Testando a adição de uma droga anticancerígena, berzosertib (M6620, VX-970), aos tratamentos usuais (carboplatina e gemcitabina) e ao pembrolizumab para pacientes com câncer avançado de pulmão de células não pequenas células escamosas
Estudo Fase IB e Fase II Randomizado e Aberto de Berzosertib (M6620, VX-970) em Combinação com Carboplatina/Gemcitabina/Pembrolizumab em Pacientes com Câncer de Pulmão de Células Não Pequenas Avançado de Histologia de Células Escamosas Sem Tratamento Avançado
This phase Ib/II trial studies the best dose of carboplatin when given together with berzosertib, gemcitabine and pembrolizumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer that has spared to other placed in the body (advanced). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and gemcitabine, 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving berzosertib together with carboplatin, gemcitabine, and pembrolizumab may work better in treating patients with squamous cell non-small cell lung cancer compared to carboplatin, gemcitabine, and pembrolizumab alone.
Visão geral do estudo
Status
Descrição detalhada
PRIMARY OBJECTIVES:
I. To determine the recommended phase 2 dose (RP2D) of carboplatin in combination with berzosertib (M6620) and gemcitabine/pembrolizumab, in patients with squamous cell non-small cell lung cancer (Sq-NSCLC). (Lead-in Phase 1B) II. To compare progression-free survival (PFS) of carboplatin/gemcitabine/pembrolizumab with and without berzosertib (M6620, VX-970) in patients with Sq-NSCLC, as measured by a hazard ratio in an intent-to-treat analysis. (Phase 2)
SECONDARY OBJECTIVES:
I. To compare progression-free survival (PFS) of carboplatin/gemcitabine/pembrolizumab with and without berzosertib (M6620, VX-970) in patients with Sq-NSCLC, as measured by a hazard ratio in an as-treated analysis.
II. To compare PFS of carboplatin/gemcitabine/pembrolizumab with and without berzosertib (M6620, VX-970) in patients with ataxia telangiectasia mutated (ATM)-deficient Sq-NSCLC, as measured by a hazard ratio.
III. To compare overall survival (OS) and overall response rate (ORR) of carboplatin/gemcitabine/pembrolizumab with and without berzosertib (M6620, VX-970), in patients with chemotherapy-naive Sq-NSCLC.
IV. To determine the systemic drug exposure of berzosertib (M6620, VX-970) and gemcitabine, as correlates of efficacy and toxicity.
V. To determine the safety and tolerability of berzosertib (M6620, VX-970) in combination with carboplatin/gemcitabine/pembrolizumab.
VI. To observe and record anti-tumor activity.
EXPLORATORY OBJECTIVES:
I. To identify molecular subpopulations of patients who have increased sensitivity to the berzosertib (M6620, VX-970)/carboplatin/gemcitabine/pembrolizumab combination.
II. To explore the prognostic and predictive qualities of the ATM immunohistochemistry (IHC) assay for clinical response and PFS.
III. To explore inflammation-associated gene signatures and clinical response.
OUTLINE: This is a phase Ib, dose de-escalation study of carboplatin followed by a phase II study. Patients are randomized to 1 of 2 arms.
ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and berzosertib IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab IV over 30 minutes on day 1 and berzosertib IV over 60 minutes on days 2 and 9. Cycles repeat every 21 days for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab alone IV over 30 minutes on day 1. Cycles repeat every 6 weeks for up to 1 more year in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) scans and/or computed tomography (CT) scans, and undergo blood specimen collection on study.
ARM B: Patients receive pembrolizumab, gemcitabine hydrochloride, and carboplatin as in Arm A. Patients undergo MRI scans and/or CT scans, and undergo blood specimen collection on study.
