New combo therapy shows promise for lung cancer brain metastases

NCT ID NCT04768075

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

May 2021

Finished

Apr 2026

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • Affiliated Hospital of Hebei University / School of Clinical Medicine

    Baoding, Hebei, China

  • Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, China

  • Binzhou Medical University Hospital

    Binzhou, Shandong, China

  • Fujian Cancer Hospital

    Fujian, Fuzhou, China

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, China

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