Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC
Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive Non-small Cell Lung Cancer(NSCLC): An Exploratory Analysis
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Qiming Wang Qiming Wang
- 電話番号：13783590691
- メール：qimingwang1006@126.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Co-hort 1: Strict co-hort Inclusion criteria1：Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer; Inclusion criteria2：Age ≥ 18 years at the time of signing the informed consent form; Inclusion criteria3：ALK-positive status confirmed by tissue samples or blood tests at each centre; Inclusion criteria4：History of resistance to lorlatinib treatment; prior use of ensartinib is not permitted; patients must have received a maximum of two other ALK-TKIs; prior receipt of ≤2 courses of chemotherapy is permitted; ECOG Performance Status (PS) score between 0 and 2, with no deterioration within 2 weeks prior to study entry;
Co-hort 2 (Compassionate Use Cohort):
Inclusion criteria1： Resistance to lorlatinib treatment; Inclusion criteria2： No restrictions on prior use of ensartinib or the number of prior lines of other ALK-TKIs and chemotherapy; Inclusion criteria3：Subjects with concomitant leptomeningeal metastases may be enrolled. For patients with leptomeningeal metastases (LM), diagnosis must be based on the three criteria outlined in the EANO-ESMO guidelines: clinical presentation, cranial imaging, and cerebrospinal fluid cytology. Tissue samples must not be derived from tumour sites that have previously undergone radiotherapy; however, new lesions arising after local treatment may be included; Inclusion criteria4：ECOG performance status of 0-4; Inclusion criteria5： Adequate organ system function, as determined by the investigator; Inclusion criteria6：All other inclusion criteria are consistent with items 1, 2 and 3 of Cohort 1.
Exclusion criteria1：Concurrent malignant tumours. Exclusion criteria2：Patients with leptomeningeal metastases (LM) who are unable to undergo contrast-enhanced MRI.
Exclusion criteria3：Patients who have undergone surgery within 4 weeks prior to treatment with the study drug, except for minor procedures deemed by the investigator not to preclude participation in the trial; or patients scheduled to undergo major surgery during the study period.
Exclusion criteria4：Patients who have experienced a marked deterioration in symptoms or signs within 2 weeks prior to screening and are deemed by the investigator to be unsuitable for participation in the trial.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Strict Queue
Patients with a performance status (ECOG) score of 0-2 and brain parenchymal metastases were enrolled in Cohort 1.
|
Ensatinib is administered at a dose of 225 mg once daily, either on an empty stomach or with food; anlotinib is administered at a dose of 10 mg once daily, in 21-day cycles; treatment continues until disease progression, the occurrence of intolerable toxicity, withdrawal at the discretion of the investigator or the subject, loss to follow-up, initiation of other anticancer therapy, or death.
|
|
他の：Compassionate Use Cohort
Patients with a performance status (ECOG) score of 0-4 and leptomeningeal metastases were enrolled in Cohort 2 (compassionate use cohort).
|
Ensatinib is administered at a dose of 225 mg once daily, either on an empty stomach or with food; anlotinib is administered at a dose of 10 mg once daily, in 21-day cycles; treatment continues until disease progression, the occurrence of intolerable toxicity, withdrawal at the discretion of the investigator or the subject, loss to follow-up, initiation of other anticancer therapy, or death.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective response rate (ORR)
時間枠：After the patients were enrolled according to the inclusion criteria, the tumor assessment will be conducted every 6 weeks, and the maximum duration of the assessment is 6 months until the patients have disease progression or cannot tolerate the treatmen
|
If the patient has available imaging results from within 28 days prior to the first dose (bone scans may be accepted if performed within 2 months prior to the first dose), repeat imaging is not required.
Tumour assessment should be performed every 6 weeks (±4 days) until tumour progression.
|
After the patients were enrolled according to the inclusion criteria, the tumor assessment will be conducted every 6 weeks, and the maximum duration of the assessment is 6 months until the patients have disease progression or cannot tolerate the treatmen
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary endpoints include progression-free survival (PFS)
時間枠：The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete
|
Progression-free survival (PFS): defined as the time from randomisation to the first occurrence of objective tumour progression or death, whichever comes first.
|
The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete
|
|
Overall survival (OS)
時間枠：The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete
|
Overall survival (OS): defined as the time from randomisation to the patient's death from any cause.
|
The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete
|
|
Duration of Response (DOR)
時間枠：The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete
|
Duration of Response (DOR): Defined as the time from the first assessment of complete response (CR) or partial response (PR) until the first assessment of disease progression (PD) or death from any cause.
|
The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete
|
|
Disease Control Rate (DCR)
時間枠：The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete
|
Disease Control Rate (DCR): Defined as the proportion of patients who achieve complete response (CR), partial response (PR) or stable disease (SD) following treatment and maintain this status for a certain period.
|
The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete
|
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Safety assessment
時間枠：At the end of the first cycle (24 days in each cycle), a safety follow-up (telephone follow-up) was conducted within 28 days after the last administration.
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Safety assessment: A summary of patients' physical examinations, electrocardiograms, ECOG scores, vital signs, adverse events and abnormal laboratory test results.
All adverse events should be graded for severity in accordance with NCI CTCAE version 4.03.
|
At the end of the first cycle (24 days in each cycle), a safety follow-up (telephone follow-up) was conducted within 28 days after the last administration.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-252
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