Advanced Non-small Cell Lung CancerPhase 1NCT06585059
Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers
A Phase 1 study testing TQB2928 injection + Almonertinib Mesilate Tablets in people with Advanced Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- TQB2928 injection + Almonertinib Mesilate Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Dec 2026
- Phase
- Phase 1
- 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
- Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months；
- Locally advanced or metastatic NSCLC diagnosed by histology or cytology
- The major organs are functioning well；
- Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study；
- Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.
Who cannot join
- Current concomitant presence of other malignancies within 5 years prior to the first dose;
- Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;
- Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
- Long-term unhealed wounds or fractures;
- Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
- A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
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- Subjects with any severe and/or uncontrolled disease;
- History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
- Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928 injection or excipients in pharmaceutical formulations;
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, Doctor, 020-87343458, Zhangli@syscc.cn
Wenfeng Fang, Doctor, 15322302066, fangwf@sysucc.org.cn
About this study
Official title: A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers
This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- TQB2928 injection + Almonertinib Mesilate Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2928 injection + Almonertinib Mesilate TabletsDrug
TQB2928 is a recombinant fully humanized Immunoglobulin G4 (IgG4) monoclonal antibody that can promote tumor cell phagocytosis by macrophages and exert anti-tumor effects.
Almonertinib Mesilate Tablets is a third generation of EGFR-TKI targeting drug.
| Study group | Role | What they receive |
|---|---|---|
| TQB2928 injection + Almonertinib Mesilate Tablets | Experimental | Every 3 weeks constitutes one treatment cycle. For the first 2 cycles, TQB2928 is administered via infusion once a week. Starting from the 3rd cycle, TQB2928 is administered once every 3 weeks. Amivantamab is taken orally at a fixed time daily. Receives: Drug: TQB2928 injection + Almonertinib Mesilate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II recommended combination doses (RP2CD)
The recommended dosage for drug combination therapy in the second phase of clinical trials (i.e. Phase II clinical trials).
Measured: Baseline up to 24 months
Objective Response Rate (ORR)
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Measured: Up to 2 years
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression.
Measured: Up to 2 years
Progression-free survival (PFS)
Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.
Measured: Up to 2 years
Time to Progression
The time from randomization to obtaining the first objective relief.
Measured: Up to 2 years
Secondary outcomes (7)
Elimination half-life (t1/2)
The time required for plasma drug concentration to decrease by half.
Measured: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Area under the plasma concentration-time curve (AUC0-last)
The area enclosed by the plasma concentration curve against the timeline.
Measured: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Apparent Plasma Clearance (CL)
Apparent plasma clearance of TQB2928.
Measured: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Apparent volume of distribution(Vz)
The ratio of the amount of TQB2928 in the body to the blood concentration.
Measured: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Steady-state trough concentration (Css-min)
Minimum concentration during dosing.
Measured: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Immunogenicity: anti-drug antibody (ADA)
Incidence of anti-drug antibody (ADA).
Measured: From the time of informed consent signed through 90 days after the last dose
Adverse Events (AE) rate
The occurrence and severity of all AEs.
Measured: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
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 Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585059
- Sponsor's protocol ID
- TQB2928-Ib-03
- Status last verified
- Jun 2024
- First submitted
- 1 Sep 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers
- ClinicalTrials.gov ID
- NCT06585059
- Acronym / sponsor ID
- TQB2928-Ib-03
- Conditions
- Advanced Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Sep 2024 (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 Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2928 injection + Almonertinib Mesilate Tablets | Experimental | Drug: TQB2928 injection + Almonertinib Mesilate TabletsEvery 3 weeks constitutes one treatment cycle. For the first 2 cycles, TQB2928 is administered via infusion once a week. Starting from the 3rd cycle, TQB2928 is administered once every 3 weeks. Amivantamab is taken orally at a fixed time daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months；
- Locally advanced or metastatic NSCLC diagnosed by histology or cytology
- The major organs are functioning well；
- Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study；
- Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.
Key exclusion criteria (10 listed)
- Current concomitant presence of other malignancies within 5 years prior to the first dose;
- Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;
- Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
- Long-term unhealed wounds or fractures;
- Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
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 |
|---|---|---|
| TQB2928 injection + Almonertinib Mesilate TabletsTQB2928 is a recombinant fully humanized Immunoglobulin G4 (IgG4) monoclonal antibody that can promote tumor cell phagocytosis by macrophages and exert anti-tumor effects. Almonertinib Mesilate Tablets is a third generation of EGFR-TKI targeting drug. | Drug | TQB2928 injection + Almonertinib Mesilate Tablets |
Primary outcome
Phase II recommended combination doses (RP2CD)
Time frame: Baseline up to 24 months
The recommended dosage for drug combination therapy in the second phase of clinical trials (i.e. Phase II clinical trials).
Objective Response Rate (ORR)
Time frame: Up to 2 years
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Duration of Response (DOR)
Time frame: Up to 2 years
Defined as the time from first documented response to documented disease progression.
Progression-free survival (PFS)
Time frame: Up to 2 years
Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.
Time to Progression
Time frame: Up to 2 years
The time from randomization to obtaining the first objective relief.
7 secondary outcomes
Elimination half-life (t1/2)
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Area under the plasma concentration-time curve (AUC0-last)
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Apparent Plasma Clearance (CL)
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Apparent volume of distribution(Vz)
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Steady-state trough concentration (Css-min)
Time frame: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)
Immunogenicity: anti-drug antibody (ADA)
Time frame: From the time of informed consent signed through 90 days after the last dose
Adverse Events (AE) rate
Time frame: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first
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 5 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2928 injection + Almonertinib Mesilate Tablets in people with Advanced Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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 5 inclusion and 10 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 5 Sep 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 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.
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?
Contact Li Zhang, Doctor (020-87343458, Zhangli@syscc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II recommended combination doses (RP2CD) (time frame: Baseline up to 24 months). The study lists 5 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 5 Sep 2024.