AzTrials
AzTrials

Stage IV Non-small Cell Lung CancerPhase 2NCT03838848

KN046 in Patients With Advanced Non-small Cell Lung Cancer

A Phase 2 study testing KN046, Carboplatin and Pemetrexed in people with Stage IV Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a phase II, open label, multicenter study in subjects with advanced non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stage IV Non-small Cell Lung Cancer
What is being tested?
KN046, Carboplatin and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
5 May 2019to 30 Jul 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

  • Signed inform consent form(ICF);
  • Age ≥ 18 years and ≤ 75 years, male or female;
  • Histologically or cytologically documented NSCLC,Stage IV (AJCC Version 8) .
  • At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1;
  • Biopsy specimens obtained from nonradiated areas within 1 year, formalin-fixed, paraffin-embedded blocks containing tumor tissues suitable for biomarker determination, or 15-20 slides (more slides are encouraged to be provided with a minimum of 8 slides; if less than 8 slides are provided, the subject may also be enrolled after consultation and agreement between the Sponsor and the investigator); and fresh biopsy samples collected within 42 days prior to the first dose are required for determination in Cohorts C, D, and E;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Show all 9Show fewer
  • Life expectancy > 12 weeks;
  • Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
  • Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

Who cannot join

  • Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated.
  • Having participated in any interventional clinical study within 28 days prior to drug administration in this study.
  • Having received other anti-tumor therapy within 28 days before administration in this study, including traditional Chinese medicine with anti-tumor indications;
  • Having received major surgical treatment (such as major abdominal, transthoracic surgery; excluding diagnostic aspiration or peripheral vascular access replacement) within 28 days prior to drug administration in this study;
  • Having received radical radiotherapy within 3 months prior to drug administration in this study; palliative radiation therapy within 2 weeks prior to the first dose is allowed, the radiation dose meets the diagnostic and treatment criteria for local palliative treatment, and the radiation coverage is less than 30% of the bone marrow area;
  • Subjects who require systemic corticosteroids (≥ 10 mg/day prednisone or equivalent dose of other corticosteroids) or immunosuppressive therapy within 14 days prior to drug administration in this study; except for inhaled or topical corticosteroids, or physiologic replacement doses of corticosteroids for adrenal insufficiency; short-term (≤ 7 days) corticosteroids are allowed for prophylaxis (e.g., contrast media allergy) or for the treatment of non-autoimmune disorders (e.g., delayed type hypersensitivity due to contact allergens);
Show all 16Show fewer
  • Having received live vaccines (including live attenuated vaccines) within 28 days prior to drug administration in this study;
  • Previous or current interstitial pneumonia/pneumopathy; Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
  • Subjects who have prior or current autoimmune diseases;
  • Subjects who have other malignancies within 5 years before the first dose;
  • Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection, Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
  • Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia;
  • History of allogeneic bone marrow or organ transplantation;
  • Prior history of allergic reaction, hypersensitivity reaction, and intolerance to antibody drugs; history of significant allergy to drugs;
  • Pregnant and/or lactating women;
  • Other conditions that, in the opinion of the investigator, will affect the safety or compliance of the subjects with the study treatment, including but not limited to psychiatric disorders, uncontrolled moderate to severe serous cavity effusions with large amounts of serous cavity effusions or requiring repeated drainage.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai

Other trials in China

About this study

Official title: A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of KN046 in Patients With Advanced Non-small Cell Lung Cancer

This is a phase II, open label, multicenter study in subjects with advanced non-small cell lung cancer.

Read the detailed description

A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of KN046 in Subjects with Advanced Non-small Cell Lung Cancer

Being tested
KN046, Carboplatin, Pemetrexed, Ningetinib
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.

  • KN046Drug

    Also called Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection

    3mg/kg, Q2W, intravenous injection (IV)

  • KN046Drug

    Also called Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection

    5mg/kg, Q2W, intravenous injection (IV)

  • KN046Drug

    Also called Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection

    5mg/kg, Q3W, intravenous injection (IV)

  • CarboplatinDrug

    AUC 5 IV Q3W; total dose calculated according to the Calvert formula, with the highest dose not exceeding 750 mg; 4 cycles.

