A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer

NCT05690945 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: QL1706-303
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

Brief 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 304 subjects in the experimental group and the control group.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• OS

  Overall Survival (OS) in the ITT population determined by the investigator

  From date of randomization until the date of death from any cause, which ever came first, assessed up to 2 years

Secondary Outcomes (4)

• ORR

  First administration until disease progression or death, which ever occurs first (up to approximately 24 months)

• DOR

  First administration until disease progression or death, which ever occurs first (up to approximately 24 months)

• DCR

  First administration until disease progression or death, which ever occurs first (up to approximately 24 months)

• PFS

  Informed consent until disease progression or death, which ever occurs first (up to approximately 2 years)

Study Arms (2)

QL1706+chemotherapy

EXPERIMENTAL

Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive QL1706, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706 or QL1706 combined with pemetrexed.

Drug: QL1706

Tiselizumab+chemotherapy

ACTIVE COMPARATOR

Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive tiselizumab, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with tiselizumab or tiselizumab combined with pemetrexed.

Drug: Tilesizumab

Interventions

QL1706 DRUG

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.

Also known as: PSB205

QL1706+chemotherapy

Tilesizumab DRUG

Tilesizumab will be administered by IV infusion at 200mg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.

Also known as: BGB-108

Tiselizumab+chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be≥18 to ≤ 75 years of age at enrollment, male or female.
• 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).
• No EGFR sensitive mutations or ALK gene translocation alterations.
• 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% .
• Have a life expectancy of at least 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• No prior systemic therapy for advanced or metastatic NSCLC was received.

You may not qualify if:

• 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.
• Patients who have received systemic corticosteroids or other immunosuppressive drugs within 2 weeks prior to the first dose.
• 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.
• Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose;
• Palliative radiotherapy completed 7 days prior to first dose.
• Known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis during screening.
• Clinically significant cardiovascular or cerebrovascular disease

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Zhang, Professor

  Sun Yat-sen Univeisity Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: February 15, 2023
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-03

Locations

CN (1)