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NSCLCPhase 2NCT06684873

A Multicenter, Single-arm, Open-label Study Evaluating the Safety and Efficacy of AK112 Combined With Chemotherapy as First-line Treatment for Non-squamous NSCLC Patients With BRAIN Metastases and Negative Driver Genes (IVO BRAIN)

A Phase 2 study testing AK112 Injection in people with NSCLC and Brain Metastasases, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

A multicenter, single-arm, open-label study evaluating the safety and efficacy of AK112 combined with chemotherapy as first-line treatment for non-squamous NSCLC patients with BRAIN metastases and negative driver genes Read more about this study

Who is it for?
Any age
Conditions the study is for
NSCLC, Brain Metastasases
What is being tested?
AK112 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteChina
Study dates
2 Nov 2024to 1 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The subjects voluntarily participated in the clinical study and had not received any systemic anti-tumor treatment (including any chemotherapy, targeted therapy, immunotherapy, etc.)
  • Male or female subjects aged 18-75 years (including the cutoff) at the time of signing the ICF
  • patients with histopathologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer (nsqNSCLC) with brain metastases
  • Patients were required to provide a genetic testing report that showed negative driver genes, i.e., no EFGR sensitive gene mutation, no ALK or ROS1 gene fusion, no BRAF V600E sensitive gene mutation, and no RET gene fusion
  • 5. If not, qualified tumor tissue or blood should be provided for genetic testing. 5) MRI confirmed brain parenchymal metastasis, with ≥3 brain lesions
  • 6: Or patients with 1-2 brain lesions who are not suitable for local treatment or refuse local treatment. At least one measurable brain lesion had to be at least 5mm in diameter. 6) For asymptomatic brain metastases or those with controlled intracranial hypertension after treatment with dehydration, medication could be continued at enrollment or during the study to maintain symptom stability
Show all 36Show fewer
  • 7) At least one measurable target lesion as assessed by investigator according to RECIST v1.1 within 4 weeks before the first dose
  • 8) ECOG PS score of 0-1
  • 9) predicted survival time ≥12 weeks
  • 10) good vital organ function
  • 11) Female subjects must have a negative serum pregnancy test within 3 days before treatment, agree to use effective contraception during and after treatment for 6 months, and refrain from breastfeeding during treatment
  • 12: Male patients provided consent to use contraception during treatment.
  • Exclusion Criteria:1) known history of severe allergy to any monoclonal antibody (NCI-CTCAE 5.0 > 3) Or known hypersensitivity to carboplatin/pemetrexed components
  • 2: any active infection requiring systemic anti-infective therapy within 14 days before the first dose
  • 3) myocardial infarction with uncontrolled arrhythmia (including QTc interval ≥450 ms in men and ≥470 ms in women) within 6 months before the first dose (QTc interval was calculated with Fridericia's formula)
  • 4: Or grade III-IV cardiac dysfunction according to the New York Heart Association (NYHA) standard or left ventricular ejection fraction <50% by echocardiography
  • 5) subjects with ≥ grade 2 CTCAE peripheral neuropathy
  • 6) subjects had uncontrolled or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium >ULN)
  • 7) subjects with previous or screening history of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired pulmonary function, which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity according to the investigator's judgment
  • 8) untreated active hepatitis B subjects (HBsag-positive and HBV-DNA > 1000 copies /mL (200 IU/mL) or higher than the lower limit of detection, whichever is higher) and, for those with hepatitis B, required to receive anti-HBV treatment for the duration of the study treatment
  • 9: Active hepatitis C subjects (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection)
  • 10: Or patients with known active syphilis infection (excluding patients with positive heterologous antibody test, negative non-heterologous antibody test and inactive infection confirmed by clinical judgment)
  • 11 Or a known history of human immunodeficiency virus (HIV) positivity or screening positive for HIV
  • 12) the subject has a known active or suspected autoimmune disease. Subjects who were in a stable state and did not require systemic immunosuppressive therapy were allowed to enroll.
  • 13) patients with other active malignant tumors within 5 years or at the same time. Localized tumors that had been cured for more than 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, were eligible for inclusion.
  • 14) Recipients of a live or attenuated vaccine within 28 days before the first dose, or having a plan to receive such vaccine during the study period. However, inactivated virus vaccines for seasonal influenza are permitted
  • 15) radical radiotherapy or whole brain radiotherapy (WBRT) to the skull within 3 months before the first dose
  • 16) subjects with spinal cord compression that could not be cured by surgery and/or radiotherapy
  • 17) patients with deep vein thrombosis, current anticoagulant or platelet therapy, or previous use of antiangiogenic drugs for deep vein thrombosis or severe bleeding
  • 18) poorly controlled (poorly controlled defined as BP ≥160/100 MMHG despite optimal hypertension treatment)
  • 19) had undergone major surgery within 28 days before the first dose (major surgery was defined for this study as a procedure requiring at least 3 weeks of recovery before being able to undergo study treatment)
  • 20) who are participating in another clinical study, or who have participated in any other clinical trial (including drugs, devices, etc.) and received intervention within 3 months before screening or within 5 half-lives (whichever is longer)
  • 21) candidates for or prior recipients of organ or bone marrow transplantation
  • 22) subjects had a known history of psychotropic drug abuse or drug use
  • 23) subjects with any factors considered by the investigator to be ineligible for the trial.
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

