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NCT Number: NCT06754644

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

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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shandong First Medical University Cancer Hospital

Jinan, Shandong, China

Location status: Recruiting

Location contact

Jinming Yu

CONTACT

[email protected]

0531-67626971

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

QL2107

Drug

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

Pemetrexed

Drug

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

carboplatin

Drug

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

Keytruda®

Drug

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

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jinming Yu, PhD

CONTACT

[email protected]

0531-67626971

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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