Squamous Non-small-cell Lung CancerPhase 2NCT04976647
A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
A Phase 2 study testing HLX10+chemo, HLX10+HLX07+chemo and HLX10+HLX07 in people with Squamous Non-small-cell Lung Cancer, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Non-small-cell Lung Cancer
- What is being tested?
- HLX10+chemo, HLX10+HLX07+chemo and HLX10+HLX07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to 30 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer
- EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab
- Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Has a life expectancy of greater than 12 weeks
- Has adequate organ function
Who cannot join
- Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed
- Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy
- EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded
- Has had other active malignancies within 5 years or at the same time
- Has uncontrolled pleural effusion、pericardial effusion or ascites
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wu yilong, phD, (8620)83827812-51486, syylwu@live.cn
About this study
Official title: A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) +HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.
- Conditions
- Squamous Non-small-cell Lung Cancer
- Being tested
- HLX10+chemo, HLX10+HLX07+chemo, HLX10+HLX07
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX10+chemoDrug
HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
HLX10+HLX07+chemoDrug
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
HLX10+HLX07Drug
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;
| Study group | Role | What they receive |
|---|---|---|
| A arm: HLX10+chemo | Active comparator | Participants receive 300mg HLX10 IV every 3 weeks (Q3W) in combination with carboplaitin (AUC5 or 6) IV Q3W and nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle. Receives: Drug: HLX10+chemo |
| B arm: HLX10+HLX07+chemo | Experimental | Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo. Receives: Drug: HLX10+HLX07+chemo |
| C arm: HLX10+HLX07 | Experimental | Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W. Receives: Drug: HLX10+HLX07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by IRRC. ORR will be determined for each treatment arm.
Measured: Up to 5 years
Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by IRRC or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
Measured: Up to 5 years
Secondary outcomes (3)
Adverse Events (AE)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.
Measured: Up to 5 years
Duration of Response (DOR) per RECIST 1.1 assessed by IRRC
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm
Measured: Up to 5 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start18 Jan 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Oct 2024 (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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 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
- NCT04976647
- Sponsor's protocol ID
- HLX10HLX07-sqNSCLC-201
- Status last verified
- May 2022
- First submitted
- 20 Jul 2021
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) +HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
- ClinicalTrials.gov ID
- NCT04976647
- Acronym / sponsor ID
- HLX10HLX07-sqNSCLC-201
- Conditions
- Squamous Non-small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 26 Jul 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.
The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A arm: HLX10+chemo | Active comparator | Drug: HLX10+chemoParticipants receive 300mg HLX10 IV every 3 weeks (Q3W) in combination with carboplaitin (AUC5 or 6) IV Q3W and nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle. |
| B arm: HLX10+HLX07+chemo | Experimental | Drug: HLX10+HLX07+chemoParticipants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo. |
| C arm: HLX10+HLX07 | Experimental | Drug: HLX10+HLX07Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer
- EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab
- Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Has a life expectancy of greater than 12 weeks
Key exclusion criteria (5 listed)
- Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed
- Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy
- EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded
- Has had other active malignancies within 5 years or at the same time
- Has uncontrolled pleural effusion、pericardial effusion or ascites
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 |
|---|---|---|
| HLX10+chemoHLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle | Drug | A arm: HLX10+chemo |
| HLX10+HLX07+chemoHLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle | Drug | B arm: HLX10+HLX07+chemo |
| HLX10+HLX07HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; | Drug | C arm: HLX10+HLX07 |
Primary outcome
Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC
Time frame: Up to 5 years
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by IRRC. ORR will be determined for each treatment arm.
Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
Time frame: Up to 5 years
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by IRRC or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
3 secondary outcomes
Adverse Events (AE)
Time frame: Up to 5 years
Duration of Response (DOR) per RECIST 1.1 assessed by IRRC
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
Related trials for Squamous Non-small-cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX10+chemo, HLX10+HLX07+chemo and HLX10+HLX07 in people with Squamous Non-small-cell Lung Cancer, run by Shanghai Henlius Biotech 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 6 inclusion and 5 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 6 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC (time frame: Up to 5 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 6 May 2022.