Not Yet RecruitingPhase 2

RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

108 participantsStarted 2024-02-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age: 18 (inclusive) or above, regardless of gender.
✓. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).".
✓. HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression;
✓. Number of treatment lines:
✓. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
✓. ECOG fitness status score: 0 or 1 point.

Exclusion criteria

✕. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
✕. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
✕. Have a history of severe cardiovascular disease.
✕. Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia.
✕. Have a history of neurological disorders or mental illnesses, including epilepsy or dementia.
✕. Pregnant or lactating women.
✕. The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.

What they're measuring

Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

Timeframe: Up to 24 months (data cut-off)

Trial details

NCT IDNCT06185400

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

Contact for this trial

Jie Wang, Dr

010-87788219 zlhuxi@163.com

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials