Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations
This study evaluates the effectiveness and safety of targeted therapy given before and after surgery in patients with resectable or potentially resectable stage III non-small cell lung cancer with selected genetic alterations. Treatment is assigned according to tumor genetic findings.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥18 years.
- Histologically or cytologically confirmed stage III NSCLC (AJCC 8th edition), considered resectable or potentially resectable.
- Documented EGFR exon 20 insertion, ALK fusion, ROS1 fusion, MET exon 14 skipping alteration, RET fusion, or KRAS G12C mutation.
- At least one measurable lesion per RECIST 1.1 and ECOG performance status 0-1.
- Adequate cardiopulmonary and major organ function for surgery.
- Written informed consent and willingness to comply with study procedures, sample collection, and follow-up.
Exclusion Criteria:
- Stage III NSCLC considered unresectable by surgical assessment.
- Lung cancer treatment within the previous 2 years, or prior lung cancer with a remission duration of less than 2 years.
- Another malignancy within the previous 5 years.
- Major surgery within 28 days before the first study dose.
- Any contraindication to the assigned targeted therapy.
- Inability or unwillingness to provide informed consent or comply with study requirements.
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：並列代入
- 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 |
|---|---|
|
実験的：EGFR Exon 20 Insertion Cohort
Sunvozertinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
実験的：ALK Fusion Cohort
Alectinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
実験的：ROS1 Fusion Cohort
Entrectinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
実験的：MET Exon 14 Skipping Cohort
Tepotinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
実験的：RET Fusion Cohort
Selpercatinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
実験的：KRAS G12C Mutation Cohort
Fulzerasib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
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 |
時間枠 |
|---|---|
|
Major Pathological Response Rate
時間枠：At surgery, approximately 10-12 weeks after treatment initiation.
|
At surgery, approximately 10-12 weeks after treatment initiation.
|
協力者と研究者
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。