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Lung Cancer Non-Small Cell Stage IIIB/IIIC/IVPhase 1/2NCT04647344

A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 1/2 study testing AK104 plus Carboplatin and Pemetrexed and AK104 plus Carboplatin and paclitaxel in people with Lung Cancer Non-Small Cell Stage IIIB/IIIC/IV, run by Akeso at 1 site in China.

Completed

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

Official record
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Trial summary

This is a phase Ib/II , open-label, multicenter single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 combined with Carboplatin and Pemetrexed/ Paclitaxel as first-line therapy in patients with locally advanced or metastatic non-small cell lung… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
AK104 plus Carboplatin and Pemetrexed and AK104 plus Carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
24 Nov 2020to 31 Dec 2023
Phase
Phase 1/2
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 written informed consent form voluntarily.
  • Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the informed consent form.
  • Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
  • Expected life expectance ≥ 3 months.
  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.
  • No prior systemic chemotherapy for advanced or metastatic NSCLC. Subjects who have received prior adjuvant chemotherapy or neoadjuvant chemotherapy with curative intent, or definitive chemoradiotherapy for advanced disease, will be eligible provided that progression has occurred >6 months from last treatment.
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  • At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously irradiated will not be considered a target lesion.
  • Subjects must provide an available tumor tissue sample taken < 1 year prior to first dose of study treatment.
  • Subjects must provide wild-type epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) reported by tissue-based tests（for non-squamous NSCLC subjects only）.
  • Adequate organ function.
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception.
  • nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.

Who cannot join

  • Subjects who are diagnosed as NSCLC that harbors an epidermal growth factor receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation.
  • Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible
  • Received prior treatment with EGFR inhibitors or ALK inhibitors.
  • Is currently participating intervention study or has participated in a study of an investigational agent or investigational device within 4 weeks prior to administration of AK104.
  • Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as Inducible T-cell co-stimulator (ICOS) or agonists (e.g. CD40, CD137, GITR and OX40 etc).
  • Subjects who received non-thoracic radiotherapy >30 Gy within 4 weeks prior to the first dose , or thoracic radiotherapy >30 Gy within 24 weeks prior to the first dose study drug.
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  • Other active malignancies within 2 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
  • Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease,
  • Subjects who require systemic corticosteroids (a dose equivalent to >10 mg/day prednisone) or other immunosuppressive drugs within 14 days prior to administration of AK104.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Active or previously documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
  • Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
  • Known history of active tuberculosis (TB).
  • An active infection requiring systemic therapy.
  • Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 1000 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <1000 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
  • Known history of testing positive for human immunodeficiency virus (HIV).
  • Presence of meningeal metastasis, spinal cord compression, leptomeningeal disease or active brain metastasis.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
  • Receipt of live vaccination within 30 days of planned treatment start, or plan to receive live vaccine during the study.
  • Known history of server hypersensitivity to other monoclonal antibodies.
  • Known severe allergic reactions to pemetrexed, paclitaxel, carboplatin or platinum-containing component, or their preventive medications.
  • Known allergic reactions to any ingredients of AK104.
  • Known history of substance abuse, or alcohol abuse
  • Pregnant or lactating women.
  • Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of study results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Center

    Guanzhou, Guangdong

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase Ib/II Study of AK104, Combined Chemotherapy as First-line Therapy to Treat Locally Advanced or Metastatic Non-small Cell Lung Carcinoma

This is a phase Ib/II , open-label, multicenter single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 combined with Carboplatin and Pemetrexed/ Paclitaxel as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer.

Being tested
AK104 plus Carboplatin and Pemetrexed, AK104 plus Carboplatin and paclitaxel

What participants receive

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

  • AK104 plus Carboplatin and PemetrexedDrug

    Subjects receive AK104 15mg/kg intravenously (IV) plus pemetrexed 500 mg/m^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK104 15mg/kg IV plus pemetrexed 500 mg/m^2 IV Q3W until progression.

  • AK104 plus Carboplatin and paclitaxelDrug

    Subjects receive AK104 15mg/kg intravenously (IV) plus paclitaxel 175 mg/m^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK104 15mg/kg IV IV Q3W until progression.

Study groups in NCT04647344
Study groupRoleWhat they receive
Nonsquamous NSCLCExperimentalNot described
Receives: Drug: AK104 plus Carboplatin and Pemetrexed
Squamous NSCLCExperimentalNot described
Receives: Drug: AK104 plus Carboplatin and paclitaxel

What is being measured

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

  1. The number of subjects experiencing adverse events (AEs) (Phase Ib)

    Measured: From the time of informed consent through 90 days following termination of treatment with investigational product

  2. Objective response rate (ORR) assessed by investigator

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Disease control rate (DCR)

    Measured: Up to 2 years

  2. Duration of response (DoR)

    Measured: Up to 2 years

  3. Progression-free survival (PFS)

    Measured: Up to 2 years

  4. Overall survival (OS)

    Measured: Up to 2 years

  5. Time to response (TTR)

    Measured: Up to 2 years

  6. Minimum observed concentration (Cmin) of AK104 at steady state

    Measured: From first dose of AK104 through 90 days after last dose of AK104

  7. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    Measured: From first dose of AK104 through 90 days after last dose of AK104

Timeline

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

  1. First posted30 Nov 2020
  2. Study start24 Nov 2020
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04647344
Sponsor's protocol ID
AK104-207
Status last verified
Apr 2024
First submitted
21 Nov 2020
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK104 plus Carboplatin and Pemetrexed and AK104 plus Carboplatin and paclitaxel in people with Lung Cancer Non-Small Cell Stage IIIB/IIIC/IV, run by Akeso 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 12 inclusion and 26 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 25 Apr 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 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?

The number of subjects experiencing adverse events (AEs) (Phase Ib) (time frame: From the time of informed consent through 90 days following termination of treatment with investigational product). 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 NCT04647344.

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 25 Apr 2024.

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