Non-small Cell Lung CancerPhase 2NCT07229729
A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer
A Phase 2 study testing SHR-A2102, Adebrelimab and Paclitaxel in people with Non-small Cell Lung Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- SHR-A2102, Adebrelimab and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2025to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in writing;
- Participants must be aged between 18 and 70 years old (inclusive) when signing the informed consent form, and both men and women are eligible;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Adequate organ function;
- 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.
Who cannot join
- With active, known or suspected autoimmune disease of autoimmune disease;
- Malignancies other than NSCLC within 5 years prior to randomization;
- Has or suspected has a history of pneumonitis / interstitial lung disease or any serve lung diseases which will influence the examination of lung function;
- Significant history of cardiovascular and cerebrovascular disease; Significant haemorrhagic disease;
- Has an arteriovenous thrombotic events;
- Has a known history of human immunodeficiency virus (HIV) infection;
- Has a known active Hepatitis B or Hepatitis C;
- Allergic to the intervention regimens.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yilong Wu, +86-020-83827812, syylwu@live.cn
Yilong Wu
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- SHR-A2102, Adebrelimab, Paclitaxel, Carboplatin, Alomnertinib Mesilate
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102Drug
SHR-A2102.
AdebrelimabDrug
Adebrelimab.
PaclitaxelDrug
Paclitaxel.
CarboplatinDrug
Carboplatin.
Alomnertinib MesilateDrug
Alomnertinib Mesilate.
Furmonertini MesilateDrug
Furmonertini Mesilate.
Osimertinib MesylateDrug
Osimertinib Mesylate.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group | Experimental | Not described Receives: Drug: SHR-A2102; Drug: Adebrelimab; Drug: Paclitaxel; Drug: Carboplatin |
| SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group | Active comparator | Not described Receives: Drug: SHR-A2102; Drug: Alomnertinib Mesilate; Drug: Furmonertini Mesilate; Drug: Osimertinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathology complete response (pCR)
Measured: Up to approximately 20 weeks.
18-month event free rate
Measured: Up to approximately 18 months.
2-years disease free rate
Measured: Up to approximately 2 years.
Secondary outcomes (5)
Event free survival (EFS)
Measured: Up to approximately 5 years.
Overall survival (OS)
Measured: Up to approximately 5 years.
Objective response rate (ORR)
Measured: Up to approximately 20 weeks.
Disease-Free Survival (DFS)
Measured: Up to approximately 5 years.
Adverse events (AEs)
Measured: Up to approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start24 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229729
- Sponsor's protocol ID
- SHR-A2102-212
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07229729
- Acronym / sponsor ID
- SHR-A2102-212
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group | Experimental | Drug: SHR-A2102, Drug: Adebrelimab, Drug: Paclitaxel, Drug: Carboplatin |
| SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group | Active comparator | Drug: SHR-A2102, Drug: Alomnertinib Mesilate, Drug: Furmonertini Mesilate, Drug: Osimertinib Mesylate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in writing;
- Participants must be aged between 18 and 70 years old (inclusive) when signing the informed consent form, and both men and women are eligible;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Adequate organ function;
- 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.
Key exclusion criteria (8 listed)
- With active, known or suspected autoimmune disease of autoimmune disease;
- Malignancies other than NSCLC within 5 years prior to randomization;
- Has or suspected has a history of pneumonitis / interstitial lung disease or any serve lung diseases which will influence the examination of lung function;
- Significant history of cardiovascular and cerebrovascular disease; Significant haemorrhagic disease;
- Has an arteriovenous thrombotic events;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A2102SHR-A2102. | Drug | SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group, SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group |
| AdebrelimabAdebrelimab. | Drug | SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group |
| PaclitaxelPaclitaxel. | Drug | SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group |
| CarboplatinCarboplatin. | Drug | SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group |
| Alomnertinib MesilateAlomnertinib Mesilate. | Drug | SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group |
| Furmonertini MesilateFurmonertini Mesilate. | Drug | SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group |
| Osimertinib MesylateOsimertinib Mesylate. | Drug | SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group |
Primary outcome
Pathology complete response (pCR)
Time frame: Up to approximately 20 weeks.
18-month event free rate
Time frame: Up to approximately 18 months.
2-years disease free rate
Time frame: Up to approximately 2 years.
5 secondary outcomes
Event free survival (EFS)
Time frame: Up to approximately 5 years.
Overall survival (OS)
Time frame: Up to approximately 5 years.
Objective response rate (ORR)
Time frame: Up to approximately 20 weeks.
Disease-Free Survival (DFS)
Time frame: Up to approximately 5 years.
Adverse events (AEs)
Time frame: Up to approximately 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A2102, Adebrelimab and Paclitaxel in people with Non-small Cell Lung Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junli Wang (+86-0518-82342973, junli.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology complete response (pCR) (time frame: Up to approximately 20 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.