhutch.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT04173507    
Other Study ID Numbers: S1900C
NCI-2019-07142 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1900C ( Other Identifier: SWOG )
S1900C ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Submitted: November 20, 2019
First Posted: November 22, 2019
Results First Submitted: October 18, 2022
Results First Posted: January 9, 2023
Last Update Posted: January 9, 2023