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Advanced or Metastatic Non-small Cell Lung CancerPhase 1/2NCT06512051

A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 1/2 study testing SHR-A2102 for Injection, Adebrelimab Injection and Cisplatin injection in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
SHR-A2102 for Injection, Adebrelimab Injection and Cisplatin injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteChina
Study dates
30 Jul 2024to Oct 2026
Phase
Phase 1/2
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

  • Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements.
  • The age of signing the informed consent is 18 -70 years, regardless of gender.
  • Provide archived or fresh tumor tissue for vendor test.
  • At least one measurable lesion according to RECIST v1.1 criteria.
  • Patients with locally advanced or metastatic non-small cell lung cancer who have been confirmed by histological or cytological examination to be inoperable and unable to undergo radical radiotherapy or chemotherapy.
  • The ECOG score is 0 or 1.
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  • Expected survival ≥12 weeks.
  • Good level of organ function.
  • Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Who cannot join

  • Active or symptomatic brain metastases.
  • With the exception of patients diagnosed with any other malignancy, except those who have achieved complete remission at least 5 years prior to screening and have ended adjuvant therapy, can be treated locally and have a clear medical record of cure, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer in situ, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary carcinoma of the thyroid.
  • Uncontrollable moderate to large amounts of pleural effusion, peritoneal effusion or pericardial effusion.
  • Patients with uncontrolled tumor-related pain .
  • Have antitumor therapy was received 4 weeks before the start of the study.
  • Perform non-chest radiation therapy with >30 Gy within 28 days before dosing, chest radiation therapy with >30 Gy within 24 weeks before first dosing, and radiation therapy with ≤30 Gy within 14 days before first dosing.
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  • Subjects who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or the 5 half-life of the investigational drug, whichever is longer.
  • Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period.
  • Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria
  • Systemic immunosuppressive therapy was administered within 14 days prior to the first study.
  • Subjects with a prior history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, and currently known or suspected interstitial pneumonia/non-infectious pneumonia.
  • The presence of any active, known or suspected autoimmune disease.
  • Subjects with severe cardiovascular and cerebrovascular diseases.
  • Subjects who had a severe infection within 28 days prior to the first dose
  • Active hepatitis B or active hepatitis C.
  • Patients with active pulmonary tuberculosis within 1 year prior to enrolment.
  • Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication
  • History of immune deficiency
  • Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment；
  • Female subjects who are pregnant or plan to become pregnant during the study period.
  • Uncontrollable mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
  • Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
  • Having a bleeding tendency, a high risk of bleeding, coagulation dysfunction or thrombosis tendency (for patients using bevacizumab).
  • Poorly controlled hypertension (with regular antihypertensive treatment, systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg), as well as previous occurrence of hypertensive crisis or hypertensive encephalopathy (in patients using bevacizumab).
  • Within 6 months prior to the first administration of the medication, had a major vascular disease (for patients using bevacizumab).
  • If within 7 days prior to the first administration of the drug, the patient had used the full dose of oral or injectable anticoagulant or thrombolytic drugs for therapeutic purposes, prophylactic anticoagulation treatment for the open intravenous infusion system is permitted, and prophylactic use of low-molecular-weight heparin (for patients using bevacizumab) is also allowed.
  • Within 7 days prior to the first administration, the patient has used or needs to use aspirin, dipyridamole, ticlopidine, clopidogrel, cilostazol or other drugs that inhibit platelet function (for patients using bevacizumab).
  • Having severe, non-healed wounds, active ulcers or untreated fractures (for patients using bevacizumab).
  • Within 6 months prior to the first administration of the drug, there had been a history of gastrointestinal perforation. During the screening process, clinical symptoms or signs indicated the presence of intestinal obstruction (for patients using bevacizumab).
  • CT/MRI indicated that the tumor surrounded or invaded major blood vessels (for patients who received bevacizumab treatment).
  • Subjects who have previously received systemic treatment with anti-angiogenic drugs such as VEGF/VEGFR inhibitors, including but not limited to bevacizumab, recombinant human endostatin, anlotinib, etc. (patients who used bevacizumab).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yunfei Zhang contact

0518-82342973

yunfei.zhang.yz277@hengrui.com

China1 site, 1 recruiting

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality

    Yi Hu

    Recruiting

Other trials in China

About this study

Official title: A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer.

To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer

Being tested
SHR-A2102 for Injection, Adebrelimab Injection, Cisplatin injection, Carboplatin injection, Bevacizumab Injection
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-A2102 for InjectionDrug

    Drug: SHR-A2102 for injection.

  • Adebrelimab InjectionDrug

    Adebrelimab injection.

  • Cisplatin injectionDrug

    Cisplatin injection.

  • Carboplatin injectionDrug

    Carboplatin injection.

  • Bevacizumab InjectionDrug

    Bevacizumab injection.

Study groups in NCT06512051
Study groupRoleWhat they receive
Treatment group AExperimentalSHR-A2102+Adebrelimab+Cisplatin/Carboplatin
Receives: Drug: SHR-A2102 for Injection; Drug: Adebrelimab Injection; Drug: Cisplatin injection; Drug: Carboplatin injection
Treatment group BExperimentalSHR-A2102+Adebrelimab+Bevacizumab
Receives: Drug: SHR-A2102 for Injection; Drug: Adebrelimab Injection; Drug: Bevacizumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RP2D

    RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages；

    Measured: through phase IB completion, an average of 1 years

  2. Incidence and severity of AE(DLT)

    According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose；

    Measured: from Day1 to 90 days after last dose

  3. ORR

    efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1

    Measured: 18 months after the last subject was enrolled in the group

Secondary outcomes (4)

  1. DCR

    Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；

    Measured: 18 months after the last subject was enrolled in the group

  2. DOR

    Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；

    Measured: 18 months after the last subject was enrolled in the group

  3. PFS(Investigator evaluation)

    Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；

    Measured: 18 months after the last subject was enrolled in the group

  4. OS(Investigator evaluation)

    Since C1D1 and death from any cause；

    Measured: 18 months after the last subject was enrolled in the group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start30 Jul 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06512051
Sponsor's protocol ID
SHR-A2102-205
Status last verified
Dec 2025
First submitted
16 Jul 2024
Last updated
23 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A2102 for Injection, Adebrelimab Injection and Cisplatin injection in people with Advanced or Metastatic 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 9 inclusion and 31 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 23 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Yunfei Zhang (0518-82342973, yunfei.zhang.yz277@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D (time frame: through phase IB completion, an average of 1 years). 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?

On the ClinicalTrials.gov record for NCT06512051.

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 23 Dec 2025.

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