NSCLC
Conditions
Brief summary
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Interventions
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who voluntarily participate, sign the Informed Consent Form (ICF), and are able to comply with the study procedures; * Subjects aged ≥ 18 and ≤ 75 years at enrollment, male or female; * Histologically or cytologically confirmed metastatic (stage IV) non-squamous NSCLC as per the American Joint Committee on Cancer (AJCC) 8th Edition; if multiple tumor histologies are present, the predominant cell type should be classified; * No EGFR sensitive mutations or ALK gene translocations. * Expected survival ≥ 3 months; * Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1;
Exclusion criteria
* Pulmonary radiation therapy \> 30 Gy within 6 months prior to the first dose; * Palliative radiation therapy completed within 7 days prior to the first dose; * Any other form of anti-tumor therapy expected to be required during the study; * Uncontrolled or symptomatic pericardial effusion, pleural effusion and ascites requiring repeated paracentesis and drainage; * Presence of metastases to brain stem, meninges and spinal cord or compression;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical equivalence | 24-week | The 24-week objective response rate (24-week ORR, defined as the proportion of subjects who achieve CR or PR based on best efficacy at any time within 24 weeks after administration, evaluated according to RECIST 1.1) assessed by the Independent Review Committee (IRC) |
Countries
China
Contacts
Primary ContactJinming Yu, PhD
Outcome results
None listed