Advanced Non-small Cell Lung CancerPhase 2/3NCT05001724
KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent
A Phase 2/3 study testing KN046, Lenvatinib and Docetaxel in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is a phase 2/3, multicenter, randomized, open, positive-controlled study of patients with advanced non-small cell lung cancer whose disease has progressed after prior anti-PD-(L)1 therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- KN046, Lenvatinib and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2021to 7 Apr 2023
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a histologically confirmed or cytologically confirmed diagnosis of advanced NSCLC;
- Non-squamous non-small cell lung cancer, no EGFR mutation or ALK rearrangement or ROS1 fusion, no known RET fusion or MET14 exon jump mutation; Squamous non-small cell lung cancer with no known EGFR mutation or ALK rearrangement or ROS1 fusion /RET fusion /MET14 exon jump mutation;
- Has received prior systemic treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy for their advanced NSCLC;
- Has measurable disease;
- 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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- Has a life expectancy of at least 3 months;
- If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
- If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.
Who cannot join
- Untreated active central nervous system metastasis or leptomeningeal metastasis;
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment;
- Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
- Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines;
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- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
- History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent;
- Previous malignant disease;
- History of uncontrolled intercurrent illness;
- Prior therapy with any antibody/drug targeting T cell coregulatory proteins;
- Has received treatment with lenvatinib or docetaxel or VEGFR-TKI;
- Known severe hypersensitivity reactions to antibody drug;
- Is pregnant or breastfeeding;
- Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Compare Efficacy, Safety, and Tolerability of KN046 Combined With Lenvatinib Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer After Failure of Anti-PD-(L)1 Agent
This is a phase 2/3, multicenter, randomized, open, positive-controlled study of patients with advanced non-small cell lung cancer whose disease has progressed after prior anti-PD-(L)1 therapy. Subjects should have documented progressive disease during prior treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy.Subjects will be randomized to two treatment groups in a 1:1 ratio.
Treatment Group: KN046 5mg/kg Q3W + lenvatinib recommended for phase III dose (RP3D) every day.
Control group: Docetaxel 75mg/m2 Q3W .
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- KN046, Lenvatinib, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN046Biological
KN046 is 5 milligram per kilogram, every 3 weeks.
LenvatinibDrug
Lenvatinib is RP3D milligram per day, every day.
DocetaxelDrug
Docetaxel is 75 milligram per Square meter, every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: KN046 plus Lenvatinib RP3D. | Experimental | Experimental arm: Cohort 1: KN046 5mg/kg every 3 weeks + lenvatinib RP3D every day until progressive disease or unacceptable toxicity. Receives: Biological: KN046; Drug: Lenvatinib |
| Docetaxel | Active comparator | Active Comparator: docetaxel 75 mg/m² every 3 weeks until progressive disease or unacceptable toxicity. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose limit toxicity (phase 2)
Measured: 28 days or 21 days
OS
Overall survival (OS) was defined as the time from randomization to death due to any cause (phase 3).
Measured: up to 2 years
PFS
Progression-free survival (PFS) was defined as the time from randomization grouping to the first documented disease progression or death from any cause as evaluated by the investigator according to RECIST 1.1 criteria (phase 3).
Measured: up to 2 years
Secondary outcomes (5)
ORR
Objective response rate (ORR) based on the RECIST 1.1 by principal investigator
Measured: up to 2 years
DCR
Disease control rate (DCR) based on the RECIST 1.1 by principal investigator
Measured: up to 2 years
DOR
Duration of response (DOR) based on the RECIST 1.1 by principal investigator
Measured: up to 2 years
CBR
Clinical benefit rate (CBR) based on the RECIST 1.1 by independent review committee
Measured: up to 2 years
TTR
Time to response (TTR) based on the RECIST 1.1 by independent review committee
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start28 Oct 2021
- Primary completion13 Feb 2023
- Study completion7 Apr 2023
Why it stopped: Because the efficacy data did not meet expectations, the sponsor decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Alphamab Biopharmaceuticals Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, MD,PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001724
- Sponsor's protocol ID
- KN046-302
- Status last verified
- Apr 2023
- First submitted
- 16 Jul 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Compare Efficacy, Safety, and Tolerability of KN046 Combined With Lenvatinib Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer After Failure of Anti-PD-(L)1 Agent
- ClinicalTrials.gov ID
- NCT05001724
- Acronym / sponsor ID
- KN046-302
- Conditions
- Advanced Non-small Cell Lung Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the efficacy data did not meet expectations, the sponsor decided to terminate the study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2/3, multicenter, randomized, open, positive-controlled study of patients with advanced non-small cell lung cancer whose disease has progressed after prior anti-PD-(L)1 therapy. Subjects should have documented progressive disease during prior treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy.Subjects will be randomized to two treatment groups in a 1:1 ratio.
Treatment Group: KN046 5mg/kg Q3W + lenvatinib recommended for phase III dose (RP3D) every day.
Control group: Docetaxel 75mg/m2 Q3W .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: KN046 plus Lenvatinib RP3D. | Experimental | Biological: KN046, Drug: LenvatinibExperimental arm: Cohort 1: KN046 5mg/kg every 3 weeks + lenvatinib RP3D every day until progressive disease or unacceptable toxicity. |
| Docetaxel | Active comparator | Drug: DocetaxelActive Comparator: docetaxel 75 mg/m² every 3 weeks until progressive disease or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has a histologically confirmed or cytologically confirmed diagnosis of advanced NSCLC;
- Non-squamous non-small cell lung cancer, no EGFR mutation or ALK rearrangement or ROS1 fusion, no known RET fusion or MET14 exon jump mutation; Squamous non-small cell lung cancer with no known EGFR mutation or ALK rearrangement or ROS1 fusion /RET fusion /MET14 exon jump mutation;
- Has received prior systemic treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy for their advanced NSCLC;
- Has measurable disease;
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
Key exclusion criteria (15 listed)
- Untreated active central nervous system metastasis or leptomeningeal metastasis;
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment;
- Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KN046KN046 is 5 milligram per kilogram, every 3 weeks. | Biological | Cohort 1: KN046 plus Lenvatinib RP3D. |
| LenvatinibLenvatinib is RP3D milligram per day, every day. | Drug | Cohort 1: KN046 plus Lenvatinib RP3D. |
| DocetaxelDocetaxel is 75 milligram per Square meter, every 3 weeks. | Drug | Docetaxel |
Primary outcome
DLT
Time frame: 28 days or 21 days
Dose limit toxicity (phase 2)
OS
Time frame: up to 2 years
Overall survival (OS) was defined as the time from randomization to death due to any cause (phase 3).
PFS
Time frame: up to 2 years
Progression-free survival (PFS) was defined as the time from randomization grouping to the first documented disease progression or death from any cause as evaluated by the investigator according to RECIST 1.1 criteria (phase 3).
5 secondary outcomes
ORR
Time frame: up to 2 years
DCR
Time frame: up to 2 years
DOR
Time frame: up to 2 years
CBR
Time frame: up to 2 years
TTR
Time frame: up to 2 years
Results and safety
The study was stopped early (reason given: Because the efficacy data did not meet expectations, the sponsor decided to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caicun Zhou, MD,PhD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing KN046, Lenvatinib and Docetaxel in people with Advanced 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 15 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 25 Apr 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 combined 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.
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 was stopped early (reason given: Because the efficacy data did not meet expectations, the sponsor decided to terminate the 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?
DLT (time frame: 28 days or 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2023.