Non-small Cell Lung Cancer (NSCLC)Phase 2NCT06897046
Perioperative Study of Iparomlimab and Tuvonralimab in Resectable NSCLC
A Phase 2 study testing QL1706 and QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ Pemetrexed in people with Non-small Cell Lung Cancer (NSCLC) and II-IIIB, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This project intends to study the efficacy and safety of Iparomlimab and Tuvonralimab with or without chemotherapyin the perioperative treatment of NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), II-IIIB
- What is being tested?
- QL1706 and QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 25 May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Voluntary Participation，willing to participate in this study and has signed the Informed Consent Form (ICF).
- 2. Age, ≥18 years old, both male and female. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 4. Histologically or cytologically confirmed, treatment-naïve Stage II-IIIB (N2 only) non-small cell lung cancer (NSCLC) according to the 8th edition of the American Joint Committee on Cancer (AJCC). Only patients judged as T4 based on tumor size are allowed to be enrolled; other T4 conditions (e.g., invasion of the diaphragm, mediastinal involvement) are not permitted.
- 5. The primary NSCLC is deemed resectable by multidisciplinary team (MDT) assessment, which must include a thoracic surgeon specializing in oncologic surgery.
- 6. Ability to provide surgical or biopsy tumor tissue for biomarker analysis (e.g., genetic sequencing, PD-L1 testing). The following must be provided before enrollment: Formalin-fixed paraffin-embedded (FFPE) tissue block from within the past 3 months, or 5-10 unstained tissue slides, or 2 core biopsy specimens, along with the relevant pathology report. Fine-needle aspiration specimens are not acceptable.
- 7. At least one measurable lesion according to RECIST v1.1 criteria, as determined by the investigator.
Who cannot join
- 1. Presence of confirmed EGFR or ALK positive mutations. 2. History of other malignancies within the past 5 years or concurrent malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
- 3. Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1 agents), other drugs targeting T-cell receptors (e.g., CTLA-4), immune checkpoint agonist antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40 antibodies), or anti-tumor immune cell therapy.
- 4. History of Allogeneic Hematopoietic Stem Cell Transplantation or Solid Organ Transplantation: (except for corneal transplantation).
- 5. Presence of congenital or acquired immunodeficiency (e.g., HIV infection). 6. History of severe allergic reactions to other monoclonal antibodies. 7. As determined by the investigator, any other factors that may affect study outcomes or lead to premature termination of the study, such as alcohol or drug abuse, other serious diseases (including psychiatric conditions) requiring concomitant treatment, significant laboratory abnormalities, or social or family factors that may impact patient safety.
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
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union
Beijing
Shugeng Gao, 0086-13681130082, gaoshugeng@vip.sina.com
gaoshugeng@vip.sina.com
About this study
This project intends to study the efficacy and safety of Iparomlimab and Tuvonralimab with or without chemotherapyin the perioperative treatment of NSCLC
- Conditions
- Non-small Cell Lung Cancer (NSCLC), II-IIIB
- Being tested
- QL1706, QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ Pemetrexed
- 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.
QL1706Drug
PD-1/CTLA-4
QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ PemetrexedDrug
PD-1/CTLA4 combined chemotherapy drugs
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab combined chemotherapy neoadjuvant | Experimental | Neoadjuvant: Squamous Non-Small Cell Lung Cancer, Iparomlimab and Tuvonralimab 5 mg/kg Q3W (Day 1) + Paclitaxel（Albumin-bound ） 130 mg/m² Q3W (Day 1, Day 8) + Carboplatin (AUC=5) Q3W (Day 1) ; Non-Squamous Non-Small Cell Lung Cancer :Iparomlimab and Tuvonralimab 5 mg/kg Q3W (Day 1) + Pemetrexed 500 mg/m² Q3W (Day 1) + Carboplatin (AUC=5) Q3W (Day 1) Postoperative adjuvant therapy: Iparomlimab and Tuvonralimab combined chemotherapy or Iparomlimab and Tuvonralimab monotherapy or Other adjuvant treatment options Receives: Drug: QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ Pemetrexed |
| Iparomlimab and Tuvonralimab Neoadjuvant | Experimental | Neoadjuvant: Prior to surgery, participants receive 2-4 cycles Iparomlimab and Tuvonralimab, 5 mg/kg Q3W (Day 1). Postoperative adjuvant therapy: Iparomlimab and Tuvonralimab combined chemotherapy or Iparomlimab and Tuvonralimab monotherapy or Other adjuvant treatment options Receives: Drug: QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells
Measured: 4 weeks after surgery
Secondary outcomes (4)
Major Pathological Response Rate (MPR)
The MPR is defined as the percentage of subjects who underwent lung cancer resection with ≤10% residual viable tumor cells in the postoperative tumor bed (regardless of the presence or absence of residual viable tumor cells in the lymph nodes).
Measured: 4 weeks after surgery
Objective Response Rate (ORR)
The proportion of subjects who received neoadjuvant therapy and had at least one post-baseline imaging assessment, achieving a best response of complete response (CR) or partial response (PR) on preoperative imaging. For subjects who did not undergo surgical resection, the results from the first planned post-baseline imaging assessment were used for evaluation; confirmation of the best response was not required
Measured: After completion of neoadjuvant therapy, before surgery
R0 Resection Rate
The percentage of subjects who underwent resection and achieved complete resection (R0) among all subjects who received lung cancer surgery.
