Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor… (NCT06585059) | Clinical Trial Compass
Not 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
China20 participantsStarted 2024-09
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 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 all…
What they're measuring
1
Phase II recommended combination doses (RP2CD)
Timeframe: Baseline up to 24 months
2
Objective Response Rate (ORR)
Timeframe: Up to 2 years
3
Duration of Response (DOR)
Timeframe: Up to 2 years
4
Progression-free survival (PFS)
Timeframe: Up to 2 years
5
Time to Progression
Timeframe: Up to 2 years
Trial details
NCT IDNCT06585059
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.