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Monoclonal Antibodies

Talazoparib + Avelumab for Lung Cancer

Phase 2
Waitlist Available
Led By Ferdinandos Skoulidis
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be assigned to S1900C based on genomic profiling using the FoundationOne assay
Patients must not be taking, nor plan to take while on protocol treatment strong P-glycoprotein (P-gp) inhibitors, P-gp inducers, or strong breast cancer resistance protein (BCRP) inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration to a maximum of 3 years or death
Awards & highlights

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.

Who is the study for?
This trial is for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has an STK11 gene mutation. Participants must not be pregnant, have had certain treatments recently, or have conditions affecting drug absorption. They should not have a history of severe allergies to monoclonal antibodies and must agree to blood specimen submissions.Check my eligibility
What is being tested?
The study tests the combination of Talazoparib (a drug blocking enzymes needed for tumor growth) and Avelumab (an immunotherapy antibody). It aims to see if this combo is more effective in treating lung cancers with an STK11 gene mutation compared to current therapies.See study design
What are the potential side effects?
Possible side effects include allergic reactions related to Avelumab, issues from immune system activation such as inflammation in various organs, fatigue, nausea, and potential complications due to Talazoparib's effect on cellular enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer treatment is based on specific genetic test results.
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I am not using, nor will I use strong medication inhibitors or inducers while on this treatment.
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My kidney function, measured by creatinine levels, is normal or near normal.
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I am not planning to receive any other cancer treatments while on this study.
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My lung cancer is advanced or has come back and is not mainly squamous cell type.
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I have not had any other cancer types, except for certain allowed cases.
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I have been treated with anti-PD-1 or anti-PD-L1 therapy for advanced or recurrent disease.
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I have never been treated with a PARP inhibitor.
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I do not have severe heart disease.
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My condition worsened after my last treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to a maximum of 3 years or death
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to a maximum of 3 years or death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control Rate at 12 Weeks (DCR12)
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Investigator-Assessed Progression-Free Survival (IA-PFS)
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777
89%
Anemia
78%
Alkaline phosphatase increased
78%
Nausea
78%
White blood cell decreased
67%
Fatigue
67%
Lymphocyte count decreased
56%
Aspartate aminotransferase increased
56%
Hypermagnesemia
56%
Headache
56%
Neutrophil count decreased
56%
Platelet count decreased
56%
Pain in extremity
44%
Hypoalbuminemia
44%
Constipation
44%
Non-cardiac chest pain
44%
Hyponatremia
33%
Creatinine increased
33%
Hypocalcemia
33%
Anorexia
33%
Back pain
33%
Diarrhea
33%
Alanine aminotransferase increased
33%
Alopecia
33%
Blood bilirubin increased
33%
Dizziness
33%
Fever
33%
Hyperglycemia
33%
Pain
33%
Proteinuria
33%
Sinus tachycardia
33%
Vomiting
22%
Hypokalemia
22%
Cough
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Bone pain
11%
Febrile neutropenia
11%
Edema limbs
11%
Allergic reaction
11%
Tumor pain
11%
Weight loss
11%
Periorbital infection
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Irregular menstruation
11%
Dysgeusia
11%
Hemoglobin increased
11%
Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%
Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%
Urinary urgency
11%
Renal and urinary disorders - Other, BLADDER PAIN
11%
Anxiety
11%
Avascular necrosis
11%
Depression
11%
Hypomagnesemia
11%
Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%
Edema face
11%
Hematuria
11%
Lymphocyte count increased
11%
Activated partial thromboplastin time prolonged
11%
Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%
Cystitis noninfective
11%
Epistaxis
11%
Gait disturbance
11%
Gastroesophageal reflux disease
11%
Hypertension
11%
Infections and infestations - Other, SHINGLES ZOSTER
11%
Insomnia
11%
Investigations - Other, BICARBONATE DECREASED
11%
Investigations - Other, BICARBONATE INCREASED
11%
Investigations - Other, BICARBONATE LOW
11%
Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%
Mucosal infection
11%
Muscle weakness right-sided
11%
Pericardial effusion
11%
Pleural effusion
11%
Rash acneiform
11%
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%
Skin hyperpigmentation
11%
Skin ulceration
11%
Stomach pain
11%
Thromboembolic event
11%
Tinnitus
11%
Urinary retention
11%
Obesity
100%
80%
60%
40%
20%
0%
Study treatment Arm
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (talazoparib, avelumab)Experimental Treatment3 Interventions
Patients 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2770
Talazoparib Tosylate
2015
Completed Phase 2
~30
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,573 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,317 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,214 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04173507 — Phase 2
Lung Cancer Research Study Groups: Treatment (talazoparib, avelumab)
Lung Cancer Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04173507 — Phase 2
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04173507 — Phase 2
~9 spots leftby Jun 2025
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