After completion of study treatment, patients are followed up every 3 months for 12 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
-
-
California
-
Los Angeles, California, Estados Unidos, 90033
- USC / Norris Comprehensive Cancer Center
-
Los Angeles, California, Estados Unidos, 90020
- Keck Medicine of USC Koreatown
-
Los Angeles, California, Estados Unidos, 90033
- Los Angeles General Medical Center
-
Newport Beach, California, Estados Unidos, 92663
- USC Norris Oncology/Hematology-Newport Beach
-
-
Florida
-
Aventura, Florida, Estados Unidos, 33180
- UM Sylvester Comprehensive Cancer Center at Aventura
-
Coral Gables, Florida, Estados Unidos, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
-
Deerfield Beach, Florida, Estados Unidos, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
-
Miami, Florida, Estados Unidos, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
-
Kansas
-
Fairway, Kansas, Estados Unidos, 66205
- University of Kansas Clinical Research Center
-
Hays, Kansas, Estados Unidos, 67601
- HaysMed
-
Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Cancer Center
-
Lawrence, Kansas, Estados Unidos, 66044
- Lawrence Memorial Hospital
-
Olathe, Kansas, Estados Unidos, 66061
- The University of Kansas Cancer Center - Olathe
-
Overland Park, Kansas, Estados Unidos, 66210
- University of Kansas Cancer Center-Overland Park
-
Overland Park, Kansas, Estados Unidos, 66211
- University of Kansas Hospital-Indian Creek Campus
-
Pittsburg, Kansas, Estados Unidos, 66762
- Mercy Hospital Pittsburg
-
Salina, Kansas, Estados Unidos, 67401
- Salina Regional Health Center
-
Topeka, Kansas, Estados Unidos, 66606
- University of Kansas Health System Saint Francis Campus
-
Westwood, Kansas, Estados Unidos, 66205
- University of Kansas Hospital-Westwood Cancer Center
-
-
Missouri
-
City of Saint Peters, Missouri, Estados Unidos, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, Estados Unidos, 63141
- Siteman Cancer Center at West County Hospital
-
Kansas City, Missouri, Estados Unidos, 64154
- University of Kansas Cancer Center - North
-
Kansas City, Missouri, Estados Unidos, 64108
- University Health Truman Medical Center
-
Lee's Summit, Missouri, Estados Unidos, 64064
- University of Kansas Cancer Center - Lee's Summit
-
North Kansas City, Missouri, Estados Unidos, 64116
- University of Kansas Cancer Center at North Kansas City Hospital
-
St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Estados Unidos, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Estados Unidos, 63136
- Siteman Cancer Center at Christian Hospital
-
-
New Hampshire
-
Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New York
-
New York, New York, Estados Unidos, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
-
North Carolina
-
Clemmons, North Carolina, Estados Unidos, 27012
- Wake Forest University at Clemmons
-
Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Health Sciences
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15232
- UPMC Hillman Cancer Center
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients must have histologically confirmed NSCLC of predominantly squamous cell histology, stage IV (American Joint Committee on Cancer [AJCC] 8th edition)
- Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
- Patients must have tumor tissue available at time of enrollment, or be willing to undergo a biopsy for integrated biomarker studies
- Patients with a history of prior platinum-based systemic chemotherapy given as neoadjuvant, adjuvant, or consolidation therapy for early stage or loco-regionally advanced NSCLC are eligible, if therapy is completed one year prior to initiation of treatment. Patients must not have had prior systemic chemotherapy or immunotherapy for metastatic disease
- Patients with prior immunotherapy given as neoadjuvant, adjuvant, or consolidation therapy for early stage or loco-regionally advanced disease are eligible, if treatment is completed one year prior to initiation of treatment
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky > 60%)
- Age >= 18 years. Because no dosing or adverse event data are currently available on the use of these drug combinations in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count > lower limit of normal (LLN)
- Platelets > LLN
- Total bilirubin =< institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
- Creatinine =< institutional ULN OR glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2
- Patients with human immunodeficiency virus (HIV) infection are eligible if they are on effective anti-retroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction
- Patients with evidence of chronic hepatitis B virus (HBV) infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), provided there is no expected drug-drug interaction
