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治験 NCT07393555（対象：再発肺非小細胞癌、ステージIV肺がん AJCC v8）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial) 第II相・フェーズ2 117 分子標的薬 モノクローナル抗体
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治験番号 NCT07393555 は 治療 の研究で、再発肺非小細胞癌、ステージIV肺がん AJCC v8 に関するものです。この 第II相・フェーズ2 介入研究 臨床試験 は現在 募集準備中 で、2026年8月7日 に開始予定です。117 名の参加者 の募集が計画されています。この試験は SWOG Cancer Research Network によって主導され、2029年11月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月6日 です。
概要
This phase II Expanded Lung-MAP treatment trial compares how well sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan in combination with ivonescimab works in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or is stage IV and has a change in at least 1 of these genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1. This typ...もっと見る
詳細説明
PRIMARY OBJECTIVES:
I. To compare progression-free survival (PFS) between participants randomized to the combination of sacituzumab govitecan plus ivonescimab (SG-I) and sacituzumab govitecan (SG) alone. (Comparison between arms) II. To compare progression-free survival (PFS) between participants randomized to SG-I and ivonescimab (I) alone. (Comparison between arms) III. To evaluate the response (confirmed and unco...
もっと見る公式タイトル
A Randomized Phase II Study of Sacituzumab Govitecan Alone, Ivonescimab Alone, or Sacituzumab Govitecan and Ivonescimab in Participants With Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
疾患名
再発肺非小細胞癌ステージIV肺がん AJCC v8その他の研究識別子
- S1900N
- NCI-2026-00250 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- S1900N (その他の識別子) (SWOG)
- S1900N (その他の識別子) (CTEP)
- U10CA180888 (米国NIHの助成金/契約)
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm 1 (ivonescimab, sacituzumab govitecan) Patients receive ivonescimab IV over 1-2 hours on day 1 of each cycle and sacituzumab govitecan IV over 1-3 hours on day 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the study. | 生体試料採取 Undergo collection of blood samples コンピュータ断層撮影 Undergo CT Ivonescimab Given IV 磁気共鳴画像法 Undergo MRI Sacituzumab Govitecan Given IV |
実験的Arm 2 (sacituzumab govitecan) Patients receive sacituzumab govitecan IV over 1-3 hours on day 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the study. | 生体試料採取 Undergo collection of blood samples コンピュータ断層撮影 Undergo CT 磁気共鳴画像法 Undergo MRI Sacituzumab Govitecan Given IV |
実験的Arm 3 (ivonescimab) Patients receive ivonescimab IV over 1-2 hours on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the study. | 生体試料採取 Undergo collection of blood samples コンピュータ断層撮影 Undergo CT Ivonescimab Given IV 磁気共鳴画像法 Undergo MRI |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Progression-free survival (PFS) (Comparison between arms) | Will compare between participants randomized to the combination of sacituzumab govitecan plus ivonescimab (SG-I) and sacituzumab govitecan (SG) alone. The comparison of PFS will be done using a 1-sided 10% level log-rank test stratified by randomization stratification factors. Binary proportions along with 90% confidence intervals will be estimated for response to be consistent with 1-sided 5% level testing. With 35 participants per arm, binary proportions can be estimated to within 11% with 90% confidence. The distribution PFS will be estimated using the method of Kaplan-Meier. Comparisons of event time distributions between arms will be summarized by hazard ratios and 80% confidence intervals (consistent with 1-sided 10% level testing) from a Cox Proportional hazards model including the stratification factors. | From date of randomization to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years |
PFS (Comparison between arms) | Will between participants randomized to SG-I and ivonescimab (I) alone. The comparison of PFS will be done using a 1-sided 10% level log-rank test stratified by randomization stratification factors. Binary proportions along with 90% confidence intervals will be estimated for response to be consistent with 1-sided 5% level testing. With 35 participants per arm, binary proportions can be estimated to within 11% with 90% confidence. The distribution PFS will be estimated using the method of Kaplan-Meier. Comparisons of event time distributions between arms will be summarized by hazard ratios and 80% confidence intervals (consistent with 1-sided 10% level testing) from a Cox Proportional hazards model including the stratification factors. | From date of randomization to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years |
Response rate of SG against historical response rates (Single arm evaluation) | Within each treatment arm, the objective is to evaluate if response rates show activity beyond standard of care, which generally would be single agent chemotherapy or docetaxel combined with ramucirumab. With 35 eligible and evaluable participants per arm, the evaluation has 90% exact power to rule out a 10% response rate using a 1-sided 5% level test (the exact level is 5.1% based on design assumptions), if the true response rate were at least 29%. The observation of at least 7 participants with a response (a 20% response rate) would be considered evidence to rule out a 10% response rate. | Up to 3 years |
Response rate of I against historical response rates (Single arm evaluation) | Within each treatment arm, the objective is to evaluate if response rates show activity beyond standard of care, which generally would be single agent chemotherapy or docetaxel combined with ramucirumab. With 35 eligible and evaluable participants per arm, the evaluation has 90% exact power to rule out a 10% response rate using a 1-sided 5% level test (the exact level is 5.1% based on design assumptions), if the true response rate were at least 29%. The observation of at least 7 participants with a response (a 20% response rate) would be considered evidence to rule out a 10% response rate. | Up to 3 years |
Response rate of SG-I against historical response rates (Single arm evaluation) | Within each treatment arm, the objective is to evaluate if response rates show activity beyond standard of care, which generally would be single agent chemotherapy or docetaxel combined with ramucirumab. With 35 eligible and evaluable participants per arm, the evaluation has 90% exact power to rule out a 10% response rate using a 1-sided 5% level test (the exact level is 5.1% based on design assumptions), if the true response rate were at least 29%. The observation of at least 7 participants with a response (a 20% response rate) would be considered evidence to rule out a 10% response rate. | Up to 3 years |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Rate of dose-limiting toxicities among participants treated with SG-I in the safety run-in analysis population | Defined as treatment-related Grade 3 or higher non hematologic toxicity, treatment-related Grade 4 or higher hematologic toxicity, or any Grade of treatment-related toxicity that leads to drug discontinuation. Toxicities will be graded based on Common Terminology Criteria for Adverse Events (CTCAE). | During the first cycle of treatment (21 days) |