Measured: 2 weeks after surgery
2-Year Event-Free Survival Rate (EFS)
Defined as the time from the date of first study treatment administration to the date of occurrence of any of the following events: disease progression or deterioration leading to inability to undergo surgery, attempted surgery but abandoned due to unresectable tumor or disease deterioration, postoperative disease progression or recurrence (RECIST 1.1), disease progression or recurrence without surgery, or death from any cause.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start30 Jul 2025
- Primary completion25 Feb 2027 (estimated)
- Study completion25 May 2027 (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 Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shugeng Gao, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesJie Wang, MD, Principal investigator, Shanxi Province Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897046
- Sponsor's protocol ID
- QL-NSCLC-QIBA-1001
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Study of Iparomlimab and Tuvonralimab in Resectable NSCLC
- ClinicalTrials.gov ID
- NCT06897046
- Acronym / sponsor ID
- QL-NSCLC-QIBA-1001
- Conditions
- Non-small Cell Lung Cancer (NSCLC), II-IIIB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 26 Mar 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.
This project intends to study the efficacy and safety of Iparomlimab and Tuvonralimab with or without chemotherapyin the perioperative treatment of NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab combined chemotherapy neoadjuvant | Experimental | Drug: QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ PemetrexedNeoadjuvant: Squamous Non-Small Cell Lung Cancer, Iparomlimab and Tuvonralimab 5 mg/kg Q3W (Day 1) + Paclitaxel（Albumin-bound ） 130 mg/m² Q3W (Day 1, Day 8) + Carboplatin (AUC=5) Q3W (Day 1) ; Non-Squamous Non-Small Cell Lung Cancer :Iparomlimab and Tuvonralimab 5 mg/kg Q3W (Day 1) + Pemetrexed 500 mg/m² Q3W (Day 1) + Carboplatin (AUC=5) Q3W (Day 1) Postoperative adjuvant therapy: Iparomlimab and Tuvonralimab combined chemotherapy or Iparomlimab and Tuvonralimab monotherapy or Other adjuvant treatment options |
| Iparomlimab and Tuvonralimab Neoadjuvant | Experimental | Drug: QL1706Neoadjuvant: Prior to surgery, participants receive 2-4 cycles Iparomlimab and Tuvonralimab, 5 mg/kg Q3W (Day 1). Postoperative adjuvant therapy: Iparomlimab and Tuvonralimab combined chemotherapy or Iparomlimab and Tuvonralimab monotherapy or Other adjuvant treatment options |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Voluntary Participation，willing to participate in this study and has signed the Informed Consent Form (ICF).
- 2. Age, ≥18 years old, both male and female. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 4. Histologically or cytologically confirmed, treatment-naïve Stage II-IIIB (N2 only) non-small cell lung cancer (NSCLC) according to the 8th edition of the American Joint Committee on Cancer (AJCC). Only patients judged as T4 based on tumor size are allowed to be enrolled; other T4 conditions (e.g., invasion of the diaphragm, mediastinal involvement) are not permitted.
- 5. The primary NSCLC is deemed resectable by multidisciplinary team (MDT) assessment, which must include a thoracic surgeon specializing in oncologic surgery.
- 6. Ability to provide surgical or biopsy tumor tissue for biomarker analysis (e.g., genetic sequencing, PD-L1 testing). The following must be provided before enrollment: Formalin-fixed paraffin-embedded (FFPE) tissue block from within the past 3 months, or 5-10 unstained tissue slides, or 2 core biopsy specimens, along with the relevant pathology report. Fine-needle aspiration specimens are not acceptable.
Key exclusion criteria (4 listed)
- 1. Presence of confirmed EGFR or ALK positive mutations. 2. History of other malignancies within the past 5 years or concurrent malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
- 3. Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1 agents), other drugs targeting T-cell receptors (e.g., CTLA-4), immune checkpoint agonist antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40 antibodies), or anti-tumor immune cell therapy.
- 4. History of Allogeneic Hematopoietic Stem Cell Transplantation or Solid Organ Transplantation: (except for corneal transplantation).
- 5. Presence of congenital or acquired immunodeficiency (e.g., HIV infection). 6. History of severe allergic reactions to other monoclonal antibodies. 7. As determined by the investigator, any other factors that may affect study outcomes or lead to premature termination of the study, such as alcohol or drug abuse, other serious diseases (including psychiatric conditions) requiring concomitant treatment, significant laboratory abnormalities, or social or family factors that may impact patient safety.
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 |
|---|---|---|
| QL1706PD-1/CTLA-4 | Drug | Iparomlimab and Tuvonralimab Neoadjuvant |
| QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ PemetrexedPD-1/CTLA4 combined chemotherapy drugs | Drug | Iparomlimab and Tuvonralimab combined chemotherapy neoadjuvant |
Primary outcome
Pathologic complete response (pCR)
Time frame: 4 weeks after surgery
pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells
4 secondary outcomes
Major Pathological Response Rate (MPR)
Time frame: 4 weeks after surgery
Objective Response Rate (ORR)
Time frame: After completion of neoadjuvant therapy, before surgery
R0 Resection Rate
Time frame: 2 weeks after surgery
2-Year Event-Free Survival Rate (EFS)
Time frame: up to 2 years
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 1 Aug 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.
Shugeng Gao, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jie Wang, MD principal investigator
Shanxi Province Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 and QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ Pemetrexed in people with Non-small Cell Lung Cancer (NSCLC) and II-IIIB, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 4 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 1 Aug 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 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 Shugeng Gao, MD (8610-87788177, gaoshugeng@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) (time frame: 4 weeks after 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 1 Aug 2025.