NSCLCPhase 3NCT06754644
A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC
A Phase 3 study testing QL2107, Pemetrexed and Carboplatin in people with NSCLC, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- QL2107, Pemetrexed and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 808 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong First Medical University Cancer Hospital
Jinan, Shandong
Jinming Yu, 0531-67626971, sdyujinming@126.com
About this study
Official 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
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
- Conditions
- NSCLC
- Being tested
- QL2107, Pemetrexed, Carboplatin, Keytruda®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2107Drug
200mg on day 1 of each 21-day cycle of the study
PemetrexedDrug
500 mg/m2 on Day 1 of each 21-day cycle of the study
CarboplatinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| QL2107 | Experimental | Not described Receives: Drug: QL2107; Drug: Pemetrexed; Drug: Carboplatin |
| Keytruda® | Active comparator | Not described Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: Keytruda® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start15 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 808 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754644
- Sponsor's protocol ID
- QL2107-301-CN
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06754644
- Acronym / sponsor ID
- QL2107-301-CN
- Conditions
- NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 808 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL2107 | Experimental | Drug: QL2107, Drug: Pemetrexed, Drug: Carboplatin |
| Keytruda® | Active comparator | Drug: Pemetrexed, Drug: Carboplatin, Drug: Keytruda® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL2107200mg on day 1 of each 21-day cycle of the study | Drug | QL2107 |
| Pemetrexed500 mg/m2 on Day 1 of each 21-day cycle of the study | Drug | Keytruda®, QL2107 |
| CarboplatinTarget AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles | Drug | Keytruda®, QL2107 |
| Keytruda®200mg on day 1 of each 21-day cycle of the study | Drug | Keytruda® |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL2107, Pemetrexed and Carboplatin in people with NSCLC, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinming Yu, PhD (0531-67626971, sdyujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical equivalence (time frame: 24-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.