NCT05358548招募中2 期
Alternating Treatment Plans for Participants With Advanced Thoracic/Head & Neck Cancers (ATATcH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 21
- 主要终点
- Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles
研究概览
简要总结
The purpose of the research is to evaluate a new schedule of alternating cycles of induction chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab) alone for the initial treatment of patients with advanced lung or head and neck cancers.
详细描述
This study is looking at the effect of alternating combination chemotherapy plus immunotherapy with immunotherapy alone during the induction phase (resulting in less frequent use of chemotherapy, once every six weeks instead of the usual every three weeks during induction) on the ability to fight your tumor. We expect that less frequent exposure to chemotherapy in this setting will control your cancer effectively while preserving your quality of life.
The primary endpoint of this three-arm, parallel phase II study is the percentage of patients receiving one, two, three and four (up to six for patients with head and neck cancer) combination chemoimmunotherapy cycles. Along with, overall response rates at six weeks and the best response rate. Additionally, to record the safety and tolerability of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lung Cancer (Arms 1 and 2)
- •Patients must have histologically or cytologically confirmed stage IV NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition). Patients with Stage IIIB and IIIC disease are eligible if they are not candidates for combined chemotherapy and radiation; such cases should be discussed in a multidisciplinary tumor board.
- •Eligible NSCLC tissue histologies will include squamous cell carcinoma (enrolled and treated in Arm 1), and nonsquamous histologies (e.g. adenocarcinoma, large cell carincoma, etc.; enrolled and treated in Arm 2). Patients with mixed squamous, e.g., adenosquamous, histology will be enrolled and treated on Study Arm
- •Patients with any evidence of Small Cell Carcinoma will be excluded from study participation.
- •Patients may have ANY PD-L1 expression Tumor Proportion Score (TPS) status. Tissue testing for PD-L1 is strongly recommended. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patient may still be eligible.
- •Patients must have measurable or non-measurable disease. The presence of malignant pleural fluid alone is sufficient to satisfy this eligibility criterion. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration. NOTE: If patient receives pemetrexed, follow institutional guidelines to drain fluids.
- •Patients must be ≥ 18 years of age.
- •Patients must have an ECOG Performance Status of 0 to 2
- •Patients must NOT have received the following:
- •Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible. Chemotherapy and immunotherapy for non-metastatic disease (e.g. adjuvant therapy) or immunotherapy for locally advanced Stage III disease is allowed if at least 6 months have elapsed between the last dose of the prior therapy and study registration. Local therapy, e.g. palliative radiation, is allowed as long as a period of 7 days has passed between completion of local therapy and study registration. Registration prior to treatment during the 7 days is allowed. Palliative radiation must be to non-target lesions.
- •Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.
- •For Arm 1 (Squamous Lung Cancer): Patients must not have pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v.5.
- •Patients must not have known sensitivity to any component of carboplatin or paclitaxel or nabpaclitaxel.
- •Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600), MET Exon14 skipping or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded.
- •Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with asymptomatic new (at screening) or progressive brain metastases (active brain metastases at screening) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
- •Patients are eligible if off steroids for at least 7 days prior to protocol treatment.
- •Palliative radiation to non-target lesions (bone metastasis) is allowed if patient develops symptoms.
- •Anticonvulsants are allowed.
- •Patients with asymptomatic, sub-centimeter brain metastasis who at the discretion of investigators do not need immediate CNS directed therapies are eligible.
- •Patients with 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 must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
- •Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g. Crohn's disease, malabsorption, etc.)
- •Patients must not have history of auto-immune condition requiring ongoing or intermittent 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.
- •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 II or better.
- •Patients must not have any other concomitant serious illness or organ system dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug.
- •Patients must not receive any other investigational agents during the course of therapy.
- •Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk of MK-3475 (pembrolizumab). Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least 120 days after the last dose of study treatment.
- •All females of childbearing potential must have a blood test or urine study within 72 hours prior to registration to rule out pregnancy.
- •A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- •Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or abstain from sexual intercourse from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment.
- •Patient must have the ability to understand and the willingness to sign a written informed consent document.
