Non-Small Cell Lung CancerNCT07452003
An Exploratory Study of QL1706 Plus Chemotherapy in Perioperative NSCLC
A study testing QL1706 plus chemotherapy in people with Non-Small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, single-arm phase II exploratory study evaluating a perioperative regimen of iparomlimab and tuvonralimab (QL1706; a bispecific PD-1/CTLA-4 antibody) combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage IIB-IIIB non-small cell lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- QL1706 plus chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2026to Dec 2029
- Phase
- Interventional
- 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
- Patients are eligible for enrollment in this study only if they meet all of the following inclusion criteria and none of the exclusion criteria:
- The subject voluntarily participates in the study, provides written informed consent, demonstrates good compliance, and is willing to cooperate with study procedures and follow-up.
- Age ≥18 years at the time of signing the informed consent form; sex not restricted.
- Histologically confirmed non-small cell lung cancer (NSCLC).
- At least one measurable lesion according to RECIST version 1.1 (measurable lesion defined as a longest diameter ≥10 mm on spiral CT scan, or lymph node with a short axis ≥15 mm).
- No prior systemic therapy or local treatment for NSCLC.
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- TNM stage IIB to IIIB disease, assessed by surgeons as resectable or potentially resectable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Pulmonary function within normal limits.
- Adequate hematologic and organ function, based on laboratory tests obtained within 14 days prior to initiation of study treatment (unless otherwise specified):
- Hematology (no blood transfusion, G-CSF, or corrective medications within 14 days prior to screening):
- Hemoglobin ≥90 g/L
- Absolute neutrophil count ≥1.5 × 10⁹/L
- Platelet count ≥100 × 10⁹/L
- Biochemistry (no albumin infusion within 14 days prior to screening):
- ALT and AST ≤2.5 × upper limit of normal (ULN)
- Total bilirubin ≤2.0 × ULN (this criterion does not apply to patients with confirmed Gilbert's syndrome)
- Renal function:
- Serum creatinine ≤1.5 × ULN, or
- Creatinine clearance (CrCl) >50 mL/min calculated using the Cockcroft-Gault formula:
- Females: CrCl = ((140 - age) × weight (kg) × 0.85) / (72 × serum creatinine [mg/dL])
- Males: CrCl = ((140 - age) × weight (kg) × 1.00) / (72 × serum creatinine [mg/dL])
- Women of childbearing potential must agree to remain abstinent (avoid heterosexual intercourse) or use highly effective contraception with a failure rate <1% per year during study treatment and for at least 6 months after the last dose.
- Women are considered of childbearing potential if they are menstruating, not postmenopausal (defined as ≥12 consecutive months of amenorrhea without other causes), and have not undergone sterilization (bilateral oophorectomy and/or hysterectomy).
- Highly effective contraceptive methods include bilateral tubal ligation, male sterilization, ovulation-suppressing hormonal contraceptives, hormonal intrauterine devices (IUDs), and copper IUDs.
- The reliability of sexual abstinence must be evaluated in relation to the duration of the clinical trial and the participant's lifestyle. Periodic abstinence (e.g., calendar method, ovulation method, basal body temperature method, post-ovulation method) and withdrawal are not acceptable methods of contraception.
- Male participants must agree to remain abstinent (avoid heterosexual intercourse) or use effective contraception and must agree not to donate sperm, as defined below:
- If the female partner is of childbearing potential, male participants must remain abstinent or use condoms plus an additional contraceptive method with a failure rate <1% per year during treatment and for at least 6 months after the last dose, and must not donate sperm during this period.
- If the female partner is pregnant, male participants must remain abstinent or use condoms during treatment and for at least 6 months after the last dose to avoid fetal exposure.
- -The reliability of sexual abstinence must be evaluated relative to the study duration and participant's lifestyle. Periodic abstinence and withdrawal are not acceptable methods.
Who cannot join
- Patients meeting any of the following criteria will be excluded from the study:
- Prior exposure to any immunotherapy.
- ECOG performance status >1.
- Evidence of distant metastasis or intrathoracic metastatic disease.
- Presence of actionable driver gene alterations with available targeted therapies, including but not limited to EGFR mutations, ALK fusions, ROS1 fusions, RET, NTRK, BRAF V600E mutations, or MET exon 14 skipping mutations.
