A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: NSCLC

Treatments: Drug: Keytruda®; Drug: QL2107; Drug: Carboplatin; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT06754644

QL2107-301-CN

Details and patient eligibility

About

The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.

Enrollment: 808 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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808 participants in 2 patient groups

QL2107

Experimental group

Treatment:

Drug: Pemetrexed

Drug: Carboplatin

Drug: QL2107

Keytruda®

Active Comparator group

Treatment:

Drug: Pemetrexed

Drug: Carboplatin

Drug: Keytruda®