Lung Cancer (NSCLC)Phase 2NCT06987734
Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients
A Phase 2 study testing Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab in people with Lung Cancer (NSCLC), run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This is a single arm, open-label exploratory study conducted in resectable stage II-IIIA NSCLC without EGFR/ALK mutations, aiming to investigate feasibility, safety and efficacy of Sugemalimab in perioperative contexts. Twenty-five resectable stage II-IIIA patients are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2025to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patients have voluntarily to join the study and give written informed consent for the study.
- Histologically documented, stage II-IIIA Non-Small Cell Lung Cancer (according to version 9th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated.
- Tumor should be considered resectable before study entry by a multidisciplinary team.
- ECOG Performance Status of 0 or 1
- At least 1 unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
Show all 17Show fewer
- Able to comply with study and follow-up procedures
- Major organ function For regular test results（no blood transfusion within 14 days）：
- Hemoglobin（HB）≥90g/L；
- Absolute neutrophils count（ANC）≥1.5×109/L；
- Blood platelets（PLT）≥100×109/L
- Biochemical tests results defined as follows:
- Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ；
- Alanine aminotransferase (ALT) and aspartate aminotransgerase AST≤2.5*ULN,
- Creatinine（Cr）≤1.5*ULN or Creatinine Clearance rate (CCr)≥60 ml/min; Coagulation test: INR/APTT within normal limits Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value (50%).
- The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters
- Subjects must provide fresh tissues or formalin-fixed tumor tissue samples at or the diagnosis NSCLC for mIF.
Who cannot join
- 1) All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
- 2) Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
- 3) Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy 4) Severe acute or chronic infections, including: hepatits B, hepatits C, HIV etc 5) Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
- 6) Histologically confirmed adenosquamous carcinoma 7) Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins 8) Subjects have interstitial lung disease (ILD), or a history of ILD that required corticosteroid treatment.
- 9) Women in pregnancy or lactation. 10) Patients who are allergic to any of the agent or any ingredient
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
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai, Shanghai Municipality, 200433
shengxiang ren Ren, Pro., 02165115006, harry_ren@126.com
About this study
This is a single arm, open-label exploratory study conducted in resectable stage II-IIIA NSCLC without EGFR/ALK mutations, aiming to investigate feasibility, safety and efficacy of Sugemalimab in perioperative contexts. Twenty-five resectable stage II-IIIA patients are planned to be enrolled. The proportion of patients with squamous cell carcinoma will not less than 40%.
Combined neoadjuvant chemotherapy and immunotherapy with fixed dose of Sugemalimab 1200 mg IV Q3W + Platinum-based chemo in resectable stage II-IIIA NSCLC adult patients followed by surgery. After completion of neoadjuvant therapy (3-4 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression in neoadjuvant therapy. Pathological response is planned to assessed after surgery. Following surgery, the patients with complete resection will receive an additional 1 year of Sugemalimab q3w. Treatment will commence as soon as clinically feasible post-surgery.