- Pregnant women (positive pregnancy test prior to treatment) or breastfeeding women.
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- Known hypersensitivity or intolerance to recombinant humanized PD-1 monoclonal antibodies or any of their components (or excipients).
- Major surgery (excluding biopsy) within 4 weeks prior to the first dose of study treatment, or incomplete wound healing from prior surgery.
- Clinically significant cardiovascular or cerebrovascular disease, including but not limited to:
- Acute myocardial infarction within 6 months prior to enrollment
- Severe or unstable angina
- Cerebrovascular accident or transient ischemic attack
- Congestive heart failure (New York Heart Association class ≥II)
- Arrhythmias requiring antiarrhythmic treatment (except beta-blockers or digoxin)
- QTc interval >480 ms on repeated ECG measurements
- Hepatic or renal insufficiency, including conditions such as jaundice, ascites, and/or:
- Total bilirubin >3 × ULN
- Urinary protein >3.5 g/24 hours or renal failure requiring hemodialysis or peritoneal dialysis
- Urinalysis showing proteinuria ≥++ or confirmed 24-hour urinary protein >1.0 g
- Persistent active infection of grade >2 according to CTCAE version 5.0.
- Active autoimmune disease or history of autoimmune disease within the past 2 years, or known/suspected autoimmune disease that may affect vital organ function or require systemic immunosuppressive therapy, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- Allowed conditions include type I diabetes mellitus, hypothyroidism requiring hormone replacement only, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia), or conditions not expected to recur without external triggers.
- Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic immunosuppressive treatment.
- Prior or planned solid organ transplantation or allogeneic bone marrow transplantation.
- Active tuberculosis (Mycobacterium tuberculosis) or other active infections.
- Known history of human immunodeficiency virus (HIV) infection.
- Severe non-healing wounds, ulcers, or fractures.
- History of substance abuse, or any medical, psychological, or social condition that may interfere with study participation, compromise compliance, or pose a safety risk.
- Unresolved toxicities > grade 1 from any prior therapy or procedure (CTCAE version 5.0), except for alopecia, anemia, or hypothyroidism.
- Objective evidence of severe pulmonary dysfunction, including history of severe pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, or drug-related pneumonitis.
- Concomitant malignancies or history of other malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast or cervix, treated superficial bladder cancer, or prostate adenocarcinoma treated surgically with prostate-specific antigen (PSA) within normal limits.
- Any condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
- Concurrent participation in another clinical study.
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
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
binhe Tian, +8617782646786, 17782646786@163.com
Hanping Wang, MD, PhD
About this study
Official title: An Exploratory Study of QL1706 in Combination With Chemotherapy for the Perioperative Treatment of Non-Small Cell Lung Cancer
This is a single-center, open-label, single-arm phase II exploratory study evaluating a perioperative regimen of iparomlimab and tuvonralimab (QL1706; a bispecific PD-1/CTLA-4 antibody) combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage IIB-IIIB non-small cell lung cancer (NSCLC) without actionable driver alterations. Approximately 30 eligible participants will receive three 21-day cycles of neoadjuvant QL1706 plus chemotherapy, followed by surgical resection if feasible. After surgery, participants will be followed regularly to assess pathologic response, recurrence, survival outcomes, and safety, including immune-related adverse events. The primary efficacy endpoint is major pathologic response (MPR), defined as ≤10% residual viable tumor in the resected specimen. Secondary endpoints include event-free survival, overall survival, objective response rate, disease control rate, and R0 resection rate. Exploratory analyses will evaluate changes in the tumor immune microenvironment and peripheral immune profiles using tumor tissue and blood samples, including T-cell and B-cell receptor repertoire analyses and multi-omics profiling, with the goal of developing models to predict treatment benefit and immune-related toxicity risk.
Read the detailed description
Patients with stage IIB-IIIB NSCLC have a substantial risk of recurrence after surgery, and perioperative systemic therapy is used to improve long-term outcomes. Immune checkpoint blockade combined with chemotherapy has improved pathologic response rates in resectable NSCLC; however, a proportion of patients-especially those with low PD-L1 expression-may derive limited benefit from single-pathway blockade. QL1706 is a bispecific antibody targeting PD-1 and CTLA-4 intended to enhance antitumor immunity through dual checkpoint inhibition. This study explores the feasibility, pathologic response, and longer-term clinical outcomes of adding perioperative QL1706 to standard platinum-based chemotherapy in a resectable/potentially resectable population.
All participants will receive three cycles of neoadjuvant QL1706 plus chemotherapy every 21 days, followed by radiographic assessment and surgical evaluation. Safety will be monitored throughout treatment and for 28 days after the last dose, with special attention to immune-related adverse events. After surgery, participants will be followed for recurrence and survival. Tumor tissue and peripheral blood will be collected at protocol-defined timepoints for exploratory biomarker studies (e.g., PD-L1 and immune cell profiling, TCR/BCR repertoire sequencing, transcriptomic/proteomic analyses), aiming to characterize immune changes associated with response, resistance, and immune-related toxicities and to develop predictive models for benefit and risk.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- QL1706 plus chemotherapy
- Keywords
- Neoadjuvant immunotherapy, QL1706, Immune checkpoint inhibitor, Non-Small Cell Lung Cancer
- 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 plus chemotherapyDrug
QL1706, a bispecific anti-PD-1/CTLA-4 monoclonal antibody, is administered intravenously in combination with standard platinum-based chemotherapy as neoadjuvant treatment prior to surgery. Treatment is given for a planned number of cycles before surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 Combination Therapy Arm | Experimental | Not described Receives: Drug: QL1706 plus chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with major pathological response (MPR)
MPR is defined as ≤10% residual viable tumor cells in the resected primary tumor specimen (and resected lymph nodes if applicable) assessed by histopathologic review after neoadjuvant therapy.
Measured: Perioperative/Periprocedural (Day of surgery)
Secondary outcomes (3)
Percentage of participants with pathological complete response (pCR)
pCR is defined as 0% residual viable tumor cells in the resected primary tumor specimen (and resected lymph nodes if applicable) assessed by histopathologic review at definitive surgery.
Measured: Perioperative/Periprocedural (Day of surgery)
Safety and Tolerability
Adverse events will be graded according to CTCAE v5.0 and summarized as the number and percentage of participants with any-grade TEAEs, grade ≥3 TEAEs, serious adverse events, and TEAEs leading to treatment discontinuation.
Measured: From first dose (Day 1) through 30 days after surgery
Percentage of participants with R0 resection
R0 resection is defined as microscopically margin-negative resection (no tumor at the inked resection margin) on final surgical pathology after completion of neoadjuvant therapy.
Measured: Perioperative/Periprocedural (Day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start3 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanping Wang, MD, PhD, Principal investigator, Department of Pulmonary and Critical Care MedICIsne, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452003
- Sponsor's protocol ID
- PUMCH-K8601
- Other IDs
- L248072
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, plans for sharing individual participant data (IPD) have not been finalized. Data sharing will be considered after study completion, data anonymization, and in accordance with institutional policies and ethical requirements. Requests for access may be reviewed by the study investigators on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of QL1706 in Combination With Chemotherapy for the Perioperative Treatment of Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07452003
- Acronym / sponsor ID
- PUMCH-K8601
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Neoadjuvant immunotherapy, QL1706, Immune checkpoint inhibitor, Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 5 Mar 2026 (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.
This is a single-center, open-label, single-arm phase II exploratory study evaluating a perioperative regimen of iparomlimab and tuvonralimab (QL1706; a bispecific PD-1/CTLA-4 antibody) combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage IIB-IIIB non-small cell lung cancer (NSCLC) without actionable driver alterations. Approximately 30 eligible participants will receive three 21-day cycles of neoadjuvant QL1706 plus chemotherapy, followed by surgical resection if feasible. After surgery, participants will be followed regularly to assess pathologic response, recurrence, survival outcomes, and safety, including immune-related adverse events. The primary efficacy endpoint is major pathologic response (MPR), defined as ≤10% residual viable tumor in the resected specimen. Secondary endpoints include event-free survival, overall survival, objective response rate, disease control rate, and R0 resection rate. Exploratory analyses will evaluate changes in the tumor immune microenvironment and peripheral immune profiles using tumor tissue and blood samples, including T-cell and B-cell receptor repertoire analyses and multi-omics profiling, with the goal of developing models to predict treatment benefit and immune-related toxicity risk.
