SHR-A2102 combined with other anti-cancer therapies around surgery for resectable non-small cell lung cancer

A Randomized, Open-label, Multicenter Phase II Clinical Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer

This trial will test SHR-A2102 given with other anti-cancer drugs around the time of surgery in adults with resectable non-small cell lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07229729 on ClinicalTrials.gov

What this trial studies

This Phase II, single-center study tests SHR-A2102 in combination with other anti-tumor therapies as a perioperative (neoadjuvant and/or adjuvant) treatment for patients with resectable non-small cell lung cancer. Participants receive combinations that may include SHR-A2102, adebrelimab, paclitaxel plus carboplatin, and almonertinib mesilate according to the protocol, followed by surgical resection and post‑operative follow-up. Key eligibility includes adults aged 18–70 with ECOG performance status 0–1, adequate organ function, and negative pregnancy test for women of childbearing potential. Major exclusions include active autoimmune disease, other recent malignancies, significant pre-existing lung disease or prior pneumonitis, and the study is sponsored by Shanghai Hengrui Pharmaceutical and enrolling at Guangdong Provincial People's Hospital.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 with resectable NSCLC, ECOG 0–1, adequate organ function, and willingness to use effective contraception if of childbearing potential.

Not a fit: Patients with active autoimmune disease, recent other cancers, severe lung disease or unresectable disease are unlikely to benefit or may be ineligible for this protocol.

Why it matters

Potential benefit: If successful, this approach could shrink tumors before surgery and reduce recurrence risk, potentially improving long-term outcomes for patients with resectable NSCLC.

How similar studies have performed: Neoadjuvant immunotherapy combined with chemotherapy has shown improved pathological response in prior studies, but combinations including SHR-A2102 are novel and not yet established.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Junli Wang

Conditions Non-small Cell Lung Cancer