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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

Must not have

Patients must not have experienced any immune related adverse event, including pneumonitis that led to permanent discontinuation of prior immunotherapy and/or required prolonged high dose of steroids

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of talazoparib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of registration to a maximum of 3 years or death

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, Talazoparib and Avelumab, in patients with advanced lung cancer that has a specific gene mutation (STK11). Talazoparib blocks enzymes needed for cancer cell growth, while Avelumab helps the immune system attack the cancer. This combination aims to be more effective for these patients than existing treatments.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had a bad reaction to immunotherapy that required stopping it or taking high doses of steroids.

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My stomach and intestines work well and I don’t have diseases that affect how my body absorbs medicine.

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I haven't taken steroids or immunosuppressants for autoimmune disease in the last week.

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I do not have any infections that need treatment with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration to a maximum of 3 years or death

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate at 12 Weeks (DCR12)

Objective Response Rate (ORR)

Secondary study objectives

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

100%

Fatigue

100%

Headache

67%

Platelet count decreased

67%

Hyperglycemia

67%

Anemia

67%

Back pain

33%

Alopecia

33%

Weight loss

33%

Sinus tachycardia

33%

Urinary incontinence

33%

Nausea

33%

Gastroesophageal reflux disease

33%

Peripheral motor neuropathy

33%

Investigations - Other, ALT DECREASED

33%

Hyponatremia

33%

Hypoglycemia

33%

Hypothyroidism

33%

Neutrophil count decreased

33%

Creatinine increased

33%

White blood cell decreased

33%

Scoliosis

33%

Hypokalemia

33%

Hypertension

33%

Insomnia

33%

Alanine aminotransferase increased

33%

Peripheral sensory neuropathy

33%

Fever

33%

Diarrhea

33%

Hypermagnesemia

33%

Lymphocyte count decreased

33%

Hypophosphatemia

33%

Skin ulceration

33%

Nervous system disorders - Other, PARALYSIS

33%

Muscle weakness lower limb

33%

Cough

33%

Non-cardiac chest pain

33%

Skin infection

33%

Investigations - Other, BUN DECREASED

33%

Nystagmus

33%

Arthralgia

33%

Gait disturbance

33%

Edema limbs

33%

Chills

33%

Investigations - Other, AST DECREASED

33%

Nervous system disorders - Other, HYPOTONIC

33%

Aspartate aminotransferase increased

33%

Blurred vision

33%

Constipation

33%

Pain in extremity

33%

Alkaline phosphatase increased

33%

Neuralgia

33%

Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA

33%

Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/doseBMN 673 BID+55mg/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 BID+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2820

Talazoparib Tosylate

2020

Completed Phase 2

~70