Alternating Treatment Plans for Participants With Advanced Thoracic/Head & Neck Cancers (ATATcH)
概览
- 阶段
- 2 期
- 干预措施
- Paclitaxel
- 疾病 / 适应症
- Head and Neck Cancer
- 发起方
- Rutgers, The State University of New Jersey
- 入组人数
- 150
- 试验地点
- 21
- 主要终点
- Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles
- 状态
- 招募中
- 最后更新
- 前天
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.
研究者
Missak Haigentz, MD
Professor of Medicine
Rutgers, The State University of New Jersey
入排标准
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.
排除标准
- 未提供
研究组 & 干预措施
Squamous Lung Cancer
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
Squamous Lung Cancer
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
Squamous Lung Cancer
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
Non-Squamous Lung Cancer
* 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
Non-Squamous Lung Cancer
* 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
Head and Neck Squamous Cell Carcinoma
* 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
Head and Neck Squamous Cell Carcinoma
* 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
Head and Neck Squamous Cell Carcinoma
* 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
Non-Squamous Lung Cancer
* 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
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)