New combo therapy shows promise for lung cancer brain metastases
NCT ID NCT04768075
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether adding the immunotherapy drug camrelizumab to standard chemotherapy and radiation helps people with advanced lung cancer whose disease has spread to the brain. The trial included 60 patients who had not received chemotherapy before. Researchers measured how long it took for brain tumors to grow or for patients to die, comparing the camrelizumab combination to a placebo combination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Camrelizumab (an immunotherapy drug) combined with chemotherapy (cisplatin/carboplatin plus pemetrexed, paclitaxel, or nab-paclitaxel) and possibly radiation therapy (SRT or WBRT)
- What this could lead to
- If successful, this combination could offer a new treatment option that delays brain tumor growth and improves survival for people with advanced lung cancer that has spread to the brain.
- What could go wrong
- This is a completed Phase 3 trial with only 60 participants, so results may not apply to all patients. Immunotherapy can cause immune-related side effects, and the addition of radiation may increase toxicity.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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60 people
The number who actually took part.
- Started
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May 2021
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 75 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. Histological or cytological diagnosis of non-small cell lung cancer(NSCLC); 2. MRI confirmed brain parenchyma metastasis, ≥ 3 brain lesions, or 1-2 brain lesions but not suitable for local treatment or refused local treatment. At least one brain measurable lesion ≥ 5mm . Included with or without neurological symptoms; 3. Has not received prior systemic treatment for metastatic NSCLC. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent must have experienced interval of at least 12 months from diagnosed of advanced or metastatic disease since the end of surgery; 4. Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated; 5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status; 6. Has adequate organ function; 7. Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results. Subjects willing to use an effective contraceptive method during the study and within 90 days after the last dose of study medication; 8. Subjects should be able to follow the research and follow-up procedures; 9. Subjects should be voluntarily participating in clinical studies and informed consent should be signed; Exclusion Criteria: 1. Brain metastases with hemorrhage; 2. Meningeal involvement with metastatic carcinoma; 3. Subjects with ROS1 mutation, RET fusion positive, BRAF V600E mutation, NTRK fusion positive; 4. Participated in other clinical trials, or finish other clinical trials within 4 weeks; 5. Subject was received irradiation of brain; 6. Subjects have received solid organ or blood system transplantation; 7. Active autoimmune diseases requiring systemic treatment (such as the use of disease remission drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy; 8. Subjects diagnosed immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy of non-related tumor within 7 days before the first dose; allowed physiological dose of glucocorticoid (≤10 mg/day Prednisone or equivalent); 9. Within 1 year before the first dose, there was a history of non-infectious pneumonia or interstitial lung disease requiring glucocorticoid treatment; 10. Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval \> 450 ms for males and QTc interval \> 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% according to NYHA criteria; 11. Has known history of Human Immunodeficiency Virus (HIV); 12. Untreated active hepatitis B; 13. Subjects have active hepatitis B; 14. Subjects have severe infections within 4 weeks of the first dose of study treatment; 15. Subjects with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month; 16. Women who are pregnant or lactating; 17. Has known allergy to Camrelizumab, or pemetrexed, or paclitaxel, or albumin paclitaxel, or carboplatin, or cisplatin or any of accessories; 18. A prior malignancy other than NSCLC within 5 years before randomization,except carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of skin cancer with adequately treated, localized prostate cancer or ductal carcinoma in situ after radical resection.
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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.
Contacts and locations
Locations
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Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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Affiliated Hospital of Hebei University / School of Clinical Medicine
Baoding, Hebei, China
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Affiliated Tumor Hospital of Guangxi Medical University
Nanning, China
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
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Binzhou Medical University Hospital
Binzhou, Shandong, China
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Fujian Cancer Hospital
Fujian, Fuzhou, China
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Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
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The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
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Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
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Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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- Can a new drug shrink advanced solid tumors?
- Can a less extensive lung cancer surgery be just as effective?