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Non-Small-Cell Lung CancerPhase 3NCT04768075

Camrelizumab Combined With SRT/WBRT and Chemotherapy in Patients With Brain Metastases of Driven Gene-negative NSCLC

A Phase 3 study testing Camrelizumab, Cisplatin and Carboplatin in people with Non-Small-Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a randomized, double-blind, placebo-controlled, multi-center clinical study. Target population is patients with stage IV non-small cell lung cancer who had not received systemic chemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
Camrelizumab, Cisplatin and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
14 sitesChina
Study dates
28 May 2021to 30 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological diagnosis of non-small cell lung cancer（NSCLC）;
  • 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;
  • 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;
  • Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated;
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
  • Has adequate organ function;
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  • 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;
  • Subjects should be able to follow the research and follow-up procedures;
  • Subjects should be voluntarily participating in clinical studies and informed consent should be signed;

Who cannot join

  • Brain metastases with hemorrhage；
  • Meningeal involvement with metastatic carcinoma;
  • Subjects with ROS1 mutation, RET fusion positive, BRAF V600E mutation, NTRK fusion positive;
  • Participated in other clinical trials, or finish other clinical trials within 4 weeks;
  • Subject was received irradiation of brain;
  • Subjects have received solid organ or blood system transplantation;
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  • 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;
  • 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);
  • Within 1 year before the first dose, there was a history of non-infectious pneumonia or interstitial lung disease requiring glucocorticoid treatment;
  • 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;
  • Has known history of Human Immunodeficiency Virus (HIV)；
  • Untreated active hepatitis B；
  • Subjects have active hepatitis B；
  • Subjects have severe infections within 4 weeks of the first dose of study treatment；
  • Subjects with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month;
  • Women who are pregnant or lactating；
  • Has known allergy to Camrelizumab, or pemetrexed, or paclitaxel, or albumin paclitaxel, or carboplatin, or cisplatin or any of accessories;
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Affiliated Hospital of Hebei University / School of Clinical Medicine

    Baoding, Hebei

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • Binzhou Medical University Hospital

    Binzhou, Shandong

  • Fujian Cancer Hospital

    Fujian, Fuzhou

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong

  • Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Affiliated Tumor Hospital of Guangxi Medical University

    Nanning

  • Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

Other trials in China

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Multi-center Study of Camrelizumab Combined With SRT/WBRT and Chemotherapy in Patients of NSCLC With Brain Metastases of Driven Gene-negative and Not Received Systemic Chemotherapy

This study is a randomized, double-blind, placebo-controlled, multi-center clinical study. Target population is patients with stage IV non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of Camrelizumab + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT with placebo + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Read the detailed description

Detailed Description:

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Paticipant was confirmed without EGFR activating mutation or ALK fusion and received no prior systemic therapy. Patients would receive Camrelizumab/placebo in combination with chemotherapy for 4-6 cycles，non-squamous subject followed by Camrelizumab/placebo + pemetrexed as maintenance treatment until progression or unacceptable toxicity, squamous subject followed by Camrelizumab/placebo as maintenance treatment until progression or unacceptable toxicity, Camrelizumab/placebo for a maximum of 2 years.

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.

