A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Furmonertini Mesilate; Drug: Alomnertinib Mesilate; Drug: Osimertinib Mesylate; Drug: Adebrelimab; Drug: Carboplatin; Drug: SHR-A2102; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229729

SHR-A2102-212

Details and patient eligibility

About

The study is a Phase II study to explore the efficacy and safety of SHR-A2102 in combination with other anti-tumor therapies as perioperative treatment in patients with resectable non-small cell lung cancer.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in writing;
2. Participants must be aged between 18 and 70 years old (inclusive) when signing the informed consent form, and both men and women are eligible;
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
4. Adequate organ function;
5. Women of childbearing age must undergo serum pregnancy tests, and the results must be negative. Female subjects of childbearing age and male subjects who are partners of women of childbearing age must agree to use highly effective contraceptive methods.

Exclusion criteria

1. With active, known or suspected autoimmune disease of autoimmune disease;
2. Malignancies other than NSCLC within 5 years prior to randomization;
3. Has or suspected has a history of pneumonitis / interstitial lung disease or any serve lung diseases which will influence the examination of lung function;
4. Significant history of cardiovascular and cerebrovascular disease; Significant haemorrhagic disease;
5. Has an arteriovenous thrombotic events;
6. Has a known history of human immunodeficiency virus (HIV) infection;
7. Has a known active Hepatitis B or Hepatitis C;
8. Allergic to the intervention regimens.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group

Experimental group

Treatment:

Drug: Paclitaxel

Drug: SHR-A2102

Drug: Carboplatin

Drug: Adebrelimab

SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group

Active Comparator group

Treatment:

Drug: SHR-A2102

Drug: Osimertinib Mesylate

Drug: Alomnertinib Mesilate

Drug: Furmonertini Mesilate