Stage III Lung Cancer AJCC v8 Clinical Trial
Official title:
Niraparib (PARP Inhibitor) Plus Dostarlimab (Anti-PD1) for Small Cell Lung Cancer (SCLC) and Other High-Grade Neuroendocrine Carcinomas (NEC)
Verified date | August 2023 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies the effect of niraparib and dostarlimab in treating small cell lung cancer and other high-grade neuroendocrine carcinomas. 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 dostarlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and dostarlimab may help to control the diseases.
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | May 30, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participant must have unresected or locally advanced small cell lung cancer (Cohort 1) or high-grade neuroendocrine carcinoma (Cohort 2) confirmed by staff pathologist. High-grade neuroendocrine carcinoma of prostate (e.g. aggressive variant prostate cancer, small cell of prostate, etc.) are excluded - Patients must have had at least one prior line of systemic therapy directed at their malignancy - Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 - Participant must be >= 18 years of age - Absolute neutrophil count >= 1,500/uL - Platelets >= 100,000/uL - Hemoglobin >= 9 g/dL - Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance >= 60 mL/min using the Cockcroft-Gault equation - Total bilirubin =< 1.5 x ULN (=< 2.0 in patients with known Gilberts syndrome) OR direct bilirubin =< 1 x ULN - Aspartate aminotransferase and alanine aminotransferase =< 2.5 x ULN unless liver metastases are present, in which case they must be =< 5 x ULN - International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants - Participant receiving corticosteroids may continue as long as their dose equivalent to 10 mg prednisone or less and is stable for least 4 weeks prior to initiating protocol therapy - Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment - Female participant has a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees use an adequate method of contraception from screening through 180 days after the last dose of study treatment, or is 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 - Patients 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, otherwise the patient must be willing to use an adequate barrier method throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient - Pelvic irradiation - Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment - Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient - Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial Exclusion Criteria: - Participant must not be simultaneously enrolled in any interventional clinical trial - Participant must not have previously received a simultaneous combination of PARP inhibitor and immune checkpoint blockade (immunotherapy) - Participant must not have had major surgery =< 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects - Participant must not have received investigational therapy =< 4 weeks prior initiating protocol therapy - Participant has had radiation therapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy - Participant must not have a known hypersensitivity to niraparib and dostarlimab components or excipients - Participant must not have received a transfusion (platelets or red blood cells) =< 4 weeks prior to initiating protocol therapy - Participant 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 - Participant has had any known grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment - Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) - Participant must not have 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 - Participant must not have had diagnosis, detection, or treatment of another type of cancer =< 2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated) - Participant must not have known, symptomatic brain or leptomeningeal metastases. Patients should have magnetic resonance imaging (MRI) brain with and without contrast (or computed tomography [CT] head with and without contrast) within 4 weeks prior to initiation of therapy. If history of known brain metastases, these must be treated with completion of treatment at least two weeks prior to initiation of therapy. Known brain metastases must be clinically stable and asymptomatic - Patient experienced >= grade 3 immune-related adverse event (AE) with prior immunotherapy - Participant has a diagnosis of immunodeficiency or has received systemic steroid therapy in excess of 10 mg prednisone (or equivalent) or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy - Participant has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected) - Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment - Participant must not have a history of interstitial lung disease - Participant has received a live vaccine within 14 days of initiating protocol therapy |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-month Progression free survival (PFS) | Defined as the number (or fraction) of patients who are alive without evidence of progression at 6 months from initiation of therapy. Progression will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria using investigator's review. As there is no comparator arm, the rates will be considered in the context of historical controls. Will be performed using Kaplan-Meier methods for each cohort. Quartiles (i.e. 25th percentile, median, 75th percentile) and associated two-sided 95% confidence intervals will be provided. Estimates of PFS at 6-months will be estimated from Kaplan-Meier survival curve. | Time from the start of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression, assessed at 6 months | |
Primary | Objective response rate (ORR) | Defined as the percentage of patients with complete response (CR) or partial response (PR), as assessed by RECIST v.1.1 criteria using independent central review by MD Anderson Quantitative Imaging Analysis Core. As there is no comparator arm, the rates will be considered in the context of historical controls. | At 3 months | |
Secondary | 12-week disease control rate | Defined as the percentage of patients with CR, PR, or stable disease, as assessed by RECIST v.1.1 criteria using (independent central or investigator's) review at 12 weeks from initiation of therapy. | At 12 weeks | |
Secondary | Progression free survival | Progression will be assessed by RECIST v.1.1 criteria using investigator's review. Will be performed using Kaplan-Meier methods for each cohort. Quartiles (i.e. 25th percentile, median, 75th percentile) and associated two-sided 95% confidence intervals will be provided. Estimates of PFS at 6-months and 12-months will be estimated from Kaplan-Meier survival curve. | Time from the start of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression, assessed up to 12 months | |
Secondary | Overall survival (OS) | Will be performed using Kaplan-Meier methods for each cohort. Quartiles (i.e. 25th percentile, median, 75th percentile) and associated two-sided 95% confidence intervals will be provided. Estimates of OS at 6-months and 12-months will be estimated from Kaplan-Meier survival curve. | From the start of study treatment to the date of death by any cause, assessed up to 5 years | |
Secondary | Incidence of adverse events (AEs) | Defined as frequency and grade of adverse events. All AEs will be assessed by the investigator for severity according to Common Terminology Criteria for Adverse Events v5.0. | Up to 90 days post-treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT04183218 -
Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
|
||
Active, not recruiting |
NCT04013542 -
Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03801902 -
Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), The ARCHON-1 Trial
|
Phase 1 | |
Terminated |
NCT04396535 -
Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04514497 -
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT04073745 -
Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer
|
Phase 1 | |
Withdrawn |
NCT04186988 -
[18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy
|
Early Phase 1 | |
Active, not recruiting |
NCT03637816 -
Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
Recruiting |
NCT06122064 -
A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
|
N/A | |
Active, not recruiting |
NCT03731585 -
Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment
|
N/A | |
Active, not recruiting |
NCT03776253 -
Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer
|
N/A | |
Recruiting |
NCT04314401 -
National Cancer Institute "Cancer Moonshot Biobank"
|
||
Terminated |
NCT04862195 -
Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
|
N/A | |
Active, not recruiting |
NCT03939481 -
Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
|
||
Recruiting |
NCT05624996 -
Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer
|
Phase 3 | |
Active, not recruiting |
NCT04227028 -
Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC
|
Phase 1 | |
Recruiting |
NCT05733000 -
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT04819997 -
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
|
N/A |