Locally Advanced Non-Small Cell Lung CancerPhase 2NCT06837948
Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC
A Phase 2 study testing PM8002, Sintilimab and Nab-paclitaxel in people with Locally Advanced Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non-Small Cell Lung Cancer
- What is being tested?
- PM8002, Sintilimab and Nab-paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 1 Dec 2031
- 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
- The patient shall sign the Informed Consent Form.
- Aged 18 ≥ years.
- Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-III confirmed by imageological examinations (CT, PET-CT or EBUS)，and have not previously received anti-tumor treatment.
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
- Life expectancy is at least 12 weeks.
- At least 1 measurable lesion according to RECIST 1.1.
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- Patients with good function of other main organs (liver, kidney, blood system, etc.)
- Patients with lung function can tolerate surgery;
- Without systematic metastasis (including M1a, M1b and M1c);
- Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
- Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).
Who cannot join
- Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements;
- Histological evidence of small cell components;
- Patients with other malignant tumors within five years prior to the start of this trial;
- Having received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, and experimental treatment, etc.;
- Concomitant unstable systemic diseases, including active infections, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), unstable angina, angina that started within the last 3 months, congestive heart failure (≥New York Heart Association [NYHA] Class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring drug treatment, liver, kidney, or metabolic diseases;
- Active, known, or suspected autoimmune diseases, or autoimmune paraneoplastic syndromes requiring systemic treatment;
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- Allergy to the trial drug;
- Currently diagnosed with interstitial lung disease;
- Concomitant HIV infection or active hepatitis;
- Pregnant or lactating women;
- Patients with neurological or psychiatric disorders who are unable to cooperate;
- Concurrently participating in another therapeutic clinical study;
- Other situations deemed unsuitable for enrollment by the investigator.
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
Shanghai Pulmonary Hospital
Shanghai, 200433
Peng Zhang, PhD, zhangpeng1121@tongji.edu.cn
About this study
Official title: Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced Non-Small Cell Lung Cancer: A Multicenter, Randomized Controlled Clinical Trial
Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Blocking vascular endothelial growth factor (VEGF) not only inhibits the proliferation of vascular endothelial cells and the formation of new blood vessels but also improves the tumor microenvironment and enhances the infiltration of cytotoxic T lymphocytes within it. Simultaneously targeting the VEGF and PD-L1 pathways can create a synergistic anti-cancer effect. PM8002 injection is a bispecific antibody drug that targets both PD-L1 and VEGF, functioning as a dual-action agent that combines immune suppression and anti-angiogenesis. In patients with locally advanced stage II-III NSCLC, neoadjuvant therapy that concurrently targets PD-L1/VEGF in combination with chemotherapy can improve pathological response rates, provided that the safety of the drug combination is maintained. This approach offers additional benefits to patients, prolongs event-free survival (EFS), and improves prognosis.
- Being tested
- PM8002, Sintilimab, Nab-paclitaxel, Carboplatin, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM8002Drug
Specified dose on specified days.
SintilimabDrug
Specified dose on specified days.
Nab-paclitaxelDrug
Specified dose on specified days.
CarboplatinDrug
Specified dose on specified days.
SurgeryProcedure or surgery
Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.
| Study group | Role | What they receive |
|---|---|---|
| Exploratory arm | Experimental | In this arm, 20 patients with locally advanced Non-small cell lung cancer will receive 4 circles of neoadjuvant PM8002 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. Receives: Drug: PM8002; Drug: Nab-paclitaxel; Drug: Carboplatin; Procedure: Surgery |
| PM8002 arm | Experimental | Patients with locally advanced Non-small cell lung cancer will be randomized into this arm (70 patients) and receive 4 circles of neoadjuvant PM8002 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. Receives: Drug: PM8002; Drug: Nab-paclitaxel; Drug: Carboplatin; Procedure: Surgery |
| Sintilimab arm | Active comparator | Patients with locally advanced Non-small cell lung cancer will be randomized into this arm (70 patients) and receive 4 circles of neoadjuvant Sintilimab combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. Receives: Drug: Sintilimab; Drug: Nab-paclitaxel; Drug: Carboplatin; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (PCR) rate
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
Measured: Up to 30 months
Secondary outcomes (7)
Event-free survival (EFS)
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: Up to 60 months
Overall survival (OS)
It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Measured: Up to 60 months
Major pathologic response (MPR) rate
MPR rate is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants.
Measured: Up to 30 months
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Measured: Up to 30 months
R0 resection rate
R0 resection rate is defined as the proportion of participants who have achieved R0 resection (complete resection with no residual tumor cell in the resection margin) in all participants.
