Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Carcinoma

Recurrence

Small Cell Lung Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

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.

TRIO-US IST Team

David Kanamori, MD

William E. Lawler, MD

Jonathan W. Goldman

Tirrell Tremayne Johnson, MD

Sunil Babu, MD

Shaker Dakhil, MD

Jonathan Goldman, MD

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.

PRIMARY OBJECTIVES:

I. Evaluate the efficacy of talazoparib in combination with temozolomide as measured by objective response rate (ORR).

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of talazoparib plus temozolomide as measured by progression-free survival (PFS), overall survival, duration of response, and time to response.

II. To evaluate the safety, tolerability of talazoparib plus temozolomide. III. To evaluate the pharmacokinetics of talazoparib when given in combination with temozolomide.

IV. To evaluate patient reported outcomes per the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

EXPLORATORY OBJECTIVES:

I. To identify potential biomarkers associated with response to study drug treatment.

OUTLINE:

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

After completion of study treatment, participants are followed up at 30 days and then up to 1 year.

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

A Phase 2 Study of Continuous Talazoparib Plus Intermittent Low-Dose Temozolomide in Patients With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer (TRIO-US L-07)

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

Will be summarized for the safety analysis (SA) set. Will be summarized using the Kaplan-Meier method and displayed graphically when appropriate.

Will be summarized for the SA set. Will be summarized using the Kaplan-Meier method and displayed graphically when appropriate. Median event times and 2-sided 95% confidence interval for each median will be provided.

Will be summarized using the Kaplan-Meier method and displayed graphically when appropriate.

To evaluate the pharmacokinetics (steady state trough plasma concentrations) of talazoparib when given in combination with temozolomide

Translational Research in Oncology

Pfizer

Jonsson Comprehensive Cancer Center

Escalating doses of HTMC0435 and Temozolomide

Recommended phase 2 dose (RP2D) of HTMC0435 and Temozolomide

HTMC0435

Jun Li

Yun Fan, MD

The Phase 1b part of this clinical trial is to investigate the safety and pharmacokinetic (PK) characteristics of HTMC0435 tablets combined with temozolomide in patients with various advanced solid tumors (recurrent small cell lung cancer is preferred). The Phase 2 part of the study is a multi-center, open-label, single-arm trial to investigate the preliminary efficacy of HTMC0435 and temozolomide in patients with recurrent small cell lung cancer (SCLC) at the recommended phase 2 dose.

HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

A Phase 1b/2, Dose-finding and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HTMC0435 With Temozolomide in Patients With Small Cell Lung Cancer

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer	NCT03672773	Recurrent Exten... Refractory Exte...	Talazoparib Temozolomide	18 Years -	Jonsson Comprehensive Cancer Center
HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer	NCT05728619	Recurrent Exten...	HTMC0435 Temozolomide	18 Years - 75 Years	Shanghai Huilun Pharmaceutical Co., Ltd.
HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer	NCT05728619	Recurrent Exten...	HTMC0435 Temozolomide	18 Years - 75 Years	Shanghai Huilun Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for recurrent extensive stage small cell lung carcinoma