Evaluating QL1706 with chemotherapy for lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

   -

Where it's running

• 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
• Email: wenying.zhao@qilu-pharma.com
• Phone: 86-18202912662

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ePRO in advanced lung cancer: emotional distress, brain metastasis, and symptom burden

  This study tests how patients with advanced lung cancer—some with brain metastases—report emotional distress and symptoms over time using electronic questionnaires.

  Recruiting Tongji Hospital · Hubei, Wuhan · NCT07912190

• Urine VOC Test to Detect Lung Cancer in Never Smokers

  A urine test that looks for volatile compounds is tested to see if it can help detect lung cancer in adults who have never smoked.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07871656

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Guaraná Supplement for Cancer-Related Fatigue in People Undergoing Treatment

  This study tests whether taking guaraná capsules helps reduce cancer-related fatigue and improve quality of life in adults with breast, lung, colorectal, or gastric cancer who are actively receiving treatment.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07816263

• ENPP1/cGAS and FAP in Solid Tumors in Vietnamese Patients

  This Vietnam-based study will test ENPP1, cGAS, and FAP expression in archived tumor samples from Vietnamese adults with solid cancers using immunohistochemistry.

  Recruiting at 2 sites Tam Anh Research Institute · Hanoi, Hanoi and 1 other locations · NCT07808164

• Olive oil before lung cancer surgery to see if it lowers chylothorax

  This study tests whether drinking 40 mL of extra-virgin olive oil a few hours before lung cancer surgery can reduce chylothorax after tumor removal.

  Recruiting Fudan University · Shanghai, Xuhui · NCT07807696

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.