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Trial Title:
Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC
NCT ID:
NCT06465238
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A2009
Description:
Treatment group: Subjects will receive an intravenous infusion of SHR-A2009 until
confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the
study.
Arm group label:
Treatment group 1
Intervention type:
Drug
Intervention name:
SHR-A1921
Description:
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 until
confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the
study.
Arm group label:
Treatment group 2
Summary:
This study is an open-label Phase II clinical trial to evaluate the safety and efficacy
of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard
therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary participation and written informed consent;
2. Aged 18-75 years (inclusive), males and females;
3. Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC
(according to 8th AJCC/UICC Classification);
4. Has failed to standard therapy and disease progressed after antibody-conjugated
drugs therapy;
5. Has at least 1 measurable lesion per RECIST 1.1;
6. Patients with ECOG score of 0-1;
7. Life expectancy ≥12 weeks;
8. Have adequate organ function;
9. Participants agrees to use contraception, and be abstinent from heterosexual
intercourse during the treatment period and for ≥180 days after the last dose of
study treatment.
Exclusion Criteria:
1. Histologically or cytologically confirmed presence of small-cell lung cancer or
other benefit-limiting tumor components;
2. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord
compression;
3. Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
4. Subjects who have received systemic anti-tumor treatments prior to the initiation of
the study treatment;
5. Has received major organ surgery or high-intensity thoracic radiotherapy within
before first dose of study therapy；
6. Has a history of a second malignancy;
7. Has a history of non-infectious ILD/pneumonitis that required steroids, or has
current ILD/pneumonitis;
8. Subjects with active pulmonary tuberculosis infection；
9. Serious infection before the first dose；
10. Uncontrolled cardiac diseases or symptoms;
11. Arterial/venous thrombosis events occurred before the first dose；
12. Hypertension that can not be well controlled through antihypertensive drugs，previous
hypertensive crisis or hypertensive encephalopathy；
13. Has a history of active chronic enteritis;
14. Has a history of bleeding prior to the initiation of the study treatment;
15. History of immunodeficiency disease or organ transplant;
16. Subjects with active hepatitis B or active hepatitis C;
17. Has unresolved toxicities from previous anticancer therapy;
18. Has a history of severe hypersensitivity reactions to either the drug substances or
inactive ingredients of SHR-A1921or SHR-A2009;
19. Subjects with other potential factors that may affect the study results or result in
the premature discontinuation as determined by the investigator, such as alcoholism,
drug abuse, other serious diseases (including mental illness) requiring concomitant
treatment, serious laboratory abnormalities, or family or social factors that could
affect the safety of the patients.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan cancer hospital
Address:
City:
Zhengzhou
Country:
China
Contact:
Last name:
Qiming Wang
Start date:
June 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465238