Detailed description
Patients with stage IIB-IIIB NSCLC have a substantial risk of recurrence after surgery, and perioperative systemic therapy is used to improve long-term outcomes. Immune checkpoint blockade combined with chemotherapy has improved pathologic response rates in resectable NSCLC; however, a proportion of patients-especially those with low PD-L1 expression-may derive limited benefit from single-pathway blockade. QL1706 is a bispecific antibody targeting PD-1 and CTLA-4 intended to enhance antitumor immunity through dual checkpoint inhibition. This study explores the feasibility, pathologic response, and longer-term clinical outcomes of adding perioperative QL1706 to standard platinum-based chemotherapy in a resectable/potentially resectable population.
All participants will receive three cycles of neoadjuvant QL1706 plus chemotherapy every 21 days, followed by radiographic assessment and surgical evaluation. Safety will be monitored throughout treatment and for 28 days after the last dose, with special attention to immune-related adverse events. After surgery, participants will be followed for recurrence and survival. Tumor tissue and peripheral blood will be collected at protocol-defined timepoints for exploratory biomarker studies (e.g., PD-L1 and immune cell profiling, TCR/BCR repertoire sequencing, transcriptomic/proteomic analyses), aiming to characterize immune changes associated with response, resistance, and immune-related toxicities and to develop predictive models for benefit and risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 Combination Therapy Arm | Experimental | Drug: QL1706 plus chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Patients are eligible for enrollment in this study only if they meet all of the following inclusion criteria and none of the exclusion criteria:
- The subject voluntarily participates in the study, provides written informed consent, demonstrates good compliance, and is willing to cooperate with study procedures and follow-up.
- Age ≥18 years at the time of signing the informed consent form; sex not restricted.
- Histologically confirmed non-small cell lung cancer (NSCLC).
- At least one measurable lesion according to RECIST version 1.1 (measurable lesion defined as a longest diameter ≥10 mm on spiral CT scan, or lymph node with a short axis ≥15 mm).
Key exclusion criteria (33 listed)
- Prior exposure to any immunotherapy.
- ECOG performance status >1.
- Evidence of distant metastasis or intrathoracic metastatic disease.
- Presence of actionable driver gene alterations with available targeted therapies, including but not limited to EGFR mutations, ALK fusions, ROS1 fusions, RET, NTRK, BRAF V600E mutations, or MET exon 14 skipping mutations.
- Pregnant women (positive pregnancy test prior to treatment) or breastfeeding women.
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 plus chemotherapyQL1706, a bispecific anti-PD-1/CTLA-4 monoclonal antibody, is administered intravenously in combination with standard platinum-based chemotherapy as neoadjuvant treatment prior to surgery. Treatment is given for a planned number of cycles before surgical resection. | Drug | QL1706 Combination Therapy Arm |
Primary outcome
Percentage of participants with major pathological response (MPR)
Time frame: Perioperative/Periprocedural (Day of surgery)
MPR is defined as ≤10% residual viable tumor cells in the resected primary tumor specimen (and resected lymph nodes if applicable) assessed by histopathologic review after neoadjuvant therapy.
3 secondary outcomes
Percentage of participants with pathological complete response (pCR)
Time frame: Perioperative/Periprocedural (Day of surgery)
Safety and Tolerability
Time frame: From first dose (Day 1) through 30 days after surgery
Percentage of participants with R0 resection
Time frame: Perioperative/Periprocedural (Day of surgery)
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided. At this time, plans for sharing individual participant data (IPD) have not been finalized. Data sharing will be considered after study completion, data anonymization, and in accordance with institutional policies and ethical requirements. Requests for access may be reviewed by the study investigators on a case-by-case basis.
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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.
Hanping Wang, MD, PhD principal investigator
Department of Pulmonary and Critical Care MedICIsne, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QL1706 plus chemotherapy in people with Non-Small Cell Lung Cancer, run by Peking Union Medical College Hospital 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 30 inclusion and 33 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 5 Mar 2026. 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.
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 binhe Tian (+8617782646786, 17782646786@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with major pathological response (MPR) (time frame: Perioperative/Periprocedural (Day of surgery)). 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 5 Mar 2026.