Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

RCVDODIIR010

Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.

2024-02-01

2025-07-01

2026-12-01

Not yet recruiting

Early phase I

108

Inclusion Criteria: 1. Age: 18 (inclusive) or above, regardless of gender. 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).". 3. HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression; 4. Number of treatment lines: * Arm1: patients who have not previously received systemic treatment for advanced diseases; * Arm2: Previously received first line of third-generation EGFR-TKIs treatment with local progression, oligometastasis, or slow progression, and evaluated by the researchers to continue to benefit from third-generation EGFR-TKIs treatment; * Arm3: Previously received first line of third-generation EGFR-TKIs treatment with extensively progression, and evaluated by the researchers not likely to continue to benefit from third-generation EGFR-TKIs treatment; 5. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline. 6. ECOG fitness status score: 0 or 1 point. Exclusion Criteria: 1. Central nervous system metastasis or meningeal metastasis with clinical symptoms. 2. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients. 3. Have a history of severe cardiovascular disease. 4. Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia. 5. Have a history of neurological disorders or mental illnesses, including epilepsy or dementia. 6. Pregnant or lactating women. 7. The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}

2023-12-29