Squamous Non-small-cell Lung CancerPhase 3NCT04474119
KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer
A Phase 3 study testing KN046 in people with Squamous Non-small-cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously received systemic treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Non-small-cell Lung Cancer
- What is being tested?
- KN046
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 482 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2020to 30 Aug 2023
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV squamous NSCLC.
- No known epidermal growth factor receptor (EGFR) mutations.
- Has measurable disease.
- Has not received prior systemic treatment for their advanced/metastatic NSCLC.
- Can provide tumor tissue.
- Has a life expectancy of at least 3 months.
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- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Has adequate organ function
- 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 CNS 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;
- Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first 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. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration 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);
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- Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
- 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
- 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 Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Platinum-containing Chemotherapy Versus Placebo Combined With Platinum-containing Chemotherapy in First Line Advanced Squamous Non-small Cell Lung Cancer Subjects (ENREACH-L-01)
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously received systemic treatment.
- Conditions
- Squamous Non-small-cell Lung Cancer
- Being tested
- KN046, KN046 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN046Drug
In combine therapy stage, KN046 is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.
KN046 placeboDrug
In combine therapy stage, KN046 placebo is 5 milligram per kilogram, every 3 weeks.
In maintain stage, KN046 placebo is 5 milligram per kilogram, every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | KN046 plus Carboplatin and Paclitaxel Receives: Drug: KN046 |
| Control arm | Placebo comparator | Placebo plus Carboplatin and Paclitaxel Receives: Drug: KN046 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Measured: up to 2 years
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up.
Measured: up to 3 years
Secondary outcomes (1)
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigators
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
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 posted16 Jul 2020
- Study start14 Sep 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 482 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
- NCT04474119
- Sponsor's protocol ID
- KN046-301
- Status last verified
- Nov 2021
- First submitted
- 13 Jul 2020
- Last updated
- 24 Nov 2021
- Results posted
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Platinum-containing Chemotherapy Versus Placebo Combined With Platinum-containing Chemotherapy in First Line Advanced Squamous Non-small Cell Lung Cancer Subjects (ENREACH-L-01)
- ClinicalTrials.gov ID
- NCT04474119
- Acronym / sponsor ID
- KN046-301
- Conditions
- Squamous Non-small-cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 16 Jul 2020 (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 study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously received systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: KN046KN046 plus Carboplatin and Paclitaxel |
| Control arm | Placebo comparator | Drug: KN046 placeboPlacebo plus Carboplatin and Paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV squamous NSCLC.
- No known epidermal growth factor receptor (EGFR) mutations.
- Has measurable disease.
- Has not received prior systemic treatment for their advanced/metastatic NSCLC.
- Can provide tumor tissue.
Key exclusion criteria (15 listed)
- Untreated active CNS 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;
- Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first 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. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
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 |
|---|---|---|
| KN046In combine therapy stage, KN046 is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks. | Drug | Experimental arm |
| KN046 placeboIn combine therapy stage, KN046 placebo is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 placebo is 5 milligram per kilogram, every 2 weeks. | Drug | Control arm |
Primary outcome
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging
Time frame: up to 2 years
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Overall Survival (OS)
Time frame: up to 3 years
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up.
1 secondary outcome
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigators
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- 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 3 study testing KN046 in people with Squamous 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 10 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. 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. Some participants in this study may receive a placebo. 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 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?
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?
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging (time frame: up to 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?
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 24 Nov 2021.