Trial Outcomes & Findings for 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) (NCT NCT04173507)

Last Updated: 2024-09-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

From date of registration to progression or treatment discontinuation, up to 1 year and 9 months

Results posted on

2024-09-03

Participant Flow

47 participants were initially registered. Five participants were ineligible. In all, 42 participants were eligible and received protocol therapy.

Participant milestones

Participant milestones
Measure	Talazoparib Plus Avelumab 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 Study STARTED	42
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Talazoparib Plus Avelumab 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 Study On Treatment	3
Overall Study Adverse Event	3
Overall Study Progression/Relapse	34
Overall Study Death	2

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Talazoparib Plus Avelumab n=42 Participants 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
Age, Continuous	63.8 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 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	11 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Prior Lines of Treatment for Stage IV Disease 0	4 Participants n=5 Participants
Prior Lines of Treatment for Stage IV Disease 1	16 Participants n=5 Participants
Prior Lines of Treatment for Stage IV Disease 2 or more	22 Participants n=5 Participants
Performance Status 0	10 Participants n=5 Participants
Performance Status 1	32 Participants n=5 Participants
Weight Loss in the Past 6 Months < 5%	25 Participants n=5 Participants
Weight Loss in the Past 6 Months 5 - < 10%	12 Participants n=5 Participants
Weight Loss in the Past 6 Months 10 - < 20%	3 Participants n=5 Participants
Weight Loss in the Past 6 Months Unknown	2 Participants n=5 Participants
Smoking Status Current Smoker	17 Participants n=5 Participants
Smoking Status Former Smoker	23 Participants n=5 Participants
Smoking Status Never Smoker	2 Participants n=5 Participants
Histology Adenocarcinoma	36 Participants n=5 Participants
Histology Other non-small cell, NOS	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of registration to progression or treatment discontinuation, up to 1 year and 9 months

Population: Eligible and evaluable participants

Outcome measures

Outcome measures
Measure	Talazoparib Plus Avelumab n=42 Participants 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
Objective Response Rate (ORR)	2 percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: 12 weeks after registration

Population: Eligible and evaluable participants

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.

Outcome measures

Outcome measures
Measure	Talazoparib Plus Avelumab n=42 Participants 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
Disease Control Rate at 12 Weeks (DCR12)	40 percentage of participants Interval 26.0 to 55.0

SECONDARY outcome

Timeframe: From date of registration to a maximum of 3 years or death

Population: Eligible and evaluable 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. 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.

Outcome measures

Outcome measures
Measure	Talazoparib Plus Avelumab n=42 Participants 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
Investigator-Assessed Progression-Free Survival (IA-PFS)	2.7 months Interval 1.6 to 3.9

SECONDARY outcome

Timeframe: From date of registration to a maximum of 3 years or death

Population: Eligible and evaluable participants

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.

Outcome measures

Outcome measures
Measure	Talazoparib Plus Avelumab n=42 Participants 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 Survival (OS)	7.6 months Interval 6.3 to 12.2

SECONDARY outcome

Timeframe: From date of registration to a maximum of 3 years or death

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Talazoparib Plus Avelumab n=1 Participants 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
Duration of Response (DOR)	7.3 months

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or 3 years post registration

Population: Eligible participants who received at least one dose of protocol treatment

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).

Outcome measures

Outcome measures
Measure	Talazoparib Plus Avelumab n=42 Participants 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
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyponatremia	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypokalemia	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anemia	12 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anorexia	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Atrial flutter	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 Generalized muscle weakness	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypoxia	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lung infection	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	5 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Metabolism and nutrition disorders - Other, specify	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 Non-cardiac chest pain	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain in extremity	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Platelet count decreased	7 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	2 Participants

Adverse Events

Talazoparib Plus Avelumab

Serious events: 15 serious events

Other events: 41 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Talazoparib Plus Avelumab n=42 participants at risk 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
Blood and lymphatic system disorders Anemia	19.0% 8/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Cardiac disorders Atrial flutter	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Cardiac disorders Sinus tachycardia	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Abdominal pain	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Nausea	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Vomiting	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
General disorders Death NOS	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
General disorders Disease progression	4.8% 2/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
General disorders Non-cardiac chest pain	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Infections and infestations Lung infection	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Injury, poisoning and procedural complications Fall	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Creatinine increased	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Lymphocyte count decreased	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Platelet count decreased	9.5% 4/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations White blood cell decreased	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Metabolism and nutrition disorders Hypokalemia	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Metabolism and nutrition disorders Metabolism and nutrition disorders-Other	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Nervous system disorders Headache	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Nervous system disorders Nervous system disorders-Other	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.8% 2/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Vascular disorders Superior vena cava syndrome	2.4% 1/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.

Other adverse events

Other adverse events
Measure	Talazoparib Plus Avelumab n=42 participants at risk 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
Blood and lymphatic system disorders Anemia	59.5% 25/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Abdominal pain	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Constipation	14.3% 6/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Diarrhea	31.0% 13/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Dry mouth	9.5% 4/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Dyspepsia	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Dysphagia	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Nausea	35.7% 15/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Toothache	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Gastrointestinal disorders Vomiting	19.0% 8/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
General disorders Chills	9.5% 4/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
General disorders Fatigue	54.8% 23/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
General disorders Fever	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
General disorders Non-cardiac chest pain	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
General disorders Pain	21.4% 9/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Injury, poisoning and procedural complications Infusion related reaction	11.9% 5/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Alanine aminotransferase increased	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Alkaline phosphatase increased	21.4% 9/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Aspartate aminotransferase increased	9.5% 4/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Creatinine increased	9.5% 4/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Lymphocyte count decreased	28.6% 12/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Neutrophil count decreased	23.8% 10/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Platelet count decreased	40.5% 17/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations Weight loss	31.0% 13/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Investigations White blood cell decreased	31.0% 13/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Metabolism and nutrition disorders Anorexia	28.6% 12/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Metabolism and nutrition disorders Dehydration	11.9% 5/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Metabolism and nutrition disorders Hyperglycemia	11.9% 5/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	19.0% 8/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Metabolism and nutrition disorders Hypokalemia	16.7% 7/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Metabolism and nutrition disorders Hyponatremia	16.7% 7/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	11.9% 5/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Nervous system disorders Dizziness	14.3% 6/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Nervous system disorders Dysgeusia	9.5% 4/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Nervous system disorders Headache	14.3% 6/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Nervous system disorders Paresthesia	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Nervous system disorders Peripheral sensory neuropathy	14.3% 6/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Psychiatric disorders Insomnia	9.5% 4/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Cough	21.4% 9/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	21.4% 9/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Skin and subcutaneous tissue disorders Alopecia	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Skin and subcutaneous tissue disorders Dry skin	7.1% 3/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Skin and subcutaneous tissue disorders Pruritus	14.3% 6/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.5% 4/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Vascular disorders Hypertension	11.9% 5/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for adverse events.
Vascular disorders Hypotension	14.3% 6/42 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 42 participants were assessed for 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

Restriction type: LTE60