- Patients with a history of hepatitis C virus (HCV) infection are eligible if they have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible if clinically stable, i.e., on stable doses of anti-convulsant therapy and/or stable doses of corticosteroids which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- Patients must be willing to comply with birth control requirements: The effects of the agents in this study (or similar agents) on the developing human fetus are either unknown, or known to be teratogenic, embryotoxic, and fetotoxic in mice and rabbits. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completing treatment administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to avoid donating sperm for during the study period, and to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion completing treatment administration
- Patients must have the ability to understand and willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative and/or family member available will also be eligible
Exclusion Criteria:
- Patients with severe intercurrent illness or comorbidity are not eligible
- Patients with contraindications to immunotherapy (e.g., solid organ transplant or active autoimmune disease requiring immunosuppressant therapy within 2 years of enrollment) are not eligible
- Patients with prior systemic chemotherapy for metastatic disease are not eligible
- Patients who are receiving any other investigational agents are not eligible
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to berzosertib (M6620, VX-970), pembrolizumab, gemcitabine, carboplatin, or other agents used in study are not eligible
- Patients with severe bone marrow depression or significant bleeding are not eligible
- Patients with psychiatric illness/social situations that would limit compliance with study requirements are not eligible
- Berzosertib (M6620, VX-970) is primarily metabolized by CYP3A4; therefore, concomitant administration with strong inhibitors of CYP3A4 (e.g. clarithromycin, itraconazole, ketoconazole, HCV and HIV protease inhibitors, nefazodone, posaconazole, telithromycin, voriconazole) or strong inducers of CYP3A4 (e.g. carbamazepine, rifampin, phenobarbital, phenytoin, St. John's wort) should be avoided. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
- Pregnant women are excluded from this study because the agents in this study may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued if the mother is treated with the study agents berzosertib (M6620, VX-970), pembrolizumab, gemcitabine, or carboplatin
- Berzosertib (M6620, VX-970) should be used with caution in patients with clinical evidence of germline defects in their deoxyribonucleic acid (DNA) damage repair pathway (for example, patients with Li-Fraumeni syndrome or ataxia telangiectasia) due to a possible increase in the toxicity of DNA-damaging agents when paired with berzosertib (M6620, VX-970)
- Patients must not have received or be scheduled to receive radiation therapy within 7 days or less from gemcitabine administration
- Current or prior use of immunosuppressive medication within 28 days before the first dose of pembrolizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- Patients must not have received an allogeneic stem cell transplant
- Patients must not have active, uncontrolled infections or recently received active vaccinations
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm A (pembrolizumab, gemcitabine, carboplatin, M6620)
Patients receive pembrolizumab IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and berzosertib IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab IV over 30 minutes on day 1 and berzosertib IV over 60 minutes on days 2 and 9. Cycles repeat every 21 days for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab alone IV over 30 minutes on day 1. Cycles repeat every 6 weeks for up to 1 more year in the absence of disease progression or unacceptable toxicity. Patients undergo MRI scans and/or CT scans, and undergo blood specimen collection on study. |
Given IV
Outros nomes:
Undergo CT
Outros nomes:
Undergo MRI
Outros nomes:
Given IV
Outros nomes:
Given IV
Outros nomes:
Given IV
Outros nomes:
Correlative studies
Outros nomes:
|
|
Comparador Ativo: Arm B (pembrolizumab, gemcitabine, carboplatin)
Patients receive pembrolizumab, gemcitabine, and carboplatin as in Arm A. Patients undergo MRI scans and/or CT scans, and undergo blood specimen collection on study. |
Given IV
Outros nomes:
Undergo CT
Outros nomes:
Undergo MRI
Outros nomes:
Given IV
Outros nomes:
Given IV
Outros nomes:
Correlative studies
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patients Who Experienced a DLT
Prazo: Up to completion of cycle 1
|
Percentage of patients who experienced Dose Limiting Toxicities (DLTs) when treated with carboplatin in combination with berzosertib (M6620, VX-970), per CTCAE v5.0 |
Up to completion of cycle 1
|
|
Recommended Phase 2 Dose (RP2D)
Prazo: Up to completion of cycle 1
|
