Non Small Cell Lung CancerPhase 2NCT07271602
A Phase 2 Randomized, Controlled Trial of QL1706 Plus Chemotherapy and Quad Shot for Driver Gene-negative Advanced Non-small Cell Lung Cancer.
A Phase 2 study testing Quad shot, Chemotherapy and Immune Checkpoint Inhibitors in people with Non Small Cell Lung Cancer and Immunotherapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
Chemotherapy combined with immunotherapy has become the first-line standard treatment regimen for metastatic non-small cell lung cancer (NSCLC). QL1706 is an antibody that can simultaneously block the CTLA-4 and PD-1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Immunotherapy, Radiotherapy
- What is being tested?
- Quad shot, Chemotherapy and Immune Checkpoint Inhibitors
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 31 Dec 2028
- Phase
- Phase 2
- 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
- Confirmed age: 18-75 years;
- Histologically or cytologically diagnosed as lung squamous cell carcinoma or lung adenocarcinoma;
- Staged as stage IV (T1-4NxM1) according to the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) Cancer Staging System (9th edition), with at least 2 evaluable lesions, including one distant metastatic lesion;
- Driver gene-negative;
- ECOG performance status: 0-1;
- Normal bone marrow function: white blood cell count > 4×10⁹/L, hemoglobin concentration > 90 g/L, platelet count > 100×10⁹/L;
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- Normal liver and kidney function: total bilirubin ≤ 1.5×upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5×ULN; alkaline phosphatase (ALP) ≤ 2.5×ULN; creatinine clearance ≥ 60 mL/min;
- Normal results of thyroid function, amylase, lipase, pituitary function, inflammatory/infectious markers, myocardial enzymes, and electrocardiogram (ECG). For patients aged > 50 years with a smoking history, normal pulmonary function test results are required. For patients with abnormal ECG or a history of cardiovascular disease (that does not meet the exclusion criteria listed in item 7), additional myocardial function tests and echocardiography are required, with normal results;
- Patients have signed the informed consent form and are willing and able to comply with follow-up, treatment, laboratory tests, and other study requirements as specified in the study schedule;
- Female subjects of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regularly used contraceptives as prescribed by a physician) from screening until 1 year after treatment.
Who cannot join
- Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) DNA quantitation > 1×10³ copies/mL, or positive for anti-hepatitis C virus (HCV) antibody;
- Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS);
- Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year, regardless of treatment status, should be excluded. Patients with a history of active tuberculosis more than 1 year ago should be excluded, except those with confirmed regular anti-tuberculosis treatment in the past;
- Active, known, or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary disorders, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators). Exceptions include type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
- A history of interstitial lung disease or pneumonia within the past year requiring oral or intravenous steroid treatment;
- Chronic systemic glucocorticoid therapy (dose equivalent to or exceeding 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects receiving inhaled or topical corticosteroids are eligible;
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- Uncontrolled heart disease, such as: 1) Heart failure with NYHA class ≥ 2; 2) Unstable angina pectoris; 3) History of myocardial infarction within the past year; 4) Supraventricular or ventricular arrhythmias requiring treatment or intervention;
- Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing age);
- Previous or current malignant tumors other than adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma;
- Hypersensitivity to macromolecular protein preparations or any component of QL1706;
- Active infection within 1 week requiring systemic treatment;
- Receipt of live vaccines within 30 days prior to the first course of immunotherapy;
- History of organ transplantation;
- Other conditions assessed by investigators that may endanger patient safety or compliance, such as severe diseases requiring prompt treatment (including mental illnesses), significantly abnormal test results, or other psychological, family, or social high-risk factors.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Iparomlimab and Tuvonralimab (QL1706) Combined Chemotherapy and Quad Shot Radiotherapy in First-line Treatment of Driver Gene-negative Advanced Non-small Cell Lung Cancer: a Randomized, Controlled, Phase 2, Open-label Trial.
Chemotherapy combined with immunotherapy has become the first-line standard treatment regimen for metastatic non-small cell lung cancer (NSCLC). QL1706 is an antibody that can simultaneously block the CTLA-4 and PD-1. In a phase II clinical study, when QL1706 was combined with chemotherapy for first-line treatment of metastatic NSCLC, the median progression-free survival (mPFS) was 6.8 months and the objective response rate (ORR) was 45% at a median follow-up time of 12.6 months (range, 0.4-15.2 months).
