Carcinoma, Non-Small-Cell LungPhase 3NCT05487391

A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.

A Phase 3 study testing QL1706 injection, Vinorelbine Tartrate and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: QL1706 injection, Vinorelbine Tartrate and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 632 participants
Where: 1 siteChina
Study dates: 8 Dec 2022to 22 May 2029
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.
Histopathologically confirmed squamous or non-squamous non-small cell lung cancer
Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment.
Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.
Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug.

Who cannot join

Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment.
Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.
Cardiovascular and cerebrovascular diseases with clinical significance.
Gastrointestinal disease of clinical significance.
Clinically significant lung damage.
Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.

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Active uncontrolled hepatitis B or active hepatitis C.
Administer a live vaccine within 30 days prior to the first dose of study treatment.
Other malignancies occurred within 5 years prior to study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)
Previously allergic to macromolecular protein preparations, or to any component of QL1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin) or their preventive drugs, etc.
History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiusong Qiu contact

86-13918736645

xiusong.qiu@qilu-pharma.com

China1 site, 1 recruiting

Shanghai Pulmonary Hospital, Shanghai. China
Shanghai
Caicun Zhou
Recruiting

Other trials in China

About this study

Official title: QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: QL1706 injection, Vinorelbine Tartrate, Paclitaxel, Cisplatin, Carboplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QL1706 injectionDrug
QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
Vinorelbine TartrateDrug
Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles
PaclitaxelDrug
Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles
CisplatinDrug
Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles
CarboplatinDrug
Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles
PemetrexedDrug
Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles
PlaceboDrug
Placebo

Study groups in NCT05487391
Study group	Role	What they receive
QL1706 plus Platinum-based chemotherapy	Experimental	QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy Receives: Drug: QL1706 injection; Drug: Vinorelbine Tartrate; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed
Placebo plus Platinum-based chemotherapy	Placebo comparator	Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy Receives: Drug: Vinorelbine Tartrate; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator.
DFS was defined as the time from randomization to first recurrence of NSCLC, appearance of new primary NSCLC, or death from any cause, whichever occurred first. Tumor recurrence includes local recurrence and distant metastasis.
Measured: Up to approximately 84 months
Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator.
Measured: Up to approximately 84 months

Secondary outcomes (6)

Overall Survival (OS)
OS is defined as the time from random to death from any cause. OS will be measured in the PD-L1 subpopulation and in the ITT population.
Measured: Up to approximately 108 months
Percentage of Participants Who are Survival at Year 4
OS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Measured: Year 4
Percentage of Participants Who are Disease-Free at Year 3
DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Measured: Year 3
Percentage of Participants Who are Disease-Free at Year 5
DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Measured: Year 5
DFS Within Selected Populations
Assessed by Investigator
Measured: Up to approximately 108 months
Percentage of Participants with Adverse Events and Serious Adverse Events
Measured: Up to approximately 108 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 202222 May 2029

First posted4 Aug 2022
Study start8 Dec 2022
Primary completion31 Aug 2027 (estimated)
Study completion22 May 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Carcinoma, Non-Small-Cell LungStudies 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: 632 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05487391
Sponsor's protocol ID: QL1706-304
Status last verified: Oct 2024
First submitted: 1 Aug 2022
Last updated: 15 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.
PubMed 37158938

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.
ClinicalTrials.gov ID: NCT05487391
Acronym / sponsor ID: QL1706-304
Conditions: Carcinoma, Non-Small-Cell Lung
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 632 participants (estimated)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Dec 2022 (actual)
Primary completion: 31 Aug 2027 (estimated)
Study completion: 22 May 2029 (estimated)
First posted: 4 Aug 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
QL1706 plus Platinum-based chemotherapy	Experimental	Drug: QL1706 injection, Drug: Vinorelbine Tartrate, Drug: Paclitaxel, Drug: Cisplatin, Drug: Carboplatin, Drug: PemetrexedQL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
Placebo plus Platinum-based chemotherapy	Placebo comparator	Drug: Vinorelbine Tartrate, Drug: Paclitaxel, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: PlaceboPlacebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.
Histopathologically confirmed squamous or non-squamous non-small cell lung cancer
Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment.
Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.
Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene.

Key exclusion criteria (11 listed)

Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment.
Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.
Cardiovascular and cerebrovascular diseases with clinical significance.
Gastrointestinal disease of clinical significance.
Clinically significant lung damage.

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
QL1706 injectionQL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy	Drug	QL1706 plus Platinum-based chemotherapy
Vinorelbine TartrateVinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles	Drug	Placebo plus Platinum-based chemotherapy, QL1706 plus Platinum-based chemotherapy
PaclitaxelPaclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles	Drug	Placebo plus Platinum-based chemotherapy, QL1706 plus Platinum-based chemotherapy
CisplatinCisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles	Drug	Placebo plus Platinum-based chemotherapy, QL1706 plus Platinum-based chemotherapy
CarboplatinCarboplatin AUC=5（D1） Q3W IV, 2-4 cycles	Drug	Placebo plus Platinum-based chemotherapy, QL1706 plus Platinum-based chemotherapy
PemetrexedPemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles	Drug	Placebo plus Platinum-based chemotherapy, QL1706 plus Platinum-based chemotherapy
PlaceboPlacebo	Drug	Placebo plus Platinum-based chemotherapy

Primary outcome

Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator.
Time frame: Up to approximately 84 months
DFS was defined as the time from randomization to first recurrence of NSCLC, appearance of new primary NSCLC, or death from any cause, whichever occurred first. Tumor recurrence includes local recurrence and distant metastasis.
Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator.
Time frame: Up to approximately 84 months

6 secondary outcomes

Overall Survival (OS)
Time frame: Up to approximately 108 months
Percentage of Participants Who are Survival at Year 4
Time frame: Year 4
Percentage of Participants Who are Disease-Free at Year 3
Time frame: Year 3
Percentage of Participants Who are Disease-Free at Year 5
Time frame: Year 5
DFS Within Selected Populations
Time frame: Up to approximately 108 months
Percentage of Participants with Adverse Events and Serious Adverse Events
Time frame: Up to approximately 108 months

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 15 Oct 2024.
Derived from this study: PubMed 37158938Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.

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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.

Xiusong Qiu contact

86-13918736645

xiusong.qiu@qilu-pharma.com

Caicun Zhou, MD, PhD study chair

Shanghai Pulmonary Hospital, Shanghai, China

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 QL1706 injection, Vinorelbine Tartrate and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung, 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 7 inclusion and 11 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 15 Oct 2024. 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. Some participants in this study may receive a placebo. 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 Xiusong Qiu (86-13918736645, xiusong.qiu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator. (time frame: Up to approximately 84 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05487391, which also lists 1 linked publication.

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 15 Oct 2024.