Determined by the number of patients who experienced Dose Limiting Toxicities (DLTs) when treated with carboplatin in combination with berzosertib (M6620, VX-970), per CTCAE v5.0, DLT is defined as the severe toxicity event that leads to the termination of the treatment. The RP2D is the highest dose level where <2/6 DLTs are observed. |
Up to completion of cycle 1
|
|
12-month Progression-free Survival (PFS) - Total Population
Prazo: At 12 months
|
Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
At 12 months
|
|
24-month Progression-free Survival (PFS) - Total Population
Prazo: At 24 months
|
Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
At 24 months
|
|
Progression-free Survival (PFS) - Total Population
Prazo: Up to 30 months
|
Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Up to 30 months
|
|
12-month Progression-free Survival (PFS) - By Dose Level
Prazo: At 12 months
|
Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
At 12 months
|
|
24-month Progression-free Survival (PFS) - Dose Level 1
Prazo: At 24 months
|
Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
At 24 months
|
|
Progression-free Survival (PFS) - By Dose Level
Prazo: Up to 30 months
|
Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Up to 30 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Best Overall Response - Total Population
Prazo: Up to 12 months post treatment
|
Percentage of patients with Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Up to 12 months post treatment
|
|
Best Overall Response - By Dose Level
Prazo: Up to 12 months post treatment
|
Percentage of patients with Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Up to 12 months post treatment
|
|
12-month Overall Survival (OS) - Total Population
Prazo: At 12 months
|
Percentage of patients alive from start of treatment. |
At 12 months
|
|
24-month Overall Survival (OS) - Total Population
Prazo: At 24 months
|
Percentage of patients alive from start of treatment. |
At 24 months
|
|
Overall Survival (OS) - Total Population
Prazo: Up to 30 months post treatment
|
Median number of months that patients remain alive from start of treatment. |
Up to 30 months post treatment
|
|
12-month Overall Survival (OS) - By Dose Level
Prazo: At 12 months
|
Percentage of patients alive from start of treatment. |
At 12 months
|
|
24-month Overall Survival (OS) - By Dose Level
Prazo: At 24 months
|
Percentage of patients alive from start of treatment. |
At 24 months
|
|
Overall Survival (OS) - By Dose Level
Prazo: Up to 30 months post treatment
|
Median number of months that patients remain alive from start of treatment. |
Up to 30 months post treatment
|
|
Worst Grade of Adverse Events
Prazo: Up to 12 months post treatment
|
Number of patients with adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, determined to be at least possibly related to treatment. |
Up to 12 months post treatment
|
|
PFS in Ataxia Telangiectasia Mutated (ATM)-Deficient Sq-NSCLC
Prazo: Up to 30 months
|
Progression Free Survival in ataxia telangiectasia mutated (ATM)-deficient Sq-NSCLC. Median PFS estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Up to 30 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Determination if Features of Whole Exome and Ribonucleic Acid (RNA) Sequencing Are Predictive OR, OS, or PFS
Prazo: Up to 12 months post treatment
|
Sparse modeling (e.g., the lasso) will be used to determine if any features of whole exome and RNA sequencing are predictive of OR, OS or PFS. |
Up to 12 months post treatment
|
|
ATM Assay
Prazo: Up to 12 months post treatment
|
Proportional hazards (Cox) regression will be used to assess the relationship between the ATM assay and OS and PFS. |
Up to 12 months post treatment
|
|
Inflammation-associated Gene Signatures
Prazo: Up to 12 months post treatment
|
Logistic regression and proportional hazards (Cox) regression will be used to explore the relationship between inflammation-associated gene signatures and OR, OS, and PFS. |
Up to 12 months post treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Liza C Villaruz, University of Pittsburgh Cancer Institute LAO
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças Respiratórias
- Doenças pulmonares
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Neoplasias Pulmonares
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Técnicas de investigação
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Complexos de coordenação
- Desoxicitidina
- Citidina
- Nucleosídeos de pirimidina
- Pirimidinas
- Técnicas de química, analíticas
- Análise de espectro
- Gemcitabina
- Carboplatina
- Manipulação de amostras
- Pembrolizumab
- Espectroscopia de ressonância magnética
- Berzosertib
Outros números de identificação do estudo
- NCI-2019-08660
- UM1CA186690 (Concessão/Contrato do NIH dos EUA)
- 20-134
- 10313 (Outro identificador: CTEP)
- NCI-2019-08660 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 10313 (Outro identificador: UPMC Hillman Cancer Center LAO)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .