New drug cocktail aims to shrink Hard-to-Treat lung tumors
NCT ID NCT06512051
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called SHR-A2102 combined with the immunotherapy adebrelimab, with or without chemotherapy or bevacizumab, in 248 people with advanced or metastatic non-small cell lung cancer. The goal is to find the safest dose and see if the combination can shrink tumors. Participants must have measurable tumors and provide a tissue sample.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-A2102 (a targeted drug) combined with adebrelimab (an immunotherapy), plus possible chemotherapy or bevacizumab
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced lung cancer that has stopped responding to other therapies.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug combo may not work or could cause serious side effects. It is not yet proven to be safe or effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 248 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. The age of signing the informed consent is 18 -70 years, regardless of gender. 3. Provide archived or fresh tumor tissue for vendor test. 4. At least one measurable lesion according to RECIST v1.1 criteria. 5. 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. 6. The ECOG score is 0 or 1. 7. Expected survival ≥12 weeks. 8. Good level of organ function. 9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods. Exclusion Criteria: 1. Active or symptomatic brain metastases. 2. 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. 3. Uncontrollable moderate to large amounts of pleural effusion, peritoneal effusion or pericardial effusion. 4. Patients with uncontrolled tumor-related pain . 5. Have antitumor therapy was received 4 weeks before the start of the study. 6. 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. 7. 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. 8. 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. 9. Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria 10. Systemic immunosuppressive therapy was administered within 14 days prior to the first study. 11. Subjects with a prior history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, and currently known or suspected interstitial pneumonia/non-infectious pneumonia. 12. The presence of any active, known or suspected autoimmune disease. 13. Subjects with severe cardiovascular and cerebrovascular diseases. 14. Subjects who had a severe infection within 28 days prior to the first dose 15. Active hepatitis B or active hepatitis C. 16. Patients with active pulmonary tuberculosis within 1 year prior to enrolment. 17. Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication 18. History of immune deficiency 19. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment; 20. Female subjects who are pregnant or plan to become pregnant during the study period. 21. 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. 22. 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. 23. Having a bleeding tendency, a high risk of bleeding, coagulation dysfunction or thrombosis tendency (for patients using bevacizumab). 24. 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). 25. Within 6 months prior to the first administration of the medication, had a major vascular disease (for patients using bevacizumab). 26. 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. 27. 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). 28. Having severe, non-healed wounds, active ulcers or untreated fractures (for patients using bevacizumab). 29. 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). 30. CT/MRI indicated that the tumor surrounded or invaded major blood vessels (for patients who received bevacizumab treatment). 31. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese People's Liberation Army General Hospital
RECRUITINGBeijing, Beijing Municipality, China
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