A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality (NCT06496490) | Clinical Trial Compass
RecruitingPhase 2
A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality
China270 participantsStarted 2024-08-06
Plain-language summary
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in locally advanced or metastatic non-small cell lung cancer with HER2 gene abnormality.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subjects voluntarily participate in this study and sign informed consent;
* Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
* Patients with locally advanced, metastatic, or recurrent non-small cell lung cancer that is cytologically or histologically proven to be inoperable and cannot be treated with radical concurrent chemoradiotherapy;
* Previous standard treatments failedï¼›
* At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
* Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.
Exclusion Criteria:
* Has diagnosed and/or treated additional malignancy within 3 years prior to take medication;
* Adverse effects due to any prior treatment have not been restored to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
* Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment,and minor traumatic surgery (biopsy, bronchoscopy, and chest drainage) …
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Baseline up to 8 months
Trial details
NCT IDNCT06496490
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.