NCT06585059Not yet recruitingPhase 1
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 Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers
Source: ClinicalTrials.gov · Last updated 5 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 Sept 2024
- Start date
- Sept 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06585059
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From Sept 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
- 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.
Other illness
- A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
- Subjects with any severe and/or uncontrolled disease;
Other
- Long-term unhealed wounds or fractures;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.