Measured: Up to 30 months
Treatment-related adverse event (TRAE)
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Measured: Up to 30 months
Health related quality of life (HRQol) composite
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start18 Feb 2025 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Peng Zhang, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837948
- Sponsor's protocol ID
- LungMate-026
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced Non-Small Cell Lung Cancer: A Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06837948
- Acronym / sponsor ID
- LungMate-026
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 18 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 20 Feb 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.
Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Blocking vascular endothelial growth factor (VEGF) not only inhibits the proliferation of vascular endothelial cells and the formation of new blood vessels but also improves the tumor microenvironment and enhances the infiltration of cytotoxic T lymphocytes within it. Simultaneously targeting the VEGF and PD-L1 pathways can create a synergistic anti-cancer effect. PM8002 injection is a bispecific antibody drug that targets both PD-L1 and VEGF, functioning as a dual-action agent that combines immune suppression and anti-angiogenesis. In patients with locally advanced stage II-III NSCLC, neoadjuvant therapy that concurrently targets PD-L1/VEGF in combination with chemotherapy can improve pathological response rates, provided that the safety of the drug combination is maintained. This approach offers additional benefits to patients, prolongs event-free survival (EFS), and improves prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exploratory arm | Experimental | Drug: PM8002, Drug: Nab-paclitaxel, Drug: Carboplatin, Procedure: SurgeryIn this arm, 20 patients with locally advanced Non-small cell lung cancer will receive 4 circles of neoadjuvant PM8002 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. |
| PM8002 arm | Experimental | Drug: PM8002, Drug: Nab-paclitaxel, Drug: Carboplatin, Procedure: SurgeryPatients with locally advanced Non-small cell lung cancer will be randomized into this arm (70 patients) and receive 4 circles of neoadjuvant PM8002 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. |
| Sintilimab arm | Active comparator | Drug: Sintilimab, Drug: Nab-paclitaxel, Drug: Carboplatin, Procedure: SurgeryPatients with locally advanced Non-small cell lung cancer will be randomized into this arm (70 patients) and receive 4 circles of neoadjuvant Sintilimab combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient shall sign the Informed Consent Form.
- Aged 18 ≥ years.
- Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-III confirmed by imageological examinations (CT, PET-CT or EBUS)，and have not previously received anti-tumor treatment.
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
- Life expectancy is at least 12 weeks.
Key exclusion criteria (13 listed)
- Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements;
- Histological evidence of small cell components;
- Patients with other malignant tumors within five years prior to the start of this trial;
- Having received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, and experimental treatment, etc.;
- Concomitant unstable systemic diseases, including active infections, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), unstable angina, angina that started within the last 3 months, congestive heart failure (≥New York Heart Association [NYHA] Class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring drug treatment, liver, kidney, or metabolic diseases;
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 |
|---|---|---|
| PM8002Specified dose on specified days. | Drug | Exploratory arm, PM8002 arm |
| SintilimabSpecified dose on specified days. | Drug | Sintilimab arm |
| Nab-paclitaxelSpecified dose on specified days. | Drug | Exploratory arm, PM8002 arm, Sintilimab arm |
| CarboplatinSpecified dose on specified days. | Drug | Exploratory arm, PM8002 arm, Sintilimab arm |
| SurgeryPatients with resectable tumor after neoadjuvant therapy will be treated with surgery. | Procedure or surgery | Exploratory arm, PM8002 arm, Sintilimab arm |
Primary outcome
Pathologic complete response (PCR) rate
Time frame: Up to 30 months
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
7 secondary outcomes
Event-free survival (EFS)
Time frame: Up to 60 months
Overall survival (OS)
Time frame: Up to 60 months
Major pathologic response (MPR) rate
Time frame: Up to 30 months
Objective response rate (ORR)
Time frame: Up to 30 months
R0 resection rate
Time frame: Up to 30 months
Treatment-related adverse event (TRAE)
Time frame: Up to 30 months
Health related quality of life (HRQol) composite
Time frame: Up to 5 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 20 Feb 2025.
- Individual participant dataSharing planned: Undecided. The researchers will consider whether IPD is available to other researchers only after the paper is published.
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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.
Peng Zhang, PhD principal investigator
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 2 study testing PM8002, Sintilimab and Nab-paclitaxel in people with Locally Advanced Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 11 inclusion and 13 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 20 Feb 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 Peng Zhang, PhD (02165115006, zhangpeng1121@tongji.edu.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) rate (time frame: Up to 30 months). 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 20 Feb 2025.