Evaluating QL1706 with chemotherapy for lung cancer

A Randomized, Double-blind, Multicenter Phase 3 Clinical Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Chemotherapy in First-line PD-L1 Negative, Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

This study is testing if a new drug called QL1706 works better with chemotherapy than another treatment for people with advanced lung cancer that has a specific marker.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 608 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation, tislelizumab, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05690945 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of QL1706 in combination with platinum-based chemotherapy compared to tislelizumab with chemotherapy in patients with PD-L1 negative, locally advanced or metastatic non-small cell lung cancer (NSCLC). It is a randomized, double-blind, active-controlled Phase 3 clinical trial involving approximately 608 patients, who will be randomly assigned to either the experimental or control group. Participants will be stratified based on factors such as tumor type and presence of brain metastasis to ensure balanced groups for analysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced or metastatic NSCLC that is PD-L1 negative and who have not received prior systemic therapy.

Not a fit: Patients with EGFR sensitive mutations, ALK gene translocations, or those who have previously been treated with immune checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with PD-L1 negative NSCLC, potentially improving outcomes in this challenging population.

How similar studies have performed: Other studies have explored similar combinations of chemotherapy and immunotherapy, but the specific approach of QL1706 in this context is novel.

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

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Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Li Zhang, Professor — Sun Yat-sen Univeisity Cancer Center
• Study coordinator: Wenying Zhao

Conditions Lung Cancer