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

Phase 3

Not yet recruiting

• Conditions: NSCLC
• Interventions: Drug: QL2107; Drug: Pemetrexed; Drug: Carboplatin; Drug: Keytruda®

• Registration Number: NCT06754644
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study Start: 2025-01
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 464

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL2107	QL2107	-
QL2107	Pemetrexed	-
QL2107	Carboplatin	-
Keytruda®	Pemetrexed	-
Keytruda®	Carboplatin	-
Keytruda®	Keytruda®	-

Primary Outcome Measures

Name	Time	Method
clinical equivalence	18-week	The 18-week objective response rate (18-week ORR, defined as the proportion of subjects who achieve CR or PR based on best efficacy at any time within 18 weeks after administration, evaluated according to RECIST 1.1) assessed by the Independent Review Committee (IRC)