QL2107 plus chemotherapy versus Keytruda for metastatic non-squamous NSCLC

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 is a Phase 3, interventional comparison of QL2107 combined with pemetrexed and carboplatin against Keytruda with chemotherapy in patients with stage IV non-squamous NSCLC. Eligible participants are adults 18–75 years old with confirmed metastatic non-squamous disease, ECOG 0–1, no EGFR sensitive mutations or ALK translocations, and an expected survival of at least three months. The trial focuses on measuring treatment efficacy and safety outcomes to determine whether QL2107 produces similar clinical results to pembrolizumab when given with standard chemotherapy. Treatments are administered at an investigational site in Jinan, Shandong, with regular clinic visits for dosing, monitoring, and outcome assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects who voluntarily participate, sign the Informed Consent Form (ICF), and are able to comply with the study procedures;
* Subjects aged ≥ 18 and ≤ 75 years at enrollment, male or female;
* Histologically or cytologically confirmed metastatic (stage IV) non-squamous NSCLC as per the American Joint Committee on Cancer (AJCC) 8th Edition; if multiple tumor histologies are present, the predominant cell type should be classified;
* No EGFR sensitive mutations or ALK gene translocations.
* Expected survival ≥ 3 months;
* Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1;

Exclusion Criteria:

* Pulmonary radiation therapy \> 30 Gy within 6 months prior to the first dose;
* Palliative radiation therapy completed within 7 days prior to the first dose;
* Any other form of anti-tumor therapy expected to be required during the study;
* Uncontrolled or symptomatic pericardial effusion, pleural effusion and ascites requiring repeated paracentesis and drainage;
* Presence of metastases to brain stem, meninges and spinal cord or compression;

Where it's running

• Shandong First Medical University Cancer Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Jinming Yu, PhD
• Email: sdyujinming@126.com
• Phone: 0531-67626971

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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.