Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-22 @ 2:37 AM
Study NCT ID:
NCT03830918
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2019-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
An Open-Label Phase 1b Dose-Finding Trial Evaluating the Safety of Niraparib and Temozolomide and Atezolizumab in Participants With Advanced Solid Tumors and Expansion to a Phase 2 Trial Comparing the Effects of Niraparib and Temozolomide Plus Atezolizumab vs. Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy (TRIO-US L-06)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase Ib/II trial studies the best dose of temozolomide and how well it works with niraparib and atezolizumab in treating patients with solid tumors that have spread to other places in the body (advanced) and extensive-stage small cell lung cancer with a complete or partial response to platinum-based first-line chemotherapy. Drugs used in 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. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving temozolomide, niraparib and atezolizumab may work better in treating patients with advanced solid tumors and extensive-stage small cell lung cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the recommended phase II dose (RP2D) of temozolomide in combination with niraparib and atezolizumab. (Phase Ib) II. Evaluate the efficacy of niraparib plus temozolomide plus atezolizumab at RP2D (Arm A) compared with atezolizumab (Arm B) as measured by progression-free survival (PFS). (Phase II)
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone, as measured by overall survival (OS).
II. To evaluate the efficacy of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone, as measured by objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
III. To evaluate the safety of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone as measured by adverse events (AEs).
EXPLORATORY OBJECTIVE:
I. To assess participant-reported outcomes on health-related quality of life and adverse events.
OUTLINE: This is a dose-escalation study of temozolomide. Patients are randomized to 1 of 2 arms.
ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5 and niraparib PO QD on days 1-28. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care atezolizumab intravenously (IV) every 3 weeks in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 8 weeks for 24 weeks, and then every 12 weeks for up to 1 year.
I. Determine the recommended phase II dose (RP2D) of temozolomide in combination with niraparib and atezolizumab. (Phase Ib) II. Evaluate the efficacy of niraparib plus temozolomide plus atezolizumab at RP2D (Arm A) compared with atezolizumab (Arm B) as measured by progression-free survival (PFS). (Phase II)
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone, as measured by overall survival (OS).
II. To evaluate the efficacy of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone, as measured by objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
III. To evaluate the safety of niraparib plus temozolomide plus atezolizumab compared with atezolizumab alone as measured by adverse events (AEs).
EXPLORATORY OBJECTIVE:
I. To assess participant-reported outcomes on health-related quality of life and adverse events.
OUTLINE: This is a dose-escalation study of temozolomide. Patients are randomized to 1 of 2 arms.
ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5 and niraparib PO QD on days 1-28. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care atezolizumab intravenously (IV) every 3 weeks in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 8 weeks for 24 weeks, and then every 12 weeks for up to 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-02806 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |