Non-Squamous Non-Small Cell Lung CancerPhase 3NCT06847334
A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
A Phase 3 study testing HLX17, US-sourced Keytruda® and EU-sourced Keytruda® in people with Non-Squamous Non-Small Cell Lung Cancer, run by Shanghai Henlius Biotech.
Trial summary
This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- HLX17, US-sourced Keytruda® and EU-sourced Keytruda®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2025to 24 Jan 2028
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.
- Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- At least one measurable lesion as assessed by IRRC based on RECIST v1.1.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Have adequate organ function.
Who cannot join
- Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.
- Subjects with other active malignancies within 5 years or at the same time prior to screening.
- Active central nervous system metastases.
- Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.
- Known active or suspected autoimmune diseases.
- History of immunodeficiency, including HIV antibody positive, active hepatitis B; or hepatitis C virus infections.
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- Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before screening.
- Pregnant or breastfeeding female.
- The investigator has a clear reason to believe that participation in this study would be detrimental to the subject.
About this study
Official title: A Multicentre, Randomized, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of HLX17 Vs. Keytruda® (US-sourced Keytruda® and EU-sourced Keytruda®) in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer.
Read the detailed description
This study includes three treatment groups. Patients will be randomly assigned at a 2:1:1 ratio to the HLX17, US-sourced Keytruda® and EU-sourced Keytruda® group to receive the treatment of IMPs in combination with Carboplatin Plus Pemetrexed until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent form, death, unacceptable toxicity, or up to 17 cycles (whichever occurs first).
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- HLX17, US-sourced Keytruda®, EU-sourced Keytruda®
- Keywords
- Keytruda biosimilar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX17Drug
HLX17 will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.
US-sourced Keytruda®Drug
US-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed. After 24 weeks, all subjects in the US-Keytruda® group will receive HLX17 in combination with Pemetrexed until loss of clinical benefit or up to 1 year.
EU-sourced Keytruda®Drug
EU-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| HLX17 group | Experimental | Recombinant anti-programmed death receptor-1- humanized antibody injection developed by Shanghai Henlius Biotech, Inc. Receives: Drug: HLX17 |
| US-sourced Keytruda® group | Active comparator | US-sourced Keytruda Receives: Drug: US-sourced Keytruda® |
| EU-sourced Keytruda® group | Active comparator | EU-sourced Keytruda Receives: Drug: EU-sourced Keytruda® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d)
Measured: Up to Day 21
Area under the serum concentration-time curve within a dosing interval at steady state (AUCss)
Measured: Up to 1 year
Best Objective Response Rate (BORR) assessed by Independent Radiology Review Committee (IRRC) based on RECIST v1.1
Measured: up to week 24
Secondary outcomes (30)
Maximum serum drug concentration (Cmax) after the first dose
Measured: Up to Day 21
Trough serum drug concentration (Ctrough) after the first dose
Measured: Up to Day 21
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) after the first dose
Measured: Up to Day 21
Area under the serum concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) after the first dose
Measured: Up to Day 21
Time to reach maximum serum drug concentration (Tmax) after the first dose
Measured: Up to Day 21
Elimination half life (t1/2) after the first dose
Measured: Up to Day 21
Volume of distribution during terminal phase (Vz) after the first dose
Measured: Up to Day 21
Total clearance (CL) after the first dose
Measured: Up to Day 21
Mean residence time (MRT) after the first dose
Measured: Up to Day 21
Maximum serum drug concentration at steady-state (Cmax, ss)
Measured: Up to 1 year
Trough serum drug concentration at steady-state (Ctrough, ss)
Measured: Up to 1 year
Average serum drug concentration at steady-state (Cave, ss)
Measured: Up to 1 year
Time to reach maximum serum drug concentration at steady-state (Tmax, ss)
Measured: Up to 1 year
Elimination half life at steady-state (t1/2, ss)
Measured: Up to 1 year
Volume of distribution at steady-state (Vss)
Measured: Up to 1 year
Total clearance at steady-state (CLss)
Measured: Up to 1 year
Accumulation ratio of AUC (Rac(AUC))
Measured: Up to 1 year
Accumulation ratio of Cmax (Rac(Cmax))
Measured: Up to 1 year
Objective response rate (ORR) assessed by IRRC (based on RECIST v1.1)
Measured: Up to Week 24
Objective response rate (ORR) assessed by Investigator (based on RECIST v1.1)
Measured: Up to Week 48
Duration of response (DOR) assessed by the investigator (based on RECIST v1.1)
Measured: Up to Week 48
Time to response (TTR) assessed by the investigator (based on RECIST v1.1)
Measured: Up to Week 48
Progression free survival (PFS) assessed by the investigator (based on RECIST v1.1)
Measured: Up to Week 48
Progression free survival rate (PFSR) assessed by the investigator (based on RECIST v1.1)
Measured: Up to Week 48
Overall survival (OS)
Measured: Up to 1 year
Overall survival rate (OSR)
Measured: Up to 1 year
Adverse events (AEs)
Measured: Up to Month 15
Serious adverse events (SAEs)
Measured: Up to Month 15
Incidence of anti-drug antibodies (ADAs).
Measured: Up to 1 year
Incidence of neutralizing antibodies (NAbs).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start27 Apr 2025 (estimated)
- Primary completion9 Apr 2027 (estimated)
- Study completion24 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847334
- Sponsor's protocol ID
- HLX17-NSCLC301
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of HLX17 Vs. Keytruda® (US-sourced Keytruda® and EU-sourced Keytruda®) in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06847334
- Acronym / sponsor ID
- HLX17-NSCLC301
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Keywords
- Keytruda biosimilar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 772 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2025 (estimated)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 24 Jan 2028 (estimated)
- First posted
- 26 Feb 2025 (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 multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer.
Detailed description
This study includes three treatment groups. Patients will be randomly assigned at a 2:1:1 ratio to the HLX17, US-sourced Keytruda® and EU-sourced Keytruda® group to receive the treatment of IMPs in combination with Carboplatin Plus Pemetrexed until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent form, death, unacceptable toxicity, or up to 17 cycles (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HLX17 group | Experimental | Drug: HLX17Recombinant anti-programmed death receptor-1- humanized antibody injection developed by Shanghai Henlius Biotech, Inc. |
| US-sourced Keytruda® group | Active comparator | Drug: US-sourced Keytruda®US-sourced Keytruda |
| EU-sourced Keytruda® group | Active comparator | Drug: EU-sourced Keytruda®EU-sourced Keytruda |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.
- Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- At least one measurable lesion as assessed by IRRC based on RECIST v1.1.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Key exclusion criteria (9 listed)
- Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.
- Subjects with other active malignancies within 5 years or at the same time prior to screening.
- Active central nervous system metastases.
- Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.
- Known active or suspected autoimmune diseases.
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 |
|---|---|---|
| HLX17HLX17 will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year. | Drug | HLX17 group |
| US-sourced Keytruda®US-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed. After 24 weeks, all subjects in the US-Keytruda® group will receive HLX17 in combination with Pemetrexed until loss of clinical benefit or up to 1 year. | Drug | US-sourced Keytruda® group |
| EU-sourced Keytruda®EU-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year. | Drug | EU-sourced Keytruda® group |
Primary outcome
Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d)
Time frame: Up to Day 21
Area under the serum concentration-time curve within a dosing interval at steady state (AUCss)
Time frame: Up to 1 year
Best Objective Response Rate (BORR) assessed by Independent Radiology Review Committee (IRRC) based on RECIST v1.1
Time frame: up to week 24
30 secondary outcomes
Maximum serum drug concentration (Cmax) after the first dose
Time frame: Up to Day 21
Trough serum drug concentration (Ctrough) after the first dose
Time frame: Up to Day 21
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) after the first dose
Time frame: Up to Day 21
Area under the serum concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) after the first dose
Time frame: Up to Day 21
Time to reach maximum serum drug concentration (Tmax) after the first dose
Time frame: Up to Day 21
Elimination half life (t1/2) after the first dose
Time frame: Up to Day 21
Volume of distribution during terminal phase (Vz) after the first dose
Time frame: Up to Day 21
Total clearance (CL) after the first dose
Time frame: Up to Day 21
Mean residence time (MRT) after the first dose
Time frame: Up to Day 21
Maximum serum drug concentration at steady-state (Cmax, ss)
Time frame: Up to 1 year
Trough serum drug concentration at steady-state (Ctrough, ss)
Time frame: Up to 1 year
Average serum drug concentration at steady-state (Cave, ss)
Time frame: Up to 1 year
Time to reach maximum serum drug concentration at steady-state (Tmax, ss)
Time frame: Up to 1 year
Elimination half life at steady-state (t1/2, ss)
Time frame: Up to 1 year
Volume of distribution at steady-state (Vss)
Time frame: Up to 1 year
Total clearance at steady-state (CLss)
Time frame: Up to 1 year
Accumulation ratio of AUC (Rac(AUC))
Time frame: Up to 1 year
Accumulation ratio of Cmax (Rac(Cmax))
Time frame: Up to 1 year
Objective response rate (ORR) assessed by IRRC (based on RECIST v1.1)
Time frame: Up to Week 24
Objective response rate (ORR) assessed by Investigator (based on RECIST v1.1)
Time frame: Up to Week 48
Duration of response (DOR) assessed by the investigator (based on RECIST v1.1)
Time frame: Up to Week 48
Time to response (TTR) assessed by the investigator (based on RECIST v1.1)
Time frame: Up to Week 48
Progression free survival (PFS) assessed by the investigator (based on RECIST v1.1)
Time frame: Up to Week 48
Progression free survival rate (PFSR) assessed by the investigator (based on RECIST v1.1)
Time frame: Up to Week 48
Overall survival (OS)
Time frame: Up to 1 year
Overall survival rate (OSR)
Time frame: Up to 1 year
Adverse events (AEs)
Time frame: Up to Month 15
Serious adverse events (SAEs)
Time frame: Up to Month 15
Incidence of anti-drug antibodies (ADAs).
Time frame: Up to 1 year
Incidence of neutralizing antibodies (NAbs).
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HLX17, US-sourced Keytruda® and EU-sourced Keytruda® in people with Non-Squamous Non-Small Cell Lung Cancer, run by Shanghai Henlius Biotech.
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 6 inclusion and 9 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
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?
Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) (time frame: Up to Day 21). 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 26 Feb 2025.