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Trial Title:
A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer
NCT ID:
NCT05690945
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
QL1706
Description:
QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until
unacceptabletoxicity or loss of clinical benefit.
Arm group label:
QL1706+chemotherapy
Other name:
PSB205
Intervention type:
Drug
Intervention name:
Tilesizumab
Description:
Tilesizumab will be administered by IV infusion at 200mg on Day 1 of each 21-day cycle
until unacceptabletoxicity or loss of clinical benefit.
Arm group label:
Tiselizumab+chemotherapy
Other name:
BGB-108
Summary:
The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with
platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy
in PD-L1 negative, locally advanced or metastatic Non-small Cell Lung Cancer Patients.
The subjects were randomly divided into two groups according to 1:1, with about 325
subjects in the experimental group and the control group.
Detailed description:
This study was a randomized, double-blind, active-controlled, multicenter Phase 3
clinical study. The study is designed to evaluate the efficacy and safety of QL1706 in
combination with chemotherapy or commercial PD1 in combination with chemotherapy in
locally advanced or metastatic NSCLC patients who are PD-L1 negative.650 patients would
be enrolled . Subjects will be assigned randomly in a 1:1 ratio to experimental group and
control group. Subjects will be stratified by pathological type: squamous cell carcinoma
versus non-squamous cell carcinoma; brain metastasis: present versus absent; gender: male
versus female. After randomization, subjects will be treated according to the
randomization results.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be≥18 to ≤ 75 years of age at enrollment, male or female.
2. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that
not amenable to complete surgical resection and not amenable to radical
concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint
Committee on Cancer [AJCC] 8th edition).
3. No EGFR sensitive mutations or ALK gene translocation alterations.
4. Capable of providing fresh or archived 2 years' tissue samples collected at
post-diagnosis or non-radiation sites at diagnosis for central laboratory PD-L1
testing with TPS < 1% .
5. Have a life expectancy of at least 3 months.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. No prior systemic therapy for advanced or metastatic NSCLC was received.
Exclusion Criteria:
1. Previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 drugs or drugs
acting on another T cell receptor (e.g., CTLA-4 etc.), as well as immune checkpoint
agonistic antibodies (e.g., anti ICOS , CD40 , CD137 , GITR , OX40 antibodies,
etc.), and immune cell therapy.
2. Patients who have received systemic corticosteroids or other immunosuppressive drugs
within 2 weeks prior to the first dose.
3. Presence or history of any active autoimmune disease, including, but not limited to:
autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis,
enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism,
hypothyroidism.
4. Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose;
5. Palliative radiotherapy completed 7 days prior to first dose.
6. Known or symptomatic active central nervous system (CNS) metastases or carcinomatous
meningitis during screening.
7. Clinically significant cardiovascular or cerebrovascular disease
-
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
February 1, 2023
Completion date:
June 23, 2025
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690945