Response rates | Will compare response rates between I with or without SG. | Up to 3 years |
Response rates | Will compare response rates between SG with or without I. | Up to 3 years |
Overall survival (OS) | Will compare between the SG-I and SG arms. The distribution of OS will be estimated using the method of Kaplan-Meier. Comparisons of event time distributions between arms will be summarized by hazard ratios and 80% confidence intervals (consistent with 1-sided 10% level testing) from a Cox Proportional hazards model including the stratification factors. | From date of randomization to date of death due to any cause, assessed up to 3 years |
OS | Will compare between the SG-I and I arms. The distribution of OS will be estimated using the method of Kaplan-Meier. Comparisons of event time distributions between arms will be summarized by hazard ratios and 80% confidence intervals (consistent with 1-sided 10% level testing) from a Cox Proportional hazards model including the stratification factors. | From date of randomization to date of death due to any cause, assessed up to 3 years |
Duration of response (DoR) | The distribution of DoR will be estimated using the method of Kaplan-Meier. | From date of first documentation of response to date of first documentation of progression, symptomatic deterioration, or death due to any cause among participants who achieve a response, assessed up to 3 years |
Central nervous system (CNS) PFS | CNS progression is defined as the development of new CNS metastasis or progression of CNS disease requiring either local CNS therapy or a change in systemic cancer therapy. The distribution of CNS PFS will be estimated using the method of Kaplan-Meier. Comparisons of event time distributions between arms will be summarized by hazard ratios and 80% confidence intervals (consistent with 1-sided 10% level testing) from a Cox Proportional hazards model including the stratification factors. | From date of randomization to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years |
Frequency and severity of toxicities | Toxicities will be graded based on Common Terminology Criteria for Adverse Events (CTCAE). Toxicities will be summarized as proportions by item and worst grade reported, among those possible, probably, or likely related to treatment and also grouped overall and as hematologic and non-hematologic toxicities. Any toxicity, with at least 10% true prevalence has a 97% chance of being observed. | During the first cycle of treatment (21 days) |
Clinical outcomes by EGFR subgroups | Subgroup analyses will be done using a Cox proportional hazards model for time-to-event outcomes and logistic regression for binary endpoints. | Up to 3 years |
Clinical outcomes by PD-L1 expression subgroups | Subgroup analyses (PD-L1 expression \[\< 1% vs 1% or greater\]) will be done using a Cox proportional hazards model for time-to-event outcomes and logistic regression for binary endpoints. | Up to 3 years |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Participants must have been assigned to S1900N by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900N is determined by submission of documentation of NSCLC harboring an actionable genomic alteration (AGA) in the LUNGMAP protocol. AGA is defined in this protocol as an activating driver alteration with an approved targeted therapy for lung cancer in one of the following genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1.
- Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to randomization.
- Participants must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to randomization.
- Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (≤ 10 mg daily prednisone or equivalent) prior to randomization. Participants with spinal cord compression or brain metastases that require local treatment must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to randomization.
- Participants must not have leptomeningeal disease that requires CNS-specific treatment prior to randomization and must not be planning to receive the CNS-specific treatment while on study.
- Participants must have progressed (in the opinion of the treating physician) during or following the most recent line of systemic therapy.
- Participants must have previously received an appropriate targeted therapy for the lung cancer AGA (ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1).
- Participants must have previously received platinum-based chemotherapy for stage IV or recurrent disease.
- Participants must have received no more than (<=) 3 lines of prior cytotoxic therapy (including chemotherapy, antibody-drug conjugates) for NSCLC.
- Participants must not have received prior TROP2-targeted antibody-drug conjugate or a systemic therapy containing sacituzumab govitecan/SN-38.
- Participants must not have received prior anti-PD-1 or anti-PD-L1 antibody therapy.
- Participants must not have received any systemic lung cancer therapy (except orally administered drugs) within 21 days prior to randomization. Orally administered lung cancer therapies must not have been administered within 10 days prior to randomization.
- Participants must have completed any prior radiation therapy within 7 days prior to randomization.
- Participants must have recovered (≤ Grade 1) from any side effects of prior therapy (except for alopecia) prior to randomization.
- Participants must not be planning to receive any concurrent systemic therapy (e.g. chemotherapy, immunotherapy, targeted therapy etc) for lung cancer treatment while receiving treatment on this study.
- Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to randomization.
- Participants must have a complete medical history and physical exam within 28 days prior to randomization.
- Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to randomization)
- Hemoglobin >= 10.0 g/dL (within 28 days prior to randomization)
- Platelets ≥ 100 x 10^3/uL (within 28 days prior to randomization)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to randomization). Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN
- Participants must have calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to randomization.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better.
- Participants must not have experienced an arterial or venous thrombotic event or hemoptysis within 28 days prior to randomization.
- Participants must not be planning to receive warfarin (or other coumadin derivatives) while receiving treatment on this study.
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
- Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization.
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization.
- Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
- Participants must be offered the opportunity to participate in specimen banking
SWOG Cancer Research Networkアメリカ国立がん研究所連絡先情報がありません。
位置情報がありません。