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Advanced Malignant Solid NeoplasmPhase 1/2NCT03830918

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

A Phase 1/2 study testing Atezolizumab, Niraparib and Quality-of-Life Assessment in people with Advanced Malignant Solid Neoplasm and Extensive Stage Lung Small Cell Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Niraparib and Quality-of-Life Assessment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
6 Mar 2019to 3 Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide informed consent.
  • Cytologically or histologically confirmed advanced and incurable solid malignancy.
  • For the Phase 1b, Part 2 cohort, participants must have a tumor type for which atezolizumab is an Food and Drug Administration (FDA) approved therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.
  • Able to swallow the study drugs, has no known intolerance of study drugs or excipients, and able to comply with study requirements.
  • Absolute neutrophil count (ANC) >= 1,500 /mcL.
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  • Platelets >= 100,000 / mcL.
  • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 4 weeks of first dose).
  • Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance >= 30 mL/min for participants with creatinine levels > 1.5 X institutional ULN. (Glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]).
  • Creatinine clearance should be calculated using the standard Cockcroft and Gault equation.
  • Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN.
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for participants with liver metastases.
  • Albumin >= 2.2 mg/dL.
  • International Normalized Ratio (INR) or Prothrombin Time (PT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy, and then only as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.
  • Activated Partial Thromboplastin Time (aPTT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy, and then only as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the participant to be eligible, and participants must agree to use a highly-effective birth control method from the time of the first study drug treatment through 180 days after the last study drug treatment, or be of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons):
  • >= 45 years of age and has not had menses for > 1 year
  • Participants who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
  • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
  • Male participants must use a condom when having sex with a pregnant woman and when having sex with a woman of childbearing potential from the time of the first study-drug treatment through 180 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 180 days after the last study drug treatment.
  • Female participants must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
  • Participants must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • FOR PHASE 2 ONLY: Cytologically or histologically confirmed advanced and incurable solid malignancy. For the randomized phase 2 portion of the trial, cytologically or histologically confirmed small cell lung carcinoma (SCLC) with extensive-stage disease is required.
  • FOR PHASE 2 ONLY: Complete response (CR) or partial response (PR) (per RECIST 1.1) following 4 to 6 cycles of platinum-based chemotherapy.
  • Thoracic irradiation received as part of the treatment regimen and prophylactic cranial irradiation with a washout period of 14 days are allowed. Participants with limited stage disease receiving thoracic irradiation are excluded.
  • FOR PHASE 2 ONLY: Able to proceed to randomization within 7 weeks after day 1 of the last cycle of prior chemotherapy.

Who cannot join

  • Has not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 4.0, grade =< 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
  • Use of antineoplastic therapies within 21 days before day 1 of study treatment. (Atezolizumab does not require a washout.) Use of prophylactic cranial irradiation or thoracic irradiation within 14 days before day 1 of study treatment. Palliative radiation to bone lesions must be completed at least 7 days before day 1 of study treatment.
  • Use of any other investigational agent within 21 days before day 1 of study treatment.
  • Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded.
  • Serious accompanying disorder or impaired organ function, including the following:
  • Cardiac (within 3 months before randomization): any unstable ischemic disease, heart failure, or untreated arrhythmia.
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  • Major surgery within 3 weeks before day 1 of study treatment.
  • Requirement for IV alimentation (at the time of day 1 of study treatment).
  • Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • History of another cancer within 3 years before day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded.
  • Gastrointestinal disorder affecting absorption.
  • Participants must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
  • Participants must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
  • Participants must not be pregnant.
  • For both arms in phase 2, participants should already be receiving atezolizumab infusions and will continue to do so while on trial. There should be no contra-indication to a PD-1 or PD-L1 inhibitor in the opinion of the treating investigator. This includes active autoimmune disease or a chronic medical condition that requires chronic steroid therapy or immunosuppressive medication, above a dose equivalent to 10 mg prednisone. Exceptions include participants with vitiligo, resolved childhood asthma/atopy, participants who require intermittent use of bronchodilators or local steroid injections, and participants with a history of hypothyroidism or adrenal insufficiency taking a stable dose of replacement therapy.
  • FOR PHASE 2 ONLY: Prior treatment with a PARP inhibitor (not including iniparib).
  • FOR PHASE 2 ONLY: Participants must not have progressed following first-line chemotherapy. Participants must continue maintenance atezolizumab started during initial treatment for extensive stage (ES)-SCLC.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

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)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Atezolizumab, Niraparib, Quality-of-Life Assessment, Questionnaire Administration, Temozolomide
Keywords
Small Cell Lung Cancer, SCLC, PARP Inhibitor, Maintenance Therapy
Medical subject headings
Lung Neoplasms, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabBiological

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • NiraparibDrug

    Also called MK-4827, MK4827

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • TemozolomideDrug

    Also called 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

    Given PO

Study groups in NCT03830918
Study groupRoleWhat they receive
Arm A (temozolomide, niraparib, atezolizumab)ExperimentalPatients receive temozolomide PO 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 IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Atezolizumab; Drug: Niraparib; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide
Arm B (atezolizumab)Active comparatorPatients receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Atezolizumab; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase II dose of niraparib and temozolomide combination (Phase Ib)

    Measured: At 28 days

  2. Progression-free survival (Phase II)

    Assessed per Response Evaluation Criteria in Solid Tumors 1.1. A Cox proportional hazards model will be used to estimate the hazard ratio and its 95% confidence interval. A one-sided stratified log-rank tests will be used to compare Arm A versus Arm B.

    Measured: From randomization to cancer progression, assessed up to 36 months

Secondary outcomes (3)

  1. Objective response rate

    Defined as a partial or complete tumor response per RECIST 1.1.

    Measured: Up to 36 months

  2. Overall survival

    A one-sided stratified log-rank tests will compare Arm A versus Arm B.

    Measured: From randomization to death by any cause, assessed up to 36 months

  3. Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.0

    Incidence of adverse events (AEs) occurring during the study will be summarized by system organ class and preferred term. Adverse events will also be summarized by causality and grade. Serious adverse events will be listed separately. Descriptive summary statistics will be used to summarize changes over time in laboratory values, vital signs, physical examination findings, and Eastern Cooperative Oncology Group (ECOG) performance status, for all treated participants.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2019
  2. Study start6 Mar 2019
  3. Primary completion3 Jan 2027 (estimated)
  4. Study completion3 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03830918
Sponsor's protocol ID
18-001791
Other IDs
NCI-2018-02806
Status last verified
Nov 2025
First submitted
4 Feb 2019
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Atezolizumab, Niraparib and Quality-of-Life Assessment in people with Advanced Malignant Solid Neoplasm and Extensive Stage Lung Small Cell Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase II dose of niraparib and temozolomide combination (Phase Ib) (time frame: At 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03830918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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