  • PemetrexedDrug

    500 mg/m2, Q3W, intravenous injection (IV)

  • NingetinibDrug

    Oral, QD

Study groups in NCT03838848
Study groupRoleWhat they receive
Cohort AExperimentalSubjects with Non-small Cell Lung Cancer (NSCLC) (failed or did not tolerant to platinum-containing regime and did not treat with programmed cell death protein 1/the programmed death-ligand 1 (PD1/PDL-1) checkpoint inhibitor previously) will receive KN046 3 milligram per kilogram (mg/kg), every other weeks (Q2W)
Receives: Drug: KN046
Cohort BExperimentalSubjects with NSCLC (failed or did not tolerant to platinum-containing regime and did not treat with PD1/PDL-1 checkpoint inhibitor previously) will receive KN046 5 mg/kg, Q2W
Receives: Drug: KN046
Cohort CExperimentalSubjects with NSCLC (failed or did not tolerant to platinum-containing regime and failed to PD1/PDL-1 checkpoint inhibitor) will receive KN046
Receives: Drug: KN046
Cohort DExperimental1L NSCLC (EGFR-sensitive mutation (Ex19del or L858R), progression after at least one line treatemtn of EGFR TKIs, and no prior systemic platinum-containing chemotherapy), will receive KN046 5 mg/kg Q3W in combination with pemetrexed and carboplatin
Receives: Drug: KN046; Drug: Carboplatin; Drug: Pemetrexed
Cohort EExperimental≥ 2L NSCLC (failure or intolerance of 1L platinum-doublet chemotherapy; and failure of PD-1/PD-L1 checkpoint inhibitor therapy), will receive KN046 in combination with ningetinib
Receives: Drug: KN046; Drug: Ningetinib

What is being measured

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

  1. ORR

    clinical response rate (ORR) as determined by the independent review board (IRC) based on RECIST 1.1 criteria

    Measured: 2 years

  2. DOR

    clinical response time (DOR) as determined by the independent review board (IRC) based on RECIST 1.1 criteria

    Measured: 2 years

Timeline

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

  1. First posted12 Feb 2019
  2. Study start5 May 2019
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Why it stopped: Cohort A,B,C end enrollments. Cohort D and E were considered to have no significant clinical benefit at the SMC meeting and decided to terminate enrollment.

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
Non-randomised
Intervention model
Sequential
Model description
Cohort A, B and C are carried out in sequence, a Scientific Monitoring Committee (SMC) will decide whether to enter the next group (A to B, B to C). Cohort D: 1L NSCLC (EGFR-sensitive mutation (Ex19del or L858R), progression after at least one line treatemtn of EGFR TKIs, and no prior systemic platinum-containing chemotherapy); Cohort E: ≥ 2L NSCLC (failure or intolerance of 1L platinum-doublet chemotherapy; and failure of PD-1/PD-L1 checkpoint inhibitor therapy);
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03838848
Sponsor's protocol ID
KN046-201
Status last verified
Feb 2023
First submitted
1 Feb 2019
Last updated
2 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xiong A, Li W, Li X, Fan Y, Ma Z, Fang J, Xie Q, Zhuang W, Kang M, Wang J, Xu T, Xu M, Zhi L, Liu Q, Wang N, Zhou C. Efficacy and safety of KN046, a novel bispecific antibody against PD-L1 and CTLA-4, in patients with non-small cell lung cancer who failed platinum-based chemotherapy: a phase II study. Eur J Cancer. 2023 Sep;190:112936. doi: 10.1016/j.ejca.2023.05.024. Epub 2023 Jun 5.

    PubMed 37393762

  • Song X, Xiong A, Wu F, Li X, Wang J, Jiang T, Chen P, Zhang X, Zhao Z, Liu H, Cheng L, Zhao C, Wang Z, Pan C, Cui X, Xu T, Luo H, Zhou C. Spatial multi-omics revealed the impact of tumor ecosystem heterogeneity on immunotherapy efficacy in patients with advanced non-small cell lung cancer treated with bispecific antibody. J Immunother Cancer. 2023 Feb;11(2):e006234. doi: 10.1136/jitc-2022-006234.

    PubMed 36854570

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KN046, Carboplatin and Pemetrexed in people with Stage IV Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd 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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 2 Mar 2023. 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?

The study was stopped early (reason given: Cohort A,B,C end enrollments. Cohort D and E were considered to have no significant clinical benefit at the SMC meeting and decided to terminate enrollment.). 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?

ORR (time frame: 2 years). 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 NCT03838848, 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 2 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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