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RecruitingNCT06754644Updated Jun 10, 2025

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

A Phase 3 interventional study of QL2107 and Pemetrexed in NSCLC, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
808
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • NSCLC
03

In context

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
808 participants (estimated)

Study arms

  • Experimental
    QL2107

    Drug: QL2107 · Drug: Pemetrexed · Drug: Carboplatin

  • Active comparator
    Keytruda®

    Drug: Pemetrexed · Drug: Carboplatin · Drug: Keytruda®

Interventions

  • DrugQL2107

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

  • DrugPemetrexed

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

  • DrugCarboplatin

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

  • DrugKeytruda®

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

06

What researchers measure

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)

    Time frame: 24-week

07

Study locations

1 of 1 sites recruiting
  • Shandong First Medical University Cancer Hospital
    Jinan, Shandong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06754644
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 1, 2025
Start date
Jan 15, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 10, 2025

Study contacts

Jinming Yu, PhD
Contact
sdyujinming@126.com
0531-67626971

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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