New hope for lung cancer patients with no PD-L1 marker
NCT ID NCT05690945
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new drug called QL1706, combined with chemotherapy, works better than another drug (tislelizumab) plus chemo for people with advanced non-small cell lung cancer that lacks the PD-L1 protein. About 606 adults aged 18-75 are taking part. The goal is to see if the new combo helps people live longer and controls the cancer better.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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606 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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