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임상시험 NCT07393555은(는) 재발성 비소세포 폐암, 4기 폐암 AJCC v8에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial) 2상 117 표적 치료 단일 클론 항체
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07393555은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 재발성 비소세포 폐암, 4기 폐암 AJCC v8에 대해 진행되며, 2상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 8월 7일부터 가능하며, 117명의 참여자를 모집할 예정입니다. SWOG Cancer Research Network이(가) 진행하는 이 연구는 2029년 11월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 6일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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...
더 보기공식 제목
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)
질환명
재발성 비소세포 폐암4기 폐암 AJCC v8기타 연구 식별자
- S1900N
- NCI-2026-00250 (등록 식별자) (CTRP (Clinical Trial Reporting Program))
- S1900N (기타 식별자) (SWOG)
- S1900N (기타 식별자) (CTEP)
- U10CA180888 (NIH (미국 국립보건원) 보조금/계약)
NCT 번호
실제 연구 시작일
2026-08-07
최신 업데이트 게시
2026-02-06
예상 연구 완료일
2029-11
계획된 등록 인원
117
연구종류
중재연구
단계/상
2상
상태
대상자모집전
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Arm 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. | 생체 시료 수집 Undergo collection of blood samples 컴퓨터 단층 촬영 Undergo CT Ivonescimab Given IV 자기 공명 영상 Undergo MRI Sacituzumab Govitecan Given IV |
실험적Arm 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. | 생체 시료 수집 Undergo collection of blood samples 컴퓨터 단층 촬영 Undergo CT 자기 공명 영상 Undergo MRI Sacituzumab Govitecan Given IV |
실험적Arm 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. | 생체 시료 수집 Undergo collection of blood samples 컴퓨터 단층 촬영 Undergo CT Ivonescimab Given IV 자기 공명 영상 Undergo MRI |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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
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시험기관의 위치 정보가 없습니다.