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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

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 escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.

Eligibility criteria

Qualifiers

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

When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation

The ECOG score is 0 or 1

The expected survival is ≥12 weeks

Disqualifiers

There are untreated or active central nervous system (CNS) tumor metastases

Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration

Systemic antitumor therapy was performed 4 weeks prior to study initiation

Prior treatment with antibody-conjugated drugs

Trial design

Treatments tested in this trial

  • SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316

Treatment groups

324 Participants
are divided into 1 treatment group