Informed consent will be obtained prior to tissue collection and genome sequencing for each participant. Primary tumour tissue will be obtained at diagnosis by biopsy such as percutaneous lung puncture biopsy, bronchoscopic biopsy or endobronchial ultrasound (EBUS) (based on clinical practice). Fresh tumour tissue was collected after surgical resection. Tissues collected were subjected to medically necessary pathology for diagnosis. Specimens were processed for multiplex immunofluorescence, single-cell sequencing and spatial transcriptomics, bulk RNAseq and WES to explore the changes in the immune microenvironment before and after suglizumab administration.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab
- Keywords
- Neoadjuvant, NSCLC, immunotherapy, adjuvant
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant SugemalimabDrug
Patients will receive 3-4 cycles of neoadjuvant treatment with preoperative suglizumab in combination with chemotherapy, followed by surgery. After surgery, patients will receive 1-4 cycles of platinum-containing adjuvant chemotherapy，followed by 1 year of adjuvant sugemalimab.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative immunotherapy group | Experimental | Neoadjuvant Sugemalimab + Chemotherapy Followed by adjuvant Sugemalimab Receives: Drug: Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response
Major Pathological Response (≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes)
Measured: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy
Secondary outcomes (2)
Pathological Complete Response
0% residual viable tumor cells in the primary tumor and sampled lymph nodes
Measured: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy
Event-free survival rate
Event-free survival rate at 6 /12 /18 months
Measured: 6 /12 /18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start19 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Ren Shengxiang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987734
- Sponsor's protocol ID
- L23-385-01
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 26 Jun 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06987734
- Acronym / sponsor ID
- L23-385-01
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Neoadjuvant, NSCLC, immunotherapy, adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 23 May 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 is a single arm, open-label exploratory study conducted in resectable stage II-IIIA NSCLC without EGFR/ALK mutations, aiming to investigate feasibility, safety and efficacy of Sugemalimab in perioperative contexts. Twenty-five resectable stage II-IIIA patients are planned to be enrolled. The proportion of patients with squamous cell carcinoma will not less than 40%.
Combined neoadjuvant chemotherapy and immunotherapy with fixed dose of Sugemalimab 1200 mg IV Q3W + Platinum-based chemo in resectable stage II-IIIA NSCLC adult patients followed by surgery. After completion of neoadjuvant therapy (3-4 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression in neoadjuvant therapy. Pathological response is planned to assessed after surgery. Following surgery, the patients with complete resection will receive an additional 1 year of Sugemalimab q3w. Treatment will commence as soon as clinically feasible post-surgery.
Informed consent will be obtained prior to tissue collection and genome sequencing for each participant. Primary tumour tissue will be obtained at diagnosis by biopsy such as percutaneous lung puncture biopsy, bronchoscopic biopsy or endobronchial ultrasound (EBUS) (based on clinical practice). Fresh tumour tissue was collected after surgical resection. Tissues collected were subjected to medically necessary pathology for diagnosis. Specimens were processed for multiplex immunofluorescence, single-cell sequencing and spatial transcriptomics, bulk RNAseq and WES to explore the changes in the immune microenvironment before and after suglizumab administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perioperative immunotherapy group | Experimental | Drug: Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant SugemalimabNeoadjuvant Sugemalimab + Chemotherapy Followed by adjuvant Sugemalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Patients have voluntarily to join the study and give written informed consent for the study.
- Histologically documented, stage II-IIIA Non-Small Cell Lung Cancer (according to version 9th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated.
- Tumor should be considered resectable before study entry by a multidisciplinary team.
- ECOG Performance Status of 0 or 1
Key exclusion criteria (5 listed)
- 1) All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
- 2) Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
- 3) Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy 4) Severe acute or chronic infections, including: hepatits B, hepatits C, HIV etc 5) Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
- 6) Histologically confirmed adenosquamous carcinoma 7) Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins 8) Subjects have interstitial lung disease (ILD), or a history of ILD that required corticosteroid treatment.
- 9) Women in pregnancy or lactation. 10) Patients who are allergic to any of the agent or any ingredient
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 |
|---|---|---|
| Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant SugemalimabPatients will receive 3-4 cycles of neoadjuvant treatment with preoperative suglizumab in combination with chemotherapy, followed by surgery. After surgery, patients will receive 1-4 cycles of platinum-containing adjuvant chemotherapy，followed by 1 year of adjuvant sugemalimab. | Drug | Perioperative immunotherapy group |
Primary outcome
Major Pathological Response
Time frame: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy
Major Pathological Response (≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes)
2 secondary outcomes
Pathological Complete Response
Time frame: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy
Event-free survival rate
Time frame: 6 /12 /18 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 26 Jun 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.
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 Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab in people with Lung Cancer (NSCLC), 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 17 inclusion and 5 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 26 Jun 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 shengxiang ren Ren, Pro. (13816756732, harry_ren@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (time frame: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy). 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 26 Jun 2025.