Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

NCT03672773 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 18-001387NCI-2018-01409TRIO-US L-07
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

Brief Summary

This phase II trial studies how effective talazoparib and temozolomide are for treating participants with extensive-stage small cell lung cancer that has come back after an initial chemotherapy treatment. Talazoparib, a PARP inhibitor, may stop the growth of tumor cells by preventing them from repairing their DNA. Chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib and temozolomide may work better in treating participants with extensive-stage small cell lung cancer than either one alone.

Conditions

Recurrent Extensive Stage Small Cell Lung Carcinoma; Refractory Extensive Stage Small Cell Lung Carcinoma

Keywords

Small Cell Lung Cancer; PARP Inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective response rate defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIS)T 1.1

  Will be provided along with the corresponding exact 2-sided 95% confidence interval calculated using a method based on the F distribution.

  Up to 1 year

Secondary Outcomes (6)

• Progression-Free Survival (PFS) assessed by RECIST 1.1

  From treatment initiation to time of first documentation of objective tumor progression or death on study due to any cause, whichever occurs first, assessed up to 1 year

• PFS assessed by RECIST 1.1

  From treatment initiation to time of first documentation of objective tumor progression or death on study due to any cause, whichever occurs first, assessed up to 1 year

• Overall survival

  From treatment initiation to death by any cause, assessed up to 1 year

• Duration of response (CR or PR) per RECIST 1.1

  From the first documentation of objective tumor response, assessed up to 1 year

• Time to response (CR or PR) per RECIST 1.1

  From treatment initiation to the first documentation of objective tumor response, assessed up to 1 year

Study Arms (1)

Treatment (temozolomide, talazoparib)

EXPERIMENTAL

Participants receive temozolomide PO on days 1-5 and talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Talazoparib; Drug: Temozolomide

Interventions

Talazoparib DRUG

Given PO

Also known as: BMN 673, BMN-673

Treatment (temozolomide, talazoparib)

Temozolomide DRUG

Given PO

Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac

Treatment (temozolomide, talazoparib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent.
• Cytologically or histologically confirmed small cell lung cancer (SCLC) with extensive-stage disease.
• Relapsed (progressed within 6 months) or refractory (progressed during or within 4 weeks of completing 1st line platinum based regimen).
• Measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Archival or fresh tissue biopsy available for exploratory analyses.
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1.
• Able to swallow the study drugs, has no known intolerance to study drugs or excipients, and able to comply with study requirements.
• Female participants of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method (defined in protocol) from the time of the first study drug treatment through 45 days after the last study drug treatment.
• Male participants must use a condom when having sex from the time of the first study drug treatment through 105 days after the last study drug treatment. Contraception should be considered for a non-pregnant female partner of childbearing potential.
• Male and female participants must agree not to donate sperm or eggs, respectively, from the first study drug treatment through 105 days and 45 days after the last study drug treatment, respectively.
• Female participants may not be breastfeeding at baseline through 45 days after the last study drug treatment.
• Absolute neutrophil count (ANC) \>= 1,500/mcL
• Platelets \>= 100,000/mcL
• Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
• Glomerular filtration rate (by Cockroft-Gault or equivalent estimation) \>= 30 mL/min

You may not qualify if:

• Has not recovered (recovery is defined as Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =\< 1 or return to baseline) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
• Best response of progressive disease per RECIST 1.1 to first-line platinum doublet chemotherapy.
• Has received more than 1 line of cytotoxic therapy
• Prior immunotherapy and targeted therapies (including rovalpituzumab tesirine) are allowed.
• Prior treatment with a PARP inhibitor (not including iniparib) or temozolomide.
• Use of antineoplastic therapies within 14 days before study treatment initiation.
• Use of any other investigational agent within 14 days before study treatment initiation.
• Received radiation therapy within 14 day before study treatment initiation (single fraction palliative radiotherapy is allowed without a washout).
• Prior thoracic irradiation and prophylactic cranial irradiation are allowed.
• Major surgery within 14 days before study treatment initiation.
• Diagnosis of myelodysplastic syndrome (MDS).
• Gastrointestinal disorder affecting absorption.
• Current or anticipated use of a prohibited P-gp inhibitor or P-gp inducer or BCRP inhibitors.
• History of another cancer within 2 years before study treatment initiation, with the exception of fully treated cancers unlikely to affect the assessment of the study treatment safety or efficacy including early stage breast, prostate, nonmelanomatous skin, thyroid, cervix and endometrial cancer.
• Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Translational Research in Oncology: collaborator
• Pfizer: collaborator

Study Sites (6)

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

St. Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Orlando Health, Inc. d/b/a Orlando Health UF Health Center

Orlando, Florida, 32806, United States

Location

Ft. Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46804, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

talazoparib; Temozolomide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jonathan Goldman, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: September 14, 2018
• Study Start: October 31, 2018
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-07

Locations

US (6)