SHR-A1811 with Pyrotinib or SHR-1316 for Lung Cancer

A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer

Recruiting Phase 1 Phase 2 Interventional Study
Advanced Non-small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
324 (estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
Who this trial is looking for

This trial is looking for people with advanced non-small cell lung cancer. Participants will receive SHR-A1811 along with other treatments to see how well it works.

Are You a Good Fit for This Trial?
Rules you out Central nervous system metastasesActive infectionSevere cardiovascular diseaseActive hepatitis BActive tuberculosis

You may be able to join if

  • I am between 18 and 75 years old.
  • I have advanced or metastatic non-small cell lung cancer.
  • I can provide a tumor tissue sample.
  • I have at least one measurable lesion.
  • I have an ECOG score of 0 or 1.
  • I agree to use birth control during the study.
  • I can give informed consent and follow study requirements.
  • I expect to live at least 12 weeks.

You may not be able to join if

  • I have untreated or active central nervous system tumor metastases.
  • I had any significant fluid buildup requiring treatment in the last week.
  • I had systemic antitumor therapy in the last 4 weeks.
  • I received chest radiation over 30 Gy in the last 6 months.
  • I completed palliative radiotherapy in the last week.
  • I am experiencing severe allergic reactions to certain drugs.
  • I have an active infection or severe health issues.
  • I participated in another clinical study less than 4 weeks ago.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements 2. When signing the informed consent, the age is 18-75 years old (including both ends), and …
Contacts

Suqiang Yu

+0518-82342973

suqiang.yu@hengrui.com

CONTACT