Radiotherapy is one of the commonly used local treatment modalities for tumors, which has a synergistic effect with immunotherapy, can enhance the response to immunotherapy, and trigger the abscopal effect. Quad shot radiotherapy is a periodic pulsed hypofractionated radiotherapy, with a specific mode as follows: 2 fractions per day, with an interval of more than 6 hours between the two fractions, for 2 consecutive days, with a total dose of 14-14.8 Gy. This regimen can be repeated every 3-4 weeks for a total of 3 cycles, with a total treatment dose of approximately 44-48 Gy, and it can be used for palliative treatment of various advanced tumors.
This project intends to explore whether the addition of Quad shot radiotherapy to QL1706 combined with chemotherapy can improve local and systemic tumor control rates, prolong patients' PFS, and evaluate the safety of the combined therapy in treatment-naive patients with metastatic NSCLC.
- Conditions
- Non Small Cell Lung Cancer, Immunotherapy, Radiotherapy, Chemotherapy
- Being tested
- Quad shot, Chemotherapy, Immune Checkpoint Inhibitors
- 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.
Quad shotRadiation
Intensity-modulated radiotherapy (IMRT) technique is adopted, and only partial lesions (as determined by the investigator) receive Quad shot radiotherapy. Only the gross tumor volume (GTV) is irradiated, with no prophylactic irradiation of lymph nodes. The irradiation dose for the planning gross tumor volume (PGTV) is 14.8 Gy in 4 fractions, administered twice daily (bid), with an interval of more than 6 hours between each irradiation. The treatment is repeated every 3 weeks for a total of 3 cycles.
ChemotherapyDrug
For patients with lung squamous cell carcinoma, TC regimen chemotherapy combined with QL1706 is administered on days 1, 22, 43, and 64, respectively. The specific TC chemotherapy regimen is as follows: nab-paclitaxel 260 mg/m², intravenous infusion; carboplatin at an AUC of 5, with the total dose (mg) calculated as AUC × (GFR + 25), where GFR refers to glomerular filtration rate, administered via intravenous infusion.
For patients with lung adenocarcinoma, PC regimen chemotherapy combined with QL1706 is administered on days 1, 22, 43, and 64, respectively. The specific PC chemotherapy regimen is as follows: pemetrexed 500 mg/m², intravenous infusion; carboplatin at an AUC of 5, with the total dose (mg) calculated as AUC × (GFR + 25), where GFR refers to glomerular filtration rate, administered via intravenous infusion.
Immune Checkpoint InhibitorsDrug
The specific treatment regimen for QL1706 is as follows: QL1706 (5 mg/kg) via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| QL1706, chemotherapy, Quad shot radiotherapy | Experimental | QL1706 is combined with chemotherapy for 4 cycles. Starting from Cycle 1, concurrent Quad shot radiotherapy is administered (for a maximum of 3 cycles), followed by entry into the QL1706 maintenance treatment phase. Receives: Radiation: Quad shot; Drug: Chemotherapy; Drug: Immune Checkpoint Inhibitors |
| Chemotherapy, QL1706 | Placebo comparator | QL1706 is combined with chemotherapy for a total of 4 cycles, with one cycle administered every 21 days; subsequent treatment proceeds to the QL1706 maintenance therapy phase. Receives: Drug: Chemotherapy; Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start30 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271602
- Sponsor's protocol ID
- UNION-LUNG-001
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iparomlimab and Tuvonralimab (QL1706) Combined Chemotherapy and Quad Shot Radiotherapy in First-line Treatment of Driver Gene-negative Advanced Non-small Cell Lung Cancer: a Randomized, Controlled, Phase 2, Open-label Trial.
- ClinicalTrials.gov ID
- NCT07271602
- Acronym / sponsor ID
- UNION-LUNG-001
- Conditions
- Non Small Cell Lung Cancer, Immunotherapy, Radiotherapy, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Dec 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.
Chemotherapy combined with immunotherapy has become the first-line standard treatment regimen for metastatic non-small cell lung cancer (NSCLC). QL1706 is an antibody that can simultaneously block the CTLA-4 and PD-1. In a phase II clinical study, when QL1706 was combined with chemotherapy for first-line treatment of metastatic NSCLC, the median progression-free survival (mPFS) was 6.8 months and the objective response rate (ORR) was 45% at a median follow-up time of 12.6 months (range, 0.4-15.2 months).
