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Recruiting Phase 3

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

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About this study

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

Condition
NSCLC
Tested
QL2107, Pemetrexed, Carboplatin, Keytruda®
Sponsor
Qilu Pharmaceutical Co., Ltd.

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: NSCLC
  • 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 5

  • 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;

Where

1 site, 1 recruiting

Shandong First Medical University Cancer Hospital

Jinan, Shandong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.