likun Chen contact

+86 13798019964

chenlk@sysucc.org.cn

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangzhou, 510000

    likun Chen, 19868589145, chenlk@sysucc.org.cn

Other trials in China

About this study

A multicenter, single-arm, open-label study evaluating the safety and efficacy of AK112 combined with chemotherapy as first-line treatment for non-squamous NSCLC patients with BRAIN metastases and negative driver genes

Read the detailed description

This is a multicenter, single-arm, open-label study. We planned to enroll 55 patients with histopathologically or cytologically confirmed stage IV nsqNSCLC with brain metastases and negative driver gene reports within three months. The aim of this study is to evaluate the safety, tolerability and efficacy of ivoricizumab combined with chemotherapy as the first-line treatment for patients with brain metastases from NSQ non-small cell lung cancer (NSCLC) without driver genes.

Eligible subjects were selected and entered the study in sequence. The trial was divided into combination chemotherapy period (C1-C4/C6) and maintenance treatment period (C5/C7-C32). During the combined chemotherapy period, all subjects were treated with everciximab injection and chemotherapy drugs after entering the study, and during the maintenance treatment period, they were treated with everciximab injection and pemetrexed. Every 3 weeks (Q3W) was a treatment cycle. The efficacy was evaluated every 2 cycles in the combined chemotherapy period and every 3 cycles in the maintenance treatment period. All the participants received treatment until they withdrew consent, had disease progression, had unacceptable toxicity, had to discontinue the drug as judged by the investigator, were lost to follow-up, died, or had received ivorximab for 2 years, whichever occurred first. After the end of treatment, the patients were followed up until death.

If there are abnormal items, for the safety of subjects, researchers can judge whether to add unplanned follow-up according to the actual situation.

Being tested
AK112 Injection

What participants receive

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

  • AK112 InjectionDrug

    AK112 injection plus chemotherapy was administered to all eligible patients

Study groups in NCT06684873
Study groupRoleWhat they receive
AK112 combined with chemotherapyExperimentalAK112 combined with chemotherapy
Receives: Drug: AK112 Injection

What is being measured

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

  1. iPFS

    iPFS was defined as the time from the date of initiation of firstline setting to the date of intracranial progression or death and was censored at the date of the last tumor assessment (when carried out)

    Measured: iPFS was defined as the time from the date of initiation of firstline setting to the date of intracranial progression or death and was censored at the date of the last tumor assessment (when carried out)

Timeline

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

  1. First posted12 Nov 2024
  2. Study start2 Nov 2024 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (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
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684873
Sponsor's protocol ID
AK112-IIT-C-M-0005
Status last verified
Nov 2024
First submitted
10 Nov 2024
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hou X, Li M, Wu G, Feng W, Su J, Jiang H, Jiang G, Chen J, Zhang B, You Z, Liu Q, Chen L. Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non-Small Cell Lung Cancer in Patients With Brain Metastases: The GAP BRAIN Open-Label, Randomized, Multicenter, Phase 3 Study. JAMA Netw Open. 2023 Feb 1;6(2):e2255050. doi: 10.1001/jamanetworkopen.2022.55050.

    PubMed 36753281

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK112 Injection in people with NSCLC and Brain Metastasases, 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 36 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: opening soon, as of the sponsor's last update on 12 Nov 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact likun Chen (+86 13798019964, chenlk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

iPFS (time frame: iPFS was defined as the time from the date of initiation of firstline setting to the date of intracranial progression or death and was censored at the date of the last tumor assessment (when carried out)). 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 NCT06684873, 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 12 Nov 2024.

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