- •Patients must meet the following laboratory values within 14 days of randomization:
- •ANC ≥ 1500/mm3
- •Platelets ≥ 100,000/mm3
- •Hgb > 8 g/dL (Note: Patient may be transfused to meet this criteria)
- •PT/INR ≤ 1.5
- •Or if patient on therapeutic anticoagulation with Warfarin, PT/INR ≤ 3.0
- •Patients must have adequate liver function as determined by the following tests obtained within 14 days of randomization:
- •Total Bilirubin ≤ 1.5 mg/dL
- •SGOT (AST) < 5X upper limit of normal (ULN)
- •SGPT (ALT) < 5X upper limit of normal ULN)
- •Patients must have adequate renal function as determined by the following tests obtained within 14 days prior to randomization:
- •Calculated creatinine clearance ≥ 45ml/min to be eligible to receive pemetrexed Serum creatinine ≤ 1.5X institutional upper limit of normal (ULN)
- •Patients must not have a known history of active tuberculosis (TB).
- •Patients must not have a diagnosis of immunodeficiency or receive systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol treatment.
- •Patients must not have received a live vaccine within 30 days prior to randomization. Seasonal flu vaccines that do not contain live virus are permitted. COVID-19 vaccination per guidelines for cancer patients is permitted and encouraged.
- •Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- •For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must 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.
- •Head and Neck Cancer (Arm 3)
- •Patient must have histologically confirmed recurrent/metastatic squamous cell carcinoma of the head and neck (HNSCC) (excluding SCC of salivary glands, nasopharynx and skin) that is considered incurable by local therapies. The eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. Unknown primary site will also be considered eligible.
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排除标准
- 未提供
研究组 & 干预措施
Squamous Lung Cancer
Experimental
A Cycles consist of either:
- Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR
- nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard)
B Cycles consist of Pembrolizumab alone
干预措施: Paclitaxel (Drug)
Squamous Lung Cancer
Experimental
A Cycles consist of either:
- Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR
- nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard)
B Cycles consist of Pembrolizumab alone
干预措施: Carboplatin (Drug)
Squamous Lung Cancer
Experimental
A Cycles consist of either:
- Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR
- nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard)
B Cycles consist of Pembrolizumab alone
干预措施: Pembrolizumab (Drug)
Non-Squamous Lung Cancer
Experimental
- A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard)
- B Cycles consist of Pembrolizumab alone
Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard)
干预措施: Pemetrexed (Drug)
Non-Squamous Lung Cancer
Experimental
- A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard)
- B Cycles consist of Pembrolizumab alone
Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard)
干预措施: Pembrolizumab (Drug)
Head and Neck Squamous Cell Carcinoma
Experimental
- A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard)
- B Cycles consist of Pembrolizumab alone
Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard)
干预措施: 5Fluorouracil (Drug)
Head and Neck Squamous Cell Carcinoma
Experimental
- A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard)
- B Cycles consist of Pembrolizumab alone
Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard)
干预措施: Carboplatin (Drug)
Head and Neck Squamous Cell Carcinoma
Experimental
- A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard)
- B Cycles consist of Pembrolizumab alone
Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard)
干预措施: Pembrolizumab (Drug)
Non-Squamous Lung Cancer
Experimental
- A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard)
- B Cycles consist of Pembrolizumab alone
Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard)
干预措施: Carboplatin (Drug)
结局指标
主要结局
Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles
时间窗: up to 30 weeks
The primary endpoint of this three-arm, parallel phase II study is the percentage of patients in each of the study arms receiving 1, 2, 3 and 4 (up to 6 cycles for head and neck cancer) induction combination chemoimmunotherapy (termed "A") cycles (reflecting timepoints of 0, six weeks, twelve weeks, and eighteen weeks on study, respectively \[up to 30 weeks for patients with head and neck cancer\]).
次要结局
- Overall response rates(4 week prior to initial treatment and at six week follow -up time point)
- Progression Free Survival(36 months)
- Safety as assessed by number of participants experiencing adverse events(36 months)
研究者
Missak Haigentz, MD
Professor of Medicine
Rutgers, The State University of New Jersey
研究点 (21)
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