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

NCT06754644 | Recruiting Phase 3

• 1 other identifier: QL2107-301-CN
• Study Type: interventional
• Target: 808
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• clinical equivalence

  The 24-week objective response rate (24-week ORR, defined as the proportion of subjects who achieve CR or PR based on best efficacy at any time within 24 weeks after administration, evaluated according to RECIST 1.1) assessed by the Independent Review Committee (IRC)

  24-week

Study Arms (2)

QL2107

EXPERIMENTAL

Drug: QL2107; Drug: Pemetrexed; Drug: Carboplatin

Keytruda®

ACTIVE COMPARATOR

Drug: Pemetrexed; Drug: Carboplatin; Drug: Keytruda®

Interventions

QL2107 DRUG

200mg on day 1 of each 21-day cycle of the study

QL2107

Pemetrexed DRUG

500 mg/m2 on Day 1 of each 21-day cycle of the study

Keytruda®; QL2107

Carboplatin DRUG

Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles

Keytruda®; QL2107

Keytruda® DRUG

200mg on day 1 of each 21-day cycle of the study

Keytruda®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong First Medical University Cancer Hospital

Jinan, Shandong, China

RECRUITING

MeSH Terms

Interventions

Pemetrexed; Carboplatin; pembrolizumab

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Central Study Contacts

Jinming Yu, PhD

CONTACT

0531-67626971; sdyujinming@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2024-12

Locations

CN (1)