Talazoparib for Non-Small Cell Lung Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small Cell Lung Carcinoma+4 MoreTalazoparib - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two drugs to treat patients with STK11-mutated non-squamous non-small cell lung cancer that has recurred or is stage IV.

Eligible Conditions
  • Stage IVA Lung Cancer
  • Stage IVB Lung Cancer
  • Non-Squamous Non-Small Cell Lung Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Stage IV Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: Up to 3 years

12 weeks after registration
Disease Control Rate at 12 Weeks (DCR12)
Week 12
Disease control rate
Year 3
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Year 3
Duration of response
Year 3
Duration of Response (DOR)
Investigator-Assessed Progression-Free Survival (IA-PFS)
Overall Survival (OS)
Year 1
Objective Response Rate (ORR)
Year 3
Progression free survival
Up to 3 years
Best objective response rate (ORR)
Frequency and severity of toxicities
Overall survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
89%Anemia
78%Alkaline phosphatase increased
78%Nausea
78%White blood cell decreased
67%Fatigue
67%Lymphocyte count decreased
56%Headache
56%Hypermagnesemia
56%Pain in extremity
56%Platelet count decreased
56%Neutrophil count decreased
56%Aspartate aminotransferase increased
44%Constipation
44%Hyponatremia
44%Hypoalbuminemia
44%Non-cardiac chest pain
33%Alanine aminotransferase increased
33%Blood bilirubin increased
33%Fever
33%Alopecia
33%Back pain
33%Anorexia
33%Dizziness
33%Diarrhea
33%Proteinuria
33%Hyperglycemia
33%Hypocalcemia
33%Pain
33%Sinus tachycardia
33%Vomiting
33%Creatinine increased
22%Hypercalcemia
22%Hypoxia
22%Nasal congestion
22%Dyspnea
22%Hypernatremia
22%Neck pain
22%Abdominal pain
22%Cough
22%Hypokalemia
22%Hypophosphatemia
22%Hypotension
11%Gastroesophageal reflux disease
11%Hematuria
11%Avascular necrosis
11%Hypomagnesemia
11%Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%Tumor pain
11%Activated partial thromboplastin time prolonged
11%Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%Depression
11%Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%Hemoglobin increased
11%Hypertension
11%Investigations - Other, BICARBONATE DECREASED
11%Mucosal infection
11%Rash acneiform
11%Skin ulceration
11%Tinnitus
11%Gait disturbance
11%Edema face
11%Lymphocyte count increased
11%Irregular menstruation
11%Investigations - Other, BICARBONATE LOW
11%Allergic reaction
11%Bone pain
11%Cystitis noninfective
11%Edema limbs
11%Epistaxis
11%Infections and infestations - Other, SHINGLES ZOSTER
11%Insomnia
11%Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%Muscle weakness right-sided
11%Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%Febrile neutropenia
11%Pericardial effusion
11%Pleural effusion
11%Renal and urinary disorders - Other, BLADDER PAIN
11%Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%Skin hyperpigmentation
11%Stomach pain
11%Thromboembolic event
11%Dysgeusia
11%Urinary retention
11%Urinary urgency
11%Weight loss
11%Periorbital infection
11%Anxiety
11%Investigations - Other, BICARBONATE INCREASED
11%Obesity
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT02116777) in the 600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day ARM group. Side effects include: Anemia with 89%, Alkaline phosphatase increased with 78%, Nausea with 78%, White blood cell decreased with 78%, Fatigue with 67%.

Trial Design

1 Treatment Group

Treatment (talazoparib, avelumab)
1 of 1

Experimental Treatment

47 Total Participants · 1 Treatment Group

Primary Treatment: Talazoparib · No Placebo Group · Phase 2

Treatment (talazoparib, avelumab)Experimental Group · 3 Interventions: Talazoparib, Talazoparib Tosylate, Avelumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
Avelumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,102 Previous Clinical Trials
41,145,939 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
387 Previous Clinical Trials
262,906 Total Patients Enrolled
Ferdinandos SkoulidisPrincipal InvestigatorSouthwest Oncology Group
1 Previous Clinical Trials
27 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

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