Radiotherapy is one of the commonly used local treatment modalities for tumors, which has a synergistic effect with immunotherapy, can enhance the response to immunotherapy, and trigger the abscopal effect. Quad shot radiotherapy is a periodic pulsed hypofractionated radiotherapy, with a specific mode as follows: 2 fractions per day, with an interval of more than 6 hours between the two fractions, for 2 consecutive days, with a total dose of 14-14.8 Gy. This regimen can be repeated every 3-4 weeks for a total of 3 cycles, with a total treatment dose of approximately 44-48 Gy, and it can be used for palliative treatment of various advanced tumors.
This project intends to explore whether the addition of Quad shot radiotherapy to QL1706 combined with chemotherapy can improve local and systemic tumor control rates, prolong patients' PFS, and evaluate the safety of the combined therapy in treatment-naive patients with metastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706, chemotherapy, Quad shot radiotherapy | Experimental | Radiation: Quad shot, Drug: Chemotherapy, Drug: Immune Checkpoint InhibitorsQL1706 is combined with chemotherapy for 4 cycles. Starting from Cycle 1, concurrent Quad shot radiotherapy is administered (for a maximum of 3 cycles), followed by entry into the QL1706 maintenance treatment phase. |
| Chemotherapy, QL1706 | Placebo comparator | Drug: Chemotherapy, Drug: Immune Checkpoint InhibitorsQL1706 is combined with chemotherapy for a total of 4 cycles, with one cycle administered every 21 days; subsequent treatment proceeds to the QL1706 maintenance therapy phase. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed age: 18-75 years;
- Histologically or cytologically diagnosed as lung squamous cell carcinoma or lung adenocarcinoma;
- Staged as stage IV (T1-4NxM1) according to the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) Cancer Staging System (9th edition), with at least 2 evaluable lesions, including one distant metastatic lesion;
- Driver gene-negative;
- ECOG performance status: 0-1;
Key exclusion criteria (14 listed)
- Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) DNA quantitation > 1×10³ copies/mL, or positive for anti-hepatitis C virus (HCV) antibody;
- Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS);
- Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year, regardless of treatment status, should be excluded. Patients with a history of active tuberculosis more than 1 year ago should be excluded, except those with confirmed regular anti-tuberculosis treatment in the past;
- Active, known, or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary disorders, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators). Exceptions include type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
- A history of interstitial lung disease or pneumonia within the past year requiring oral or intravenous steroid treatment;
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 |
|---|---|---|
| Quad shotIntensity-modulated radiotherapy (IMRT) technique is adopted, and only partial lesions (as determined by the investigator) receive Quad shot radiotherapy. Only the gross tumor volume (GTV) is irradiated, with no prophylactic irradiation of lymph nodes. The irradiation dose for the planning gross tumor volume (PGTV) is 14.8 Gy in 4 fractions, administered twice daily (bid), with an interval of more than 6 hours between each irradiation. The treatment is repeated every 3 weeks for a total of 3 cycles. | Radiation | QL1706, chemotherapy, Quad shot radiotherapy |
| ChemotherapyFor patients with lung squamous cell carcinoma, TC regimen chemotherapy combined with QL1706 is administered on days 1, 22, 43, and 64, respectively. The specific TC chemotherapy regimen is as follows: nab-paclitaxel 260 mg/m², intravenous infusion; carboplatin at an AUC of 5, with the total dose (mg) calculated as AUC × (GFR + 25), where GFR refers to glomerular filtration rate, administered via intravenous infusion. For patients with lung adenocarcinoma, PC regimen chemotherapy combined with QL1706 is administered on days 1, 22, 43, and 64, respectively. The specific PC chemotherapy regimen is as follows: pemetrexed 500 mg/m², intravenous infusion; carboplatin at an AUC of 5, with the total dose (mg) calculated as AUC × (GFR + 25), where GFR refers to glomerular filtration rate, administered via intravenous infusion. | Drug | Chemotherapy, QL1706, QL1706, chemotherapy, Quad shot radiotherapy |
| Immune Checkpoint InhibitorsThe specific treatment regimen for QL1706 is as follows: QL1706 (5 mg/kg) via intravenous infusion. | Drug | Chemotherapy, QL1706, QL1706, chemotherapy, Quad shot radiotherapy |
Primary outcome
Objective Response Rate
Time frame: 1 year
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 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quad shot, Chemotherapy and Immune Checkpoint Inhibitors in people with Non Small Cell Lung Cancer and Immunotherapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 10 inclusion and 14 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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Kunyu Yang (027 83262731, yangkunyu@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 1 year). 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 9 Dec 2025.