SHR-A2102 combined with other anti-cancer therapies around surgery for resectable non-small cell lung cancer
Official title: 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
Run by Shanghai Hengrui Pharmaceutical Co., Ltd. · NCT07229729 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | November 24, 2025 |
| Main results expected | October 2026 |
| Study ends | October 2029 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07229729 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Neoadjuvant immunotherapy combined with chemotherapy has shown improved pathological response in prior studies, but combinations including SHR-A2102 are novel and not yet established.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Junli Wang
- Email: junli.wang@hengrui.com
- Phone: +86-0518-82342973
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Patient-specific MRD liquid biopsy for resected NSCLC
This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.
-
Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases
This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.
-
Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies
This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.
-
SI-B036 safety test in advanced and metastatic solid tumors
This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.
-
Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery
This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.
-
HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC
This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.