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

June 5, 2025 updated by: Qilu Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

808

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL2107
Drug: Pemetrexed
500 mg/m2 on Day 1 of each 21-day cycle of the study
Drug: Carboplatin
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
Drug: QL2107
200mg on day 1 of each 21-day cycle of the study
Active Comparator: Keytruda®
Drug: Pemetrexed
500 mg/m2 on Day 1 of each 21-day cycle of the study
Drug: Carboplatin
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
Drug: Keytruda®
200mg on day 1 of each 21-day cycle of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical equivalence
Time Frame: 24-week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL2107-301-CN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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