  • CamrelizumabDrug

    Also called SHR-1210

    Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody

  • PlaceboDrug

    Also called Simulator of Camrelizumab

    IV infusion Simulator of Camrelizumab

  • CisplatinDrug

    Also called cisplatinum

    IV infusion

  • CarboplatinDrug

    Also called Carboplat

    IV infusion

  • PemetrexedDrug

    Also called Pemetrexed disodium

    IV infusion

  • PaclitaxelDrug

    Also called Paclitaxel injection

    IV infusion

  • Albumin paclitaxelDrug

    Also called Nab-paclitaxel

    IV infusion

Study groups in NCT04768075
Study groupRoleWhat they receive
Camrelizumab groupExperimentalsubject will receive Camrelizumab intravenously(IV) PLUS pemetrexed or paclitaxel or albumin paclitaxel PLUS cisplatin or carboplatin AUC 5 on Day 1 of each 3-week cycle(Q3W) for 4-6 cycles followed by Camrelizumab ± pemetrexed IV Q3W until progression (up to approximately 2 years). Whether the subject accepts intracranial radiotherapy will be decided by investigators according to the guidelines and the conditions of the subjects.
Receives: Drug: Camrelizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Albumin paclitaxel
placebo groupPlacebo comparatorsubject will receive placebo intravenously (IV) PLUS pemetrexed or paclitaxel or albumin paclitaxel PLUS cisplatin or carboplatin AUC 5 on Day 1 of each 3-week cycle(Q3W) for 4-6 cycles followed by placebo ± pemetrexed IV Q3W until progression (up to approximately 2 years). Whether the subject accepts intracranial radiotherapy will be decided by investigators according to the guidelines and the conditions of the subjects.
Receives: Drug: Placebo; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Albumin paclitaxel

What is being measured

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

  1. Intracranial Progression-Free Survival(iPFS)

    Intracranial Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression in brain metastasis disease or death from any cause or switch therapy

    Measured: up to 24 months

  2. Progression-Free Survival (PFS)

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

    Measured: up to 24 months

Secondary outcomes (8)

  1. Intracranial Objective Response Rate (iORR)

    iORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response(PR: ≥30% decrease in the sum of diameters of target lesions) in brain lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: up to 24 months

  2. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants in the analysis population who had a CR or a PR.

    Measured: up to 24 months

  3. Intracranial Duration of Response (iDOR)

    iDOR was defined as the time from first documented evidence of a CR or PR until PD or death

    Measured: up to 24 months

  4. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: up to death

  5. Duration of Response (DOR)

    DOR was defined as the time from first documented evidence of a CR or PR until PD or death

    Measured: up to 24 months

  6. Adverse events (AEs)/ Serious adverse event (SAE)

    All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0

    Measured: up to 24 months

  7. Mini-Mental State Examination (MMSE)

    Assessment of cognitive function using the Mini-Mental State Examination (MMSE). The MMSE evaluates orientation, registration, attention and calculation, recall, and language. Total scores range from 0 to 30, with higher scores indicating better cognitive function.

    Measured: Assessed at baseline and at each scheduled tumor imaging assessment (every 6 weeks for the first 48 weeks, then every 12 weeks thereafter) up to 24 months

  8. Hopkins Verbal Learning Test - Revised (HVLT-R)

    Assessment of verbal learning and memory using the Hopkins Verbal Learning Test - Revised (HVLT-R). The HVLT-R consists of three learning trials of a 12-word list, a delayed recall trial, and a delayed recognition trial. Total recall score (trials 1-3) ranges from 0 to 36, delayed recall score from 0 to 12, and recognition discrimination index from -12 to 12. Higher scores indicate better verbal learning and memory function.

    Measured: Assessed at baseline and at each scheduled tumor imaging assessment (every 6 weeks for the first 48 weeks, then every 12 weeks thereafter) up to 24 months

Timeline

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

  1. First posted24 Feb 2021
  2. Study start28 May 2021
  3. Primary completion1 Mar 2026
  4. Study completion30 Apr 2026

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04768075
Sponsor's protocol ID
CTONG2003
Status last verified
May 2026
First submitted
4 Feb 2021
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li YS, Yu Q, Bu Q, Lin L, Ning F, Zhao Y, Wu G, Lin G, Zang A, Sun H, Huang J, Tu HY, Ma S, Zhou C, Liu A, Wang C, Yao Y, Han G, Zhao J, Zhou Q, Yan HH, Liu SM, Zheng MM, Lv J, Cheng F, Chen Z, Zhong WZ, Pan Y, Yang JJ, Wu YL. First-Line Camrelizumab Versus Placebo Plus Chemotherapy With or Without Radiotherapy for Brain Metastases in NSCLC: The CTONG 2003 Randomized Placebo-Controlled Trial. J Thorac Oncol. 2025 Jul;20(7):928-940. doi: 10.1016/j.jtho.2025.02.004. Epub 2025 Feb 8.

    PubMed 39929333

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camrelizumab, Cisplatin and Carboplatin in people with Non-Small-Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 14 sites 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 18 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: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial Progression-Free Survival(iPFS) (time frame: up to 24 months). The study lists 2 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 NCT04768075, which also lists 1 linked publication.

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 20 May 2026.

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