AzTrials
AzTrials

Non-squamous Non-small-cell Lung CancerPhase 2CAP-BRAINNCT04211090

Camrelizumab With AC in Patients With Brain Metastases of Driven Gene-negative,NSCLC

A Phase 2 study testing Camrelizumab, Pemetrexed and Carboplatin in people with Non-squamous Non-small-cell Lung Cancer and Brain Metastases, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The primary hypothesis is that camrelizumab in combination with pemetrexed/ carboplatin will present a better efficacy for treatment of first line metastatic non-squamous non-small cell lung cancer and minimize the risk of toxicity Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Camrelizumab, Pemetrexed and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
15 Jan 2020to 30 Dec 2022
Phase
Phase 2
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-squamous non-small cell lung cancer（NSCLC）
  • Patients with asymptomatic BM or intracranial hypertension symptoms can be controlled after dehydration therapy, who can continue medication to maintain stable symptoms at enrollment or during the study;
  • Patients with MRI confirmed parenchymal brain metastases with ≥ 3 brain lesions; or patients with 1-2 brain lesions who are not suitable for or refuse local therapy. At least one measurable lesion must be ≥ 5 mm in diameter in brain lesions; patients with local meningeal metastases are allowed to be included, but those with extensive meningeal metastases are not included;
  • No prior systemic therapy for metastatic NSCLC; chemotherapy and/or radiotherapy as part of neoadjuvant/adjuvant therapy are allowed, but the time interval from the end of surgery to diagnosis of advanced or metastatic disease should be no less than 6 months;
  • Study sites must be able to provide relevant documentation of EGFR mutation and ALK fusion status of subjects which must be negative. If tumor tissue samples at or after the diagnosis of advanced tumors are available, archived within 1 year prior to the first dose or freshly obtained, testing for PD-L1 levels can be performed prior to enrollment or during the study;
  • Age ≥ 18 years;
Show all 32Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Life expectancy of more than 3 months;
  • Adequate hematopoietic function, defined as absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109 /L, hemoglobin ≥ 90 g/L [no blood transfusion within 7 days or no erythropoietin (EPO) dependence];
  • Adequate liver function, defined as total bilirubin level ≤ 1.5 times the upper limit of normal (ULN); for patients without liver metastases, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; for patients with documented liver metastases, AST and ALT levels ≤ 5 times ULN;
  • Adequate renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); urine protein in urine routines less than 2+, if the patient has a urine protein ≥ 2+ at baseline, 24-hour urine should be collected and tested to ensure 24-hour urine protein quantification ≤ 1 g;
  • Adequate coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; anticoagulant therapy is allowed, as long as the PT is within the intended range of the anticoagulant drugs;
  • Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug (Cycle 1, Day 1). If a urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required; women and men of childbearing potential must agree to use appropriate methods of contraception or have been surgically sterilized during the study and within 90 days after the last dose of the study drugs;
  • Able to comply with the study and follow-up procedures;
  • Sign the written informed consent prior to the implementation of any study-related procedures.
  • Exclusion Criteria Subjects who meet any of the following criteria are not eligible for inclusion in this study:
  • Mixed non-small cell and small cell carcinoma, or adenosquamous cell lung cancer with an adenocarcinoma component < 50% (if the adenocarcinoma component is ≥ 50%, the inclusion criteria are met);
  • Currently participating in an interventional clinical trial, or receiving other study drugs or treatment with study devices within 4 weeks prior to the first dose;
  • Patients who have received prior systemic anti-tumor therapy;
  • Patients who have received solid organ or blood system transplantation;
  • Active autoimmune disease requiring systemic therapy (e.g., use of disease modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Substitution therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy;
  • Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; physiologic doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent drugs) are allowed;
  • History of noninfectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose or current interstitial lung disease;
  • Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
  • Untreated active hepatitis B; Note: subjects with hepatitis B who meet the following criteria are also eligible for inclusion:
  • HBV viral load must be < 500 IU/ml prior to the first dose, and anti-HBV therapy should be administered at the discretion of the investigator throughout the study to avoid viral reactivation;
  • For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored;
  • Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
  • Pregnant and lactating women;
  • Known allergy to Camrelizumab, Pemetrexed, Carboplatin, or any of their excipients;
  • Malignancies other than NSCLC within 5 years prior to enrollment, except adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin carcinoma, localized prostatic carcinoma after radical surgery, and ductal carcinoma in situ after radical surgery.
  • Subjects with active pulmonary tuberculosis (TB) are excluded. Suspected active TB need to be excluded by chest x-ray, sputum examination and clinical symptoms and signs.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Li-Kun Chen

    Guangzhou, Guangzhou, 510006

Other trials in China

About this study

Official title: A Phase II Study to Evaluate Camrelizumab With Pemetrexed / Carboplatin in Patients With Brain Metastases of Driven Gene-negative, Non-squamous Non-small Cell Lung Cancer

The primary hypothesis is that camrelizumab in combination with pemetrexed/ carboplatin will present a better efficacy for treatment of first line metastatic non-squamous non-small cell lung cancer and minimize the risk of toxicity

Read the detailed description

This is a prospective, open-label, phase Ⅱ studyto evaluate the efficacy and safetyof camrelizumab combined with pemetrexed/ carboplatin in participants with brain metastases ofnon-squamous non-small cell lung cancer.Paticipant was confirmed without EGFR activating mutation or ALK fusion, and received no prior systemic therapy.Patients would receive camrelizumab in combination with pemetrexed/ carboplatin for 4 cycles，followed by camrelizumab and pemetrexed as maitenance treatment until progression, camrelizumab will be administered no more than 24 months. PD-L1 expression assessed with 22C3 pharmDx assay will be used as a stratification factor.

Keywords
Non-squamous Non-small-cell Lung Cancer, Brain Metastases
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens

  • PemetrexedDrug

    Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens

  • CarboplatinDrug

    Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens

Study groups in NCT04211090
Study groupRoleWhat they receive
Camrelizumab with pemetrexed / carboplatinExperimentalCamrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer
Receives: Drug: Camrelizumab; Drug: Pemetrexed; Drug: Carboplatin

What is being measured

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

  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) of intracranial lesion according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: 1 year

Secondary outcomes (4)

  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 intracranial lesions according to modified RECIST 1.1 or death from any cause

    Measured: 3.5year

  2. Objective Response Rate (ORR)

    ORR 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) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: 3.5year

  3. Progression-free Survival (PFS)

    Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of overall disease or death from any cause

    Measured: 3.5year

  4. Incidence of Adverse Events (AEs)

    Incidence of Adverse Events (AEs) in the treatment of Camrelizumab combined with pemetrexed / carboplatin for patients with brain metastasis according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03

    Measured: 3.5year

Timeline

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

  1. First posted26 Dec 2019
  2. Study start15 Jan 2020
  3. Primary completion30 Aug 2022
  4. Study completion30 Dec 2022 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211090
Sponsor's protocol ID
B2019-203-X04
Acronym
CAP-BRAIN
Status last verified
Nov 2022
First submitted
22 Dec 2019
Last updated
16 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hou X, Zhou C, Wu G, Lin W, Xie Z, Zhang H, Yi J, Lv J, Cheng F, She F, Chen L. First-line camrelizumab plus pemetrexed and carboplatin for advanced non-squamous non-small-cell lung cancer with brain metastases (CAP-BRAIN): final results of a multicentre, open-label, single-arm, phase 2 trial in China. EClinicalMedicine. 2025 Nov 12;90:103638. doi: 10.1016/j.eclinm.2025.103638. eCollection 2025 Dec.

    PubMed 41324015

  • Li M, Chen J, Yu H, Zhang B, Hou X, Jiang H, Xie D, Chen L. Cerebrospinal fluid immunological cytokines predict intracranial tumor response to immunotherapy in non-small cell lung cancer patients with brain metastases. Oncoimmunology. 2023 Dec 7;13(1):2290790. doi: 10.1080/2162402X.2023.2290790. eCollection 2024.

    PubMed 38169917

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Pemetrexed and Carboplatin in people with Non-squamous Non-small-cell Lung Cancer and Brain Metastases, run by Sun Yat-sen University 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 32 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. 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 phase mean?

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?

Results are not available in the source record.

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 Objective Response Rate (iORR) (time frame: 1 year). 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 NCT04211090, which also lists 2 linked publications.

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 16 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in