QL2107 plus chemotherapy versus Keytruda for metastatic non-squamous NSCLC

A Randomized, Double-blind, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of QL2107 Versus Keytruda® in Combination With Chemotherapy in the Treatment of Metastatic Non-squamous Non-small-cell Lung Cancer

This test will see if giving QL2107 with pemetrexed and carboplatin works as well as Keytruda (pembrolizumab) with chemotherapy for adults with metastatic non-squamous non-small cell lung cancer who do not have EGFR or ALK mutations.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 808 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06754644 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed stage IV non-squamous NSCLC, ECOG performance status 0–1, no EGFR sensitive mutations or ALK translocations, and an expected survival of at least three months are ideal candidates.

Not a fit: Patients with EGFR sensitive mutations or ALK translocations, poor performance status (ECOG ≥2), those who recently had high-dose pulmonary radiation, or those requiring other concurrent anti-tumor therapies are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, QL2107 could offer an alternative immune therapy option comparable to Keytruda, potentially increasing treatment choices and access for patients.

How similar studies have performed: Other PD-1/PD-L1 inhibitors given with chemotherapy, including pembrolizumab, have shown benefit in similar metastatic non-squamous NSCLC populations, so the general approach has clinical precedent.

Eligibility criteria

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 this trial is running

Jinan, Shandong

• Shandong First Medical University Cancer Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Jinming Yu, PhD

Conditions NSCLC