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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QL2107

Group Type EXPERIMENTAL

QL2107

Intervention Type DRUG

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

Pemetrexed

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Keytruda®

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Keytruda®

Intervention Type DRUG

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

Interventions

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QL2107

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

Intervention Type DRUG

Pemetrexed

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

Intervention Type DRUG

Carboplatin

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

Intervention Type DRUG

